パーキンソン病における注意と目の動き
2026年4月30日 更新者：University of Nebraska
パーキンソン病の知覚的および認知的結果における注意の役割を調査する
この観察および介入研究の目標は、パーキンソン病（PD）および必須振戦（ET）の参加者の注意、知覚、認知に治療的な深部脳刺激（DBS）がどのように影響するかを理解することです。 それが答えることを目指している主な質問は次のとおりです。
- PDの注意と眼の動きの制御障害は、社会的手がかりがどのように認識され解釈されるかを変えるのでしょうか？
- Therapeutic DBSは、PDおよびETの社会的手がかりの注意と知覚の欠陥を改善または悪化させますか？
- 障害の他の側面に対して効果的な治療を維持しながら、PDの通常の注意制御を回復するためにDBSを最適化することができます。
- DBSが標的とする脳の部分は、注意の制御にどのような貢献していますか？
視力カメラを使用して、研究者は、ET、PD、またはDBSのない健康な参加者のグループと比較して、PDを持つ参加者がDBS療法を開始する前後に感情の表情を見て知覚する方法を研究します。 PDとETの参加者は、3つの条件でコンピューター画面にモーフィングされた表情を表示および評価します。
- DBS療法を開始する前（約1時間以上）。
- 手術室では、DBS電極をインプラントするための標準的な手順中に、参加者が目を覚ましている間（15分以内）。
- DBS療法を開始した後、DBS刺激レベルと頻度の短い実験的変化（約1時間以上）。
調査の概要
詳細な説明
パーキンソン病（PD）は、2番目に一般的な加齢に伴う神経変性障害であり、北米で年間約90,000件の新しい症例が診断されています。 運動症状は障害を定義しますが、PDは、表情を認識したり、注意を調節するのが難しいなど、認知的および感情的な変化にもつながります。 この研究の目標は、PDにおける注意、眼の動き、感情的な知覚の間のリンクをよりよく理解し、注意を混乱させたという仮説をテストすることが、顔の感情の認識の変化につながるという仮説をテストすることです。 この研究では、視床下核（STN）の深部脳刺激（DBS）がこれらのプロセスにどのように影響し、治療の認知的および知覚的結果に関する重要な洞察を提供するかを調査します。
この研究は、注意、眼の動き、知覚がどのように相互作用するかを探ることにより、パーキンソン病の非運動症状を理解する上での重大なギャップに対処します。 調査結果は、PDの認知症状と感情的症状が注意制御の障害に起因するかどうかについての証拠を提供し、これらの障害を治療するための新しいフレームワークを提供します。 さらに、この研究は、異なるDBS頻度が知覚と認知にどのように影響するかについて明らかになり、運動症状と非運動症状の両方を緩和するためにパーソナライズされた刺激戦略を導く可能性があります。 得られた洞察は、PDの将来の治療に影響を与え、科学的知識と患者のケアの両方を進めています。
参加者は、DBSを経験しているPD、DBS（非PD DBS効果の比較グループとして）を受けるPD、および健康な年齢および性的慣行のコントロールの3つのグループに分けられます。 参加者は、眼球の動きが追跡されている間、顔のモーフ評価タスク（幸せ、中立、または悲しいと評価された顔）と視覚検索タスク（ディストラクタの間で顔を見つける）を完了します。
最初の研究の目的は、参加者が感情的な顔の刺激を見て分類しながら、目の動きを追跡することにより、注意の変化がPDの顔の感情知覚にどのように影響するかを測定することです。 2番目の目的は、覚醒DBS手術中の注意および知覚プロセスに関連するSTNの脳活動を特徴づけることです。神経活動の微小電極記録（MER）を捕獲することにより、参加者は感情的な顔を見て、研究者が注意と目の動きを導く際のSTNの役割をマッピングできるようにします。 3番目の目的は、さまざまな周波数（高、低、またはオフ）でのDBS刺激が、脳の刺激が認知機能と知覚機能にどのように影響するかを評価するために、参加者にさまざまなDBS設定の下で視覚的および知覚的タスクを実行させることにより、注意、眼球運動、および感情的知覚にどのように影響するかをテストすることです。
研究の種類
介入
入学 (推定)
138
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Dulce Maroni, PhD
- 電話番号：402-836-9751
- メール：dmaroni@unmc.edu
研究連絡先のバックアップ
- 名前：Christopher K Kovach, PhD
- 電話番号：319-471-3372
- メール：ckovach@unmc.edu
研究場所
-
-
Nebraska
-
Omaha、Nebraska、アメリカ、68198
- 募集
- University of Nebraska Medical Center
-
コンタクト：
- Dulce V Maroni, PhD
- 電話番号：402-836-9751
- メール：dmaroni@unmc.edu
-
主任研究者：
- Christopher K Kovach, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
包含基準
すべての参加者（AIM 1）：
- この研究のために署名されたインフォームドコンセントを提供する能力と意欲
- ボタンプレスまたはマウス制御コンピュータースライダーを介して知覚的判断を表現する能力
- 19〜90歳
DBS参加者（AIM 1）：
- 特発性パーキンソン病（PD）または必須振戦（ET）の診断
- 視床下核（STN）、視床（VIM）の腹側中間核または内部球状球（GPI）を標的とする治療DBSデバイスの新しい移植が予定されています
比較参加者（AIM 1）：
o PDグループの参加者との年齢マッチングによる選択
パーキンソン病（PD）および必須振戦（ET）参加者（AIM 2）：
- この研究のために署名されたインフォームドコンセントを提供する能力と意欲
- ボタンプレスまたはマウス制御コンピュータースライダーを介して知覚的判断を表現する能力
- 19〜90歳
- 臨床微小電極記録（MER）を使用した目覚めるDBS移植が予定されています
- 目覚める外科的処置中にタスクに喜んで従事することができます
パーキンソン病（PD）およびエッセンシャルトーマー（ET）参加者（AIM 3）：
- この研究のために署名されたインフォームドコンセントを提供する能力と意欲
- ボタンプレスまたはマウス制御コンピュータースライダーを介して知覚的判断を表現する能力
- 19〜90歳
- DBSの急性操作を喜んで受ける
- DBSの急性変化に耐えることができます
除外基準
すべての参加者（AIM 1）：
- 矯正された視力は、顔の刺激を知覚的に判断するには不十分です
- タスクの指示または完全なタスク要件を理解できない
DBS参加者（AIM 1）：
oボタンを押す必要があるタスクに従事するための運動症状の治療制御が不十分またはスライダーを制御するためにマウスの使用を必要とする
健康な比較参加者（AIM 1）：
o神経変性障害の歴史
パーキンソン病（PD）および必須振戦（ET）参加者（AIM 2）：
- 矯正された視力は、顔の刺激を知覚的に判断するには不十分です
- タスクの指示または完全なタスク要件を理解できない
- 目覚めたDBS移植を受けていません
- 補正されていない視力は、顔の刺激を知覚的に判断するには不十分です
パーキンソン病（PD）およびエッセンシャルトーマー（ET）参加者（AIM 3）：
- 矯正された視力は、顔の刺激を知覚的に判断するには不十分です
- タスクの指示または完全なタスク要件を理解できない
- 運動症状に治療効果を達成できなかった
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：DBSの急性変化
この研究の単一の腕のすべての参加者は、1時間にわたって無作為化順序で3つの条件下でDBS刺激の急性変化を受けます。
|
参加者は、臨床的に決定された治療頻度と電流で約20分にわたって提供される深い脳刺激を受けます。
参加者は、臨床的に決定された治療頻度で提供された深い脳刺激を受け、約20分間で電流を減らします（50％）。
参加者は、臨床的に決定された治療電流と約20分間で減少（4 Hz）頻度で提供された深い脳刺激を受けます。
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Facial Expression Rating
時間枠：Baseline (within 2 weeks pre-DBS implantation), intraoperative (Day 0; day of DBS implantation surgery, and post-operative follow-up (2-3 weeks after DBS implantation, following clinical optimization of stimulation parameters).
|
Participants will rate facial expression along a continuous scale using a computerized slider, following the affective bias task (ABT) of Bijanki et al. (2014).
The scale is anchored with three descriptors, "Very Sad" at slider value 0 (left), "Neutral", at position 0.5 (middle), and "Very Happy" at 1.0 (right).
Responses are compared between two time points: (1) at the initial pre-surgical testing session and post DBS implantation and (2) at the post-implantation session following clinical optimization of therapeutic parameters, 2-3 weeks after surgery.
The comparison will examine both the direction of any bias of the rating, against normative ratings, and the magnitude of average deviation from normative ratings.
Finally, the ratings will be incorporated into a generalized linear model of gaze position (Kovach 2014) to identify the association between perceived facial expression and characteristic fixation patterns.
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Baseline (within 2 weeks pre-DBS implantation), intraoperative (Day 0; day of DBS implantation surgery, and post-operative follow-up (2-3 weeks after DBS implantation, following clinical optimization of stimulation parameters).
|
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Eye Tracking
時間枠：Baseline (within 2 weeks pre-DBS implantation), intraoperative (Day 0; day of DBS implantation surgery, and post-operative follow-up (2-3 weeks after DBS implantation, following clinical optimization of stimulation parameters).
|
The location and duration of gaze fixations will be recorded with a remote eye tracking camera.
The location of gaze fixations will be treated as the dependent measure within a generalized linear modeling (GLM) framework for spatial point processes, described in Kovach and Adolphs (2014).
Parameter estimates of the model give the log relative risk of fixation at different locations in the visual scene as a function of the independent measures of the model.
Independent measures include the main effect of (1) Fourier basis functions encoding scene location and its interactions with (2) image rating in the affective bias task of Bijanki et.
al (2014), (3) session and (4) DBS stimulation state.
Measures derived from the GLM model will also include the statistical deviation (e.g.
Kullback-Leibler divergence) from the average distribution of fixations observed in healthy comparison subjects for each image.
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Baseline (within 2 weeks pre-DBS implantation), intraoperative (Day 0; day of DBS implantation surgery, and post-operative follow-up (2-3 weeks after DBS implantation, following clinical optimization of stimulation parameters).
|
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Intraoperative Microrecordings
時間枠：Intraoperative (Day 0; day of DBS implantation surgery).
|
During the Aim 2 portion of the study, patients undergoing awake DBS surgery as part of standard clinical care will engage in a subset of the face rating tasks during the surgery.
Invasive recordings will be obtained from DBS target structures, including STN, VIM, and GPi using microelectrodes that are placed as part of standard clinical practice.
Spike sorting will be used to identify firing of individual cells and firing rate will compared to eye movements to identify responses associated with shifts of attention in the targeted deep brain structures .
These measures will be compared across movement-disorders populations using mixed-effects linear modeling and other standard statistical procedures.
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Intraoperative (Day 0; day of DBS implantation surgery).
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
EEG beta-band power during emotional face rating
時間枠：Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
Spectral power in the beta frequency band (12-30 Hz), expressed in microvolts squared (µV²) and normalized to a pre-stimulus baseline, computed from non-invasive scalp EEG over posterior electrodes during the emotional face rating component of the task.
Measurement tool: 64-channel research-grade scalp EEG with time-frequency decomposition (demodulated band transform).
Group comparisons across PD, ET, DT, and healthy controls and within-participant comparisons across DBS conditions will be made using mixed-effects linear models, comparing power at baseline and modulation of power within a -0.5 to 0.5 s peri-saccade window.
|
Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
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EEG event-related potential (ERP) amplitude at saccade onset
時間枠：Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
Mean amplitude (µV) of the stimulus-locked event-related potential at saccade onset, measured over occipito-temporal electrodes during the 100-300 ms post-stimulus interval (encompassing the N170 component).
Measurement tool: 64-channel research-grade scalp EEG with stimulus-locked averaging.
|
Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
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EEG beta burst rate, frequency and amplitude during emotional face viewing
時間枠：Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
Modulation of beta band activity (12-30 Hz), will be studied in scalp EEG recordings using a published method (Kovach 2026) for identifying oscillatory bursts based on estimation and decomposition of the fourth order spectrum (trispectrum).
Group comparisons across PD, ET, DT, and healthy controls and within-participant comparisons across DBS conditions will be made using mixed-effects linear models, comparing burst rate, amplitude and frequency comparing power at baseline and modulation of power within a -0.5 to 0.5 s peri-saccade window.
|
Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
|
LFP beta-band (12-30 Hz) power during emotional face viewing
時間枠：Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
Spectral power in the beta band (12-30 Hz), expressed in microvolts squared (µV²), recorded from chronically implanted DBS electrodes targeting the subthalamic nucleus during eye-tracked task performance.
Measurement tool: voltage telemetry through clinical leads using the BrainSense capability of the Medtronic Percept implantable pulse generator.
Power will be computed via time-frequency decomposition (demodulated band transform) and compared across DBS conditions (normal therapeutic, reduced current, reduced frequency) and across movement-disorder populations using mixed-effects linear models.
|
Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
|
LFP beta burst rate, frequency and amplitude during emotional face viewing
時間枠：Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
Modulation of beta band activity (12-30 Hz), will be studied in intracranial LFP recordings using a published method (Kovach et al. 2026) for identifying oscillatory bursts based on estimation and decomposition of the fourth order spectrum (trispectrum).
Group comparisons across PD, ET, DT, and healthy controls and within-participant comparisons across DBS conditions will be made using mixed-effects linear models, comparing burst rate, amplitude and frequency comparing power at baseline and modulation of power within a -0.5 to 0.5 s peri-saccade window.
|
Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
|
LFP theta-band (4-8 Hz) power during emotional face viewing
時間枠：Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
Spectral power in the theta frequency band (4-8 Hz), expressed in microvolts squared (µV²) and normalized to a pre-stimulus baseline, computed from non-invasive scalp EEG over fronto-central electrodes during presentation of morphed emotional face stimuli in the affective bias task (Bijanki et al., 2014).
Measurement tool: voltage telemetry through clinical leads using the BrainSense capability of the Medtronic Percept implantable pulse generator.Group comparisons across PD, ET, DT, and healthy controls and within-participant comparisons across DBS conditions will be made using mixed-effects linear models, comparing power at baseline and modulation of power within a -0.5 to 0.5 s peri-saccade window.
|
Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
|
EEG-LFP coherence during emotional face viewing
時間枠：Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
Coherence between scalp EEG recordings and intracranial LFP recordings will be examined across multiple frequencies from 1 Hz to 30 Hz using a time-frequency decomposition (demodulated band transform, Kovach 2016) with 1 Hz frequency bins.
Measurement tool: 64 channel scalp EEG and concurrent voltage telemetry through clinical leads using the BrainSense capability of the Medtronic Percept implantable pulse generator.
Group comparisons of subject-level coherence values across PD, ET, DT, and healthy controls and within-participant comparisons across DBS conditions will be made using mixed-effects linear models, comparing power at baseline and modulation of power within a -0.5 to 0.5 s peri-saccade window.
|
Single experimental visit during the Aim 3 study session (third study visit; through study completion, an average of 6 months).
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Christopher K Kovach, PhD、University of Nebraska
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年9月22日
一次修了 (推定)
2028年2月1日
研究の完了 (推定)
2028年8月1日
試験登録日
最初に提出
2025年3月14日
QC基準を満たした最初の提出物
2025年3月20日
最初の投稿 (実際)
2025年3月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月5日
QC基準を満たした最後の更新が送信されました
2026年4月30日
最終確認日
2026年3月1日
詳しくは
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