WO2009063435A1 - Appareil et procédé pour traiter un trouble visuel cortical par utilisation d'une stimulation magnétique transcrânienne - Google Patents

Appareil et procédé pour traiter un trouble visuel cortical par utilisation d'une stimulation magnétique transcrânienne Download PDF

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Publication number
WO2009063435A1
WO2009063435A1 PCT/IB2008/054792 IB2008054792W WO2009063435A1 WO 2009063435 A1 WO2009063435 A1 WO 2009063435A1 IB 2008054792 W IB2008054792 W IB 2008054792W WO 2009063435 A1 WO2009063435 A1 WO 2009063435A1
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WIPO (PCT)
Prior art keywords
stimulation
patient
visual
coil
rtms
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PCT/IB2008/054792
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English (en)
Inventor
Robert Hess
Lisa Koski
Behzad Mansouri
Benjamin Simon Thompson
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Mcgill University
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Publication of WO2009063435A1 publication Critical patent/WO2009063435A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/02—Magnetotherapy using magnetic fields produced by coils, including single turn loops or electromagnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N2/00—Magnetotherapy
    • A61N2/004—Magnetotherapy specially adapted for a specific therapy
    • A61N2/006—Magnetotherapy specially adapted for a specific therapy for magnetic stimulation of nerve tissue

Definitions

  • the present invention relates to the field of transcranial magnetic stimulation.
  • the present invention also relates to the field of treatment of cortical-based visual disorders.
  • Amblyopia a cortically based visual disorder caused by disruption of visual development during an early developmental critical period, is thought to be a largely intractable problem in adult patients due to a lack of plasticity after this critical period.
  • Monocular amblyopia is the largest cause of uniocular impairment in the adult population with an incidence of 3%.
  • Current treatment approaches emphasize patching or penalization of the non-amblyopic eye before 12 years of age. There is no treatment available for individuals outside of this critical period and although new approaches are being explored, current treatment alternatives are limited and often unsuccessful.
  • Amblyopia is a neurological disorder with a cortical basis, and no treatment approaches to date have aimed to directly affect the neural processing in visual cortex, rather either general pharmacological interventions have been used or treatments requiring the patching or penalization of one eye.
  • rTMS repetitive transcranial magnetic stimulation
  • rTMS is a way of directly influencing the neural processing of a fairly specific cortical region by repeatedly administering magnetic pulses to the head through a specially designed coil.
  • the magnetic field sets up an electrical current in the cortical tissue underneath it causing a population of the neurons in that tissue to fire.
  • TMS can have effects on cortical regions that last longer than the rTMS session itself.
  • Transcranial magnetic stimulation has also been studied as a potential therapy for other diseases such as stroke, aphasia, Parkinson's disease, amyotrophic lateral sclerosis, epilepsy, migraine.
  • the rTMS administration includes a range of administration frequencies (number of TMS pulses per second) and durations (the length of time for which the rTMS is applied).
  • the invention includes the apparatus required for the correct administration of the rTMS, including methods and apparatus for selecting the correct stimulation site in visual cortex which varies between patients, the correct stimulation intensity to use which also varies and criteria for the exclusion of patients for whom rTMS treatment is not appropriate.
  • rTMS repetitive transcranial magnetic stimulation
  • ICI intra-cortical inhibition
  • Contrast sensitivity is defined as the lowest contrast at which a person is able to reliably see a visual stimulus with a fixed spatial frequency.
  • Spatial frequency is related to the size of the features of the stimulus.
  • a grating with wide bars/stripes has a low spatial frequency as the pattern repeats itself infrequently (because the bars are wide).
  • a grating with very thin bars has a high spatial frequency as the pattern repeats itself frequently. Spatial frequency is measured in cycles per degree, the number of repetitions of the pattern within a single degree of visual angle. The higher the cycles per degree, the higher the spatial frequency.
  • TMS transcranial magnetic stimulation
  • the system could further comprise an interface for interfacing said coil position data with a robot for positioning said TMS coil.
  • the system could further comprise a module for physically positioning, repositioning and fixing a stimulation coil over a head of the patient.
  • the system could further comprise a module for recording vision test results from a patient before and after delivery of said stimulation to determine improvement of vision as a result of said stimulation.
  • the system could further comprise a user input device which allows the patient to enter responses during a vision task or during the phosphene experience phase for determining optimal location, intensity and frequency of stimulation.
  • It is an object of the present invention to provide an apparatus for treating a cortical-based visual disorder using delivery of repetitive transcranial magnetic stimuli to the visual cortex of a patient comprising a stimulation coil for delivering transcranial magnetic stimulation, said coil positioning adjusted over visual cortex on the basis of patient responses to the location of phosphenes in the visual field; and stimulation intensity adjusted on the basis patient comfort; and a control system which analyzes patient responses and adjusts any one of or any combination of stimulation location, frequency and intensity for maximal therapeutic benefit to said patient.
  • This apparatus can comprise a module for recording vision test results from a patient before and after delivery of said stimulation to determine improvement of vision as a result of said stimulation.
  • the stimulation coil can be positioned manually by an operator, the system also comprises a module/robotic arm for physically positioning, repositioning and fixing the stimulation coil over the head of a patient automatically, based on gross anatomical landmarks.
  • It is yet another object of the present invention to provide an apparatus for treating a cortical-based visual disorder such as amblyopia using delivery of repetitive transcranial magnetic stimuli to the visual cortex of a patient comprising a stimulation coil for delivering transcranial magnetic stimulation at a fixed location over the visual cortex, at a fixed intensity to ensure safety and a fixed frequency that does not induce phosphenes or discomfort in substantially all patients tested.
  • This apparatus can comprise a device such as a robotic arm which is interfaced with the treatment control system and designed to automatically position the stimulation coil over the visual cortex on the basis of gross anatomical structures of the head.
  • the coil can be integrated into a cap-like device which automatically espouses the shape of the patient's head.
  • CT computerized tomography
  • MRI magnetic resonance imaging
  • This device can be adapted for treatment of a patient outside a clinical or hospital setting such as in the home of a patient.
  • Applicant's experiments have shown that optimal frequency of stimulation is greater than 1 Hz as only a portion of patients responded at this frequency. Because 10 Hz was shown by applicants to increase contrast sensitivity in all patients tested, the optimal frequency is approximately equal to 10Hz.
  • the treatment control system comprises a user input device such as a dial, a button or any structure that allows a patient to select responses in a visual discrimination task for contrast sensitivity such as, but not limited to, letter-based, motion or orientation discrimination.
  • a visual discrimination task for contrast sensitivity such as, but not limited to, letter-based, motion or orientation discrimination.
  • the purpose of these visual tasks which can be performed monocularly or binocularly are to allow the system or the operator to evaluate the effect of transcranial magnetic stimulation. If the treatment control system or the operator determines an improvement in contrast sensitivity, then the stimulation location and intensity of the coil can be maintained. If however the visual task does not allow the system or operator to determine an improvement in some measure of visual acuity, then the location of stimulation can be changed and the intensity of stimulation can be increased.
  • Figure 1 shows the effects of 1 Hz rTMS on contrast sensitivity.
  • Figure 2 shows the effect of 1 Hz (a and c) and 10 Hz (b and d) rTMS over visual cortex for two patients who showed an increase in contrast sensitivity after 1 Hz rTMS for the amblyopic eye
  • Figure 3 is a schematic block diagram of the units embedded in the invention, namely the VISION-TMS package,
  • Figure 4 is a flow chart of the steps involved in one embodiment of the invention whereby repetitive TMS is applied to the primary visual cortex to treat a specific cortically based visual disorder, namely monocular amblyopia.
  • Figure 5 is a flow chart of the steps involved in a test for comfort for participants in one embodiment of the invention.
  • Figure 6 is a flow chart of the steps involved in screening for phosphenes (finding the optimal stimulation site) in one embodiment of the invention.
  • Figure 7 is a flow chart of the steps involved in finding the correct stimulation intensity at which to administer the rTMS.
  • Figure 8 is a complement to Figure 1 and comprises additional subjects demonstrating the effects of 1 Hz rTMS over visual cortex on contrast detection for amblyopic participants.
  • Figure 9 is a complement to Figure 2 and comprises additional subjects demonstrating the effects of 10 Hz rTMS over visual cortex on contrast sensitivity for amblyopic participants
  • Figure 10 is a 10-20 system representation of the skull and brain area of a patient.
  • rTMS is a technique that has been shown to depress intracortical inhibition after long trains of subthreshold repetitive magnetic stimuli at low frequency in the human motor cortex (Modugno, N., Curra, A., Conte, A., Inghilleri, M., Fofi, L., Agostino, R., Manfredi, M., and Berardelli, A. 2003. Clin.
  • rTMS has also been shown to modulate levels of brain derived neurotrophic factor (BDNF), a protein thought to be involved in recovery from monocular deprivation (Sale et al., 2007).
  • BDNF brain derived neurotrophic factor
  • contrast sensitivity was measured using a 2-up 1 down staircase technique with three measurements taken for each participant per eye/spatial frequency combination within each block of measurements (t1 -3). This method of measurement was used as it provided the best tradeoff between accuracy and speed of measurement as necessitated by the transient nature of rTMS effects.
  • Figure 1 shows the effects of 1 Hz rTMS on contrast sensitivity. Measurements were made pre-rTMS (t1 ), directly post rTMS (t2) and 30 minutes post rTMS (t3) for both the amblyopic eye (AME) and the fellow fixing eye (FFE) for high spatial frequencies (a and c) (10cpd for 4 patients, 20 cpd for 1 patient) and for low spatial frequencies (b) (1 cpd). rTMS was administered over visual cortex (a and b) and motor cortex (c).
  • TMS peripheral effects of TMS
  • a TMS induced effect in this case a twitch in the left FDI muscle
  • visual cortex rTMS was delivered over an optimal phosphene location close to the occipital poles. The optimal phosphene location was independently identified in each patient.
  • FIG. 3 is a schematic block diagram of the units embedded in the invention, namely the VISION-TMS package, which is applied for use of Transcranial Magnetic Stimulation (TMS) in the treatment of visual deficiencies with a cortical origin such as amblyopia.
  • the accompanying apparatus to the TMS machine consists of (a) TMS coil positional control unit (b) central processing unit (c) patient behavioral response unit and (d) visual presentation unit.
  • TMS coil positional control unit i. TMS cap with all the testing regions marked on it ii. Coil mounted on a helmet iii. 3D positioning system (with commercially available package brain-sight and MRI images) iv. Suspended non-automatic or semiautomatic weight bearing or robotic arm
  • Central processing unit i. Microchips or software to control TMS positioning, intensity calibration and treatment administration. ii. TMS machine iii. Registration and treatment procedure iv. Receive the feedback from patient and analyze and react appropriately
  • Patient behavioral response unit i. Eye-tracker ii. Keypad iii. Touch sensitive display d.
  • Figure 4 is a flow chart of the steps involved in one embodiment of the invention whereby repetitive TMS is applied to the primary visual cortex to treat a specific cortically based visual disorder, namely monocular amblyopia.
  • Figure 5 is a flow chart of the steps involved in a test for comfort for participants in one embodiment of the invention. Comfort testing is performed to define the maximum stimulation intensity that can be used without causing the patient discomfort.
  • Figure 6 is a flow chart of the steps involved in screening for phosphenes (finding the optimal stimulation site) in one embodiment of the invention.
  • the algorithm that receives feedback from the patient regarding the strength and location of phosphenes calculates the stimulation site that provided the most reliable, strong phosphene in a central region of the visual field. Phosphene perception is also verified by the algorithm by ensuring that phosphenes are distributed in a retinotopic nature around the visual field.
  • Figure 7 is a flow chart of the steps involved in finding the correct stimulation intensity at which to administer the rTMS. Stimulation calibration is achieved using reported phosphenes from the participant.
  • Figure 8 is a complement to Figure 1 and comprises additional subjects demonstrating the effects of 1 Hz rTMS over visual cortex on contrast detection for amblyopic participants.
  • TO rTMS
  • T1 directly after rTMS
  • T2 30 min after rTMS
  • T1 and T2 were normalized to the baseline (T0-T1 and T0-T2) and plotted on the y axis as a change in percentage of contrast relative to TO.
  • a positive difference therefore indicates an improvement in contrast sensitivity (more contrast required before rTMS than after).
  • Figure 10 is a 10-20 system representation of the skull and brain area of a patient.
  • the 10-20 system is an internationally known method to describe the location of scalp areas thus helping in the positioning of electrodes on said scalp for electroencephalography (EEG) procedures.
  • EEG electroencephalography
  • the system is based on the relationship between the location of an electrode and the underlying area of cerebral cortex wherein 10 and 20 refer to the percentage difference in distances between adjacent electrodes with respect to the front-back or right- left distance of the skull.
  • the primary visual cortex (V) is found mainly in the occipital lobe which is described as O1 and O2 on the drawing.
  • rTMS over visual cortex was found to have a beneficial effect in the applicant's sample of amblyopic patients. Contrast sensitivity was improved for high spatial frequencies in the amblyopic eye directly after rTMS and 30 after rTMS. Applicants hypothesize that this effect is mediated by reduced intra-cortical inhibition in visual cortex after rTMS which facilitates improved visual performance. There are, however, other possible mechanisms of rTMS action that should be considered. Low and high speed rTMS are thought to decrease and increase excitability of the stimulated region respectively. The efficacy of rTMS has been shown to rely on the recent history of activity in the stimulated neurons (Iyer, M. B., Schleper, N., and Wassermann, E. M., 2003.
  • rTMS will differentially affect these two neuronal populations.
  • either high or low frequency rTMS could be required to match or shift the balance in neuronal excitability in favor of the amblyopic eye and therefore increase acuity, either through a removal of inhibition of inputs from the amblyopic eye by the fellow eye or through facilitating the activity of neurons driven by the amblyopic eye.
  • a related consideration is the effect of rTMS on the neurochemistry of the stimulated region. It has been shown that increasing the global levels of dopamine in the brain improves acuity in the amblyopic eye and rTMS over motor cortex has been shown to increase dopamine release. However given the paucity of dopaminergic innervation in the visual cortex increase in local dopamine release may not in itself be a sufficient explanation for the effects of rTMS shown here. Furthermore, the hypothesis that a global level of dopamine increase may be responsible for improved acuity after rTMS does not account for the lack of an effect of rTMS over motor cortex on visual acuity, which presumably would also influence dopamine levels.
  • Figures 8 and 9 are presented as complements to the data of Figures 1 and 2, respectively, but with additional subjects.
  • seven of nine patients had responded to the stimulation at one or both of the two post-rTMS time points, and if these results were considered alone, the effect of rTMS was reliable at T2 in Figure 8B.
  • applicants have not been able to identify any distinguishing features for the non responders that would allow applicants to consider them as a clearly separate population.
  • seven of nine and eight of nine participants showed a reduction in contrast sensitivity at T1 and T2, respectively, for the non amblyopic eye, high spatial frequency condition presented in Figures 8A and 8B. The reduction was reliable for T2. No other conditions showed reliable rTMS-induced changes.
  • FIG. 8C and 8D shows a difference in the baselines between the two conditions for the most extreme data point (participant A.M.).
  • This participant had to be tested at different spatial frequencies in the 10 Hz condition because of a sustained improvement in contrast sensitivity in the amblyopic eye after the 1 Hz rTMS.
  • This improvement cannot be attributed only to the rTMS intervention, however, because A.M. had been recruited for a perceptual-training experiment in the intervening time between rTMS sessions.
  • there was no significant change in baseline sensitivity across the different stimulation sessions (p > 0.05), which were separated by at least 1 week, indicating that the effects of rTMS were transient.
  • rTMS Repetitive transcranial magnetic stimulation
  • the effects of rTMS are likely to be mediated by altered synaptic transmission in the cortex, as seen in the well-known phenomena of long-term potentiation and depression.
  • Contrast sensitivity was measured using single, 17° Gabor patches presented within a 1 second temporal envelope. Patients had to indicate whether the patches were oriented vertically or horizontally. Thresholds were measured using a 2 up 1 down staircase technique comprising six reversals (incorrect responses only), the last five of which were averaged to obtain the threshold. This procedure was repeated at least three times for each eye/spatial frequency combination in a random order within one 'block' of measurements, i.e. t1 , t2 and t3. The average of these measurements was used as the patient's threshold for that block. Stimuli were presented on a linearized lyama Vision Master Pro monitor using a ViSaGe visual stimulus generator (Cambridge Research Systems, UK). Patients performed the psychophysical task monocularly. An eye patch was used to occlude one eye.
  • Phosphene thresholds (the stimulation intensity required to evoke a phosphene - a visual event such as a brief flash that is not induced by light hitting the retina) were acquired over V1 and subsequently used to calibrate the intensity used during the rTMS administration.
  • participants were asked to wear a white swimming cap so that certain points from the international ten-twenty electrode system could be marked on their head.
  • participants were asked to wear blacked out swimming goggles so that light to their eyes was blocked, but they could still comfortably keep their eyes open.
  • the coil was placed at electrode site O1 (occipital pole) and single pulse stimulation at 50- 100% stimulator output was applied over a 1x1 cm 2 interval grid centered on O1.
  • O1 occipital pole
  • single pulse stimulation at 50- 100% stimulator output was applied over a 1x1 cm 2 interval grid centered on O1.
  • the coil was moved laterally to check that the reported phosphene moved contra-laterally.
  • no phosphenes were reported after stimulation of non-visual control site OZ located at the top of the head. Participants were asked to report the presence of static phosphenes and the site of stimulation that generated the strongest phosphene percept was chosen for the rTMS procedure.
  • a phosphene threshold was measured, defined as the lowest amount of stimulation that gave rise to the percept of a phosphene on five out of ten pulses. This procedure typically took approximately 30 minutes. To avoid effects of dark adaptation and to avoid discomfort from the light proof goggles patients wore during this procedure, patients were re-exposed to light at convenient intervals throughout testing.
  • motor cortex a region of cortex in the right hemisphere corresponding to primary motor cortex was stimulated with single pulses until a twitch in the relaxed left FDI muscle was either reported by the patient or observed by the second experimenter.
  • Repetitive TMS 1 Hz rTMS was delivered for 10 minutes (600 pulses) at 100% of threshold.
  • 10 Hz rTMS was delivered to visual cortex only at 100% of motor threshold since this was consistently lower than phosphene threshold and therefore safer.
  • 10 Hz rTMS was delivered in bursts of 5 second trains separated by 45 second inter train intervals (total 900 pulses).
  • One patient did not undergo the motor control condition but did show differential responses to 1 Hz and 10Hz visual cortex stimulation supporting the absence of a non-specific rTMS related confound.
  • 4 were stimulated over visual cortex on the first session.
  • TMS was administered using a MagStim Rapid2 biphasic stimulator and a MagStim figure-8 air-cooled coil.
  • the BrainSight Frameless ® stereotaxic system was used to monitor coil position to keep the position constant. Differences between 1 Hz and 10 Hz Stimulation Parameters
  • Phosphene thresholds were measured using single pulse stimulation resulting in relatively high thresholds (mean 85% maximum stimulator output, SD 7% for amblyopes and mean 72% Maximal Stimulation Output (MSO), SD 10% for controls).
  • MSO Maximal Stimulation Output
  • Initial pilot observations identified tolerability issues for 1 Hz stimulation over 600 pulses, so we adopted 600 pulses as our train length, a duration that has previously been shown to be effective.
  • 10Hz stimulation was intolerable at 100% single pulse phosphene threshold (lower absolute intensities have been used elsewhere), we therefore used 100% motor threshold since these were lower than phosphene thresholds (mean 69% MSO, SD 12% for amblyopes, mean 59% for controls, SD 10%).

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Abstract

Pour le traitement d'un trouble visuel cortical, on utilise une administration d'une stimulation magnétique transcrânienne (TMS) répétée sur le cortex visuel d'un patient. On utilise un module d'analyse de données d'imagerie cérébrale du patient pour générer des données de position d'enroulement pour régler une position d'un enroulement de TMS, ou un module destiné à enregistrer une position de phosphènes à l'intérieur d'un champ de vision éprouvé par le patient pour générer des données de position d'enroulement permettant d'ajuster et/ou de régler une position d'un enroulement de TMS, ou un module destiné à enregistrer les phosphènes éprouvés par le patient pendant un nombre d'événements de TMS pour déterminer des paramètres de thérapie par TMS répétées.
PCT/IB2008/054792 2007-11-14 2008-11-14 Appareil et procédé pour traiter un trouble visuel cortical par utilisation d'une stimulation magnétique transcrânienne WO2009063435A1 (fr)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012059917A1 (fr) * 2010-11-01 2012-05-10 Neuronix Ltd. Méthode et système pour positionner un dispositif de stimulation magnétique transcrânienne (smt)
EP2772281A4 (fr) * 2011-10-24 2015-05-06 Teijin Pharma Ltd Système de stimulation magnétique transcrânienne
WO2019083467A1 (fr) * 2017-10-27 2019-05-02 Arslan Umut Stimulateur électromagnétique pour le traitement de maladies oculaires
US10286222B2 (en) 2009-06-15 2019-05-14 Osaka University Magnetic stimulator

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000074777A1 (fr) * 1999-06-02 2000-12-14 Medinova Medical Consulting Gmbh Stimulation magnetique transcranienne permettant d'ameliorer la vision chez l'homme
US20030050527A1 (en) * 2001-05-04 2003-03-13 Peter Fox Apparatus and methods for delivery of transcranial magnetic stimulation
US20030073899A1 (en) * 2001-10-17 2003-04-17 Jarmo Ruohonen Method and apparatus for dose computation of magnetic stimulation
WO2003098268A1 (fr) * 2002-05-17 2003-11-27 Musc Foundation For Research Development Procede, appareil et systeme pour le positionnement automatique d'une sonde ou d'un capteur

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000074777A1 (fr) * 1999-06-02 2000-12-14 Medinova Medical Consulting Gmbh Stimulation magnetique transcranienne permettant d'ameliorer la vision chez l'homme
US20030050527A1 (en) * 2001-05-04 2003-03-13 Peter Fox Apparatus and methods for delivery of transcranial magnetic stimulation
US20030073899A1 (en) * 2001-10-17 2003-04-17 Jarmo Ruohonen Method and apparatus for dose computation of magnetic stimulation
WO2003098268A1 (fr) * 2002-05-17 2003-11-27 Musc Foundation For Research Development Procede, appareil et systeme pour le positionnement automatique d'une sonde ou d'un capteur

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10286222B2 (en) 2009-06-15 2019-05-14 Osaka University Magnetic stimulator
WO2012059917A1 (fr) * 2010-11-01 2012-05-10 Neuronix Ltd. Méthode et système pour positionner un dispositif de stimulation magnétique transcrânienne (smt)
EP2772281A4 (fr) * 2011-10-24 2015-05-06 Teijin Pharma Ltd Système de stimulation magnétique transcrânienne
EP2772282A4 (fr) * 2011-10-24 2015-05-06 Teijin Pharma Ltd Système de stimulation magnétique transcrânienne
US9682249B2 (en) 2011-10-24 2017-06-20 Teijin Pharma Limited Transcranial magnetic stimulation system
US10004915B2 (en) 2011-10-24 2018-06-26 Teijin Pharma Limited Transcranial magnetic stimulation system
WO2019083467A1 (fr) * 2017-10-27 2019-05-02 Arslan Umut Stimulateur électromagnétique pour le traitement de maladies oculaires

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