JP7111710B2 - 神経活動をモニタするためのシステム及び方法 - Google Patents
神経活動をモニタするためのシステム及び方法 Download PDFInfo
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Description
a.脳の標的神経組織に刺激を加えるステップと;
b.標的神経組織内にまたはその近くに埋め込まれた電極における刺激によって誘発された神経反応を検出するステップと
を含み、
刺激は、第1の期間によって分離された複数のバーストを含むパターン化信号を含み、各バーストは、第2の期間によって分離された複数のパルスを含み、第1の期間が第2の期間より長く、検出するステップは、第1の期間のうちの1つ以上の間に実行される方法が提供される。
図5a、図5b、及び図5cは、非治療的刺激(図5a)、治療的刺激(図5b)の間のERNA、及び治療的刺激から非治療的刺激への刺激の移行後のERNA(図5c)の周波数の変動を示す。ERNAの共鳴周波数は、ERNAの2つのピークの最大値間での時間の遅延の逆数を計算することにより測定した。他の実施形態では、共鳴周波数は、ERNAの検出されたピークの全最大値の間における時間の遅延の平均の逆数として計算することができる。さらなる実施形態では、共鳴周波数は、減衰振動子モデルを共鳴活動に適合させて固有周波数を抽出することによって、またはスペクトル分析(例えば、フーリエ変換、ウェーブレット変換)を実行することによって計算できる。波形のゼロ交差の間の時間を推定すること、または波形の他の特徴を使用することといった、周波数を推定するための他の技法も、この目的のために使用できる。
本発明者らは、加えられた刺激に対する誘発神経反応が共鳴活動を示すだけでなく、場合によっては誘発された活動は複数の共鳴を含んでいると判断した。図7a、図7b及び図7cは、それぞれ1.5mA、2.25mA、及び3.375mAで連続的なDBSに応答したERNAを示す。1.5mAでは、共鳴ERNAは単一のピークとして始まり、それは2つのピークにわずかに分岐し始めることが見て取れる。2.25mAでは、2つのピークの遅い方に優位性が切り替わる。しかし、1.5mAで優勢であった早期の方のピークは、より低い振幅で継続する。3.375mAでは、2つのピークが存在しており、遅い方のピークが優勢である。これらの複数の共鳴のピークは、異なる神経回路における活動に対応していると考えられている。これらの共鳴応答(または他の特徴、例えば時間的特性やスペクトルの特性)間の相対的な振幅は、治療の状態の指標となり得る。
図20~図23は、患者の症状及び関連するERNAの変化に対するDBSの好ましい効果のさらなる証拠を提示する。これらの図に示しているデータは、電極アレイを埋め込んだパーキンソン病の患者から収集されたものである。電極アレイを長期にわたり埋め込み、埋め込みの数ヶ月後にERNA及び運動状態の測定を行った。このときERNAと運動状態を測定することで、電極アレイとその神経環境が安定していることが推定できた。したがって、ERNAと運動状態との間で確認した関係は、急な術中の処置、または電極を挿入する数日以内に実施した検査の間に測定したそれらの関係よりも、患者の長期の状態を表している。そのような短期間の検査から得た知見は、おそらく治療的DBS自体の適用よりも、むしろ外科的な埋め込みの処置に関連付けられるパーキンソン病における運動障害の一時的な軽減を特徴とする「スタン作用」に混同される可能性があることが見出された。
<DBSは共鳴神経活動を誘発する>
バイオマーカーとして実行可能に使用できる誘発反応があるかどうかを判定するために、DBSパルスから生じる神経活動を調べた。誘発された活動を維持するために、非常に長い第2の位相を有する従来の非対称パルスを使用せず、広い記録帯域幅及び刺激用の対称二相パルスを使用して、刺激アーチファクトの持続時間を最小にした。
ERNAがSTNに対する電極の位置と共に変化することを立証するために、3本の刺激のない電極について記録しながら、4本のDBS電極のそれぞれに10秒間のバースト刺激を連続的に加えた。DBS埋め込み手術は、STN内の4本の電極のうちの2本、つまりDBSが通常最大の利得を有する背側STNの1本の電極と、腹側STNのもう1本について、位置決めすることを目的とした。電極の位置におけるこの変動により、STNの異なる領域からのERNA応答と核の外側のものとの比較が容易になった。STN-PD患者8名(n=16半球)では、刺激及び記録電極の位置によってERNAの振幅と形態の両方が異なることを見出した。図14は、1つの半球における各バーストの最後のパルスから得た例示的なERNAを示したものであり、最大の振幅及び最も明白な減衰振動形態を有する応答が、標的のSTN位置の2本の中央の電極で生じている。対照として、また、PSA内の遠位電極と視床の腹側の中間核の近位電極とを位置決めすることを意図した埋め込みの軌道を用いて、2名の本態性振戦患者(n=4半球)に、また約2ms超の誘発活動を誘発しないことが既に示されている振戦の別の標的に、刺激を加えた。
ERNAが治療上有効なDBSによって変調されたかどうかを調べるために、10名のSTN-PD患者(n=19半球)に対して60~90秒のブロックにおいて徐々に増加する電流の振幅(0.67~3.38mAの範囲)のパルススキップ式の刺激を加えた。概して、ERNAの第2のピーク及び後続のピークでは、潜時が漸近的に増加し、経時的にまた刺激の振幅が増加するとさらに離れるように広がり、共鳴活動の周波数の減少と一貫しているということが一貫して見出された(図5、図6、図21a~図21e)。多くの場合、第1のピークの潜時も増加したが、この変化はすべての記録で一貫しているわけではなかった。ピークの振幅もまた一般に変動があることが認められ、頻繁に各刺激ブロックの開始時に大きくなり、その後徐々に減少した。
刺激の臨床的有効性は、2.25mAで、刺激の直前及び60秒後に、パーキンソン病統一スケール(UPDRS、項目22及び23)に従って四肢の動作緩慢性及び硬直性を評価することによって確認された。両方の臨床徴候は2.25mAで有意に改善し、DBSが治療的であることを示した(ウィルコクソンの符号順位検定、動作緩慢性:Z=-3.62、p<0.001、硬直性:Z=-3.70、p<0.001)。
また、治療的なパルススキップ式の刺激の直前及び直後に、治療効果がウォッシュアウトされるときの活動の変化をモニタするために、60秒間のバースト刺激(以後、DBS前及びDBS後の状態と称する)を加えた。
72a、72b、72c、72d 電極
90 DBS送達システム
92 処理装置
94 信号発生器
96 測定回路
98 マルチプレクサ
100 中央処理装置
102 メモリ
104 入出力バス
106 電源
108 入力装置
110 出力装置
Claims (8)
- 脳の標的神経組織内にまたはその近くに埋め込むのに適した少なくとも1本の電極を有するリード、
前記少なくとも1本の電極のうちの1本以上に選択的に連結され、前記標的神経組織を刺激するための刺激を生成するように構成された信号発生器、
前記少なくとも1本の電極のうちの1本以上に選択的に連結され、前記刺激によって誘発された前記標的神経組織からの共鳴応答を検出するように構成された測定装置、
前記測定装置に連結され、前記検出された共鳴応答の1つ以上の波形特性を判定し、前記共鳴応答の前記1つ以上の判定された波形特性に基づいて前記刺激を適合させるよう前記信号発生器を制御するように構成された処理装置
を含み、前記刺激は、前記共鳴応答における隣接ピーク間で経過した時間に基づいて適合される、神経刺激システム。 - 前記1つ以上の波形特性が、前記検出された共鳴応答における第2のサイクルまたは後続のサイクルの少なくとも一部に基づいて判定される、請求項1に記載のシステム。
- 前記1つ以上の波形特性が、以下の
a)前記共鳴応答の周波数、
b)前記共鳴応答の時間包絡線、
c)前記共鳴応答の振幅、
d)前記共鳴応答の微細組織、
e)前記共鳴応答の減衰率、
f)前記刺激の開始と前記共鳴応答の時間的特徴の開始との間の遅延
の1つ以上を含む、請求項1に記載のシステム。 - 前記共鳴応答における2つの隣接ピーク間で経過した時間が、患者における運動の症状の緩和に関連する第1の所定の期間より短い場合に前記刺激が適合され、
前記患者における運動の症状の緩和に関連する前記第1の所定の期間は、3.5ms未満である、請求項1に記載のシステム。 - 前記刺激が、前記刺激と前記共鳴応答の1つ以上のピークとの間の時間に基づいて適合され、
前記刺激と前記共鳴応答のピークとの間に経過した時間が、患者における運動の症状の緩和に関連する第1の所定の期間と第2の所定の期間との間にある場合、前記刺激が適合され、
前記ピークが第1のピークであり、前記第1の所定の期間は6.5msであり、前記第2の所定の期間は7.5msである、請求項1に記載のシステム。 - 前記刺激と前記共鳴応答における第1のピークとの間に経過した時間が6.5msと7.5msとの間であり、前記刺激と、前記第1のピークに隣接する前記共鳴応答における第2のピークとの間に経過した時間が10msと11msの間である場合に前記刺激が適合される、請求項5に記載のシステム。
- 前記刺激が、第1の期間によって分離された複数のバーストを含むパターン化信号を含み、各バーストが第2の期間によって分離された複数のパルスを含み、前記第1の期間が前記第2の期間より長く、前記検出することは、前記第1の期間のうちの1つ以上の間に実行される、請求項1に記載のシステム。
- 神経刺激システムであって、
脳の標的神経組織内にまたはその近くに埋め込むのに適した少なくとも1本の電極を有するリード、
前記少なくとも1本の電極のうちの1本以上に選択的に連結され、前記標的神経組織を刺激するための刺激を生成するように構成された信号発生器、
前記少なくとも1本の電極のうちの1本以上に選択的に連結され、前記刺激によって誘発された前記標的神経組織からの共鳴応答を検出するように構成された測定装置、
前記測定装置に連結され、前記検出された共鳴応答の1つ以上の波形特性を判定するように構成された処理装置
を含み、
前記処理装置が、
前記1つ以上の波形特性及び1つ以上の第2の波形特性に基づいて、患者に関連する疾患の進行度または前記患者に提供される療法の効果を推定するように構成され、前記1つ以上の第2の波形特性は、前記共鳴応答の後に検出された第2の共鳴応答に基づいて判定される、システム。
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