Transcranial Focused Ultrasound Neuromodulation for Post-Stroke Motor Dysfunction
Transcranial Focused Ultrasound Neuromodulation in Post-Stroke Motor Dysfunction
This study aims to evaluate how transcranial focused ultrasound (tFUS) technology can promote neural network remodeling and functional recovery after stroke. By integrating signals from electroencephalography (EEG) and magnetic resonance imaging (MRI), the study will investigate how activating or inhibiting specific brain regions affects motor and cognitive recovery. The goal is to improve patients' motor and cognitive functions, reduce long-term disability, and enhance quality of life. The study also seeks to optimize stimulation parameters to maximize rehabilitation outcomes and explore the mechanisms underlying neuroprotection and functional reconstruction after stroke.
This is a case-control study involving a total of 60 participants. Participants will be ischemic stroke survivors aged 18-75 years, with first-ever stroke onset between 21 days and 6 months, stable vital signs, no consciousness disorders, and the ability to provide informed consent and cooperate with assessments. Eligible participants must have unilateral limb motor impairment, with an upper extremity modified Ashworth score ≤3, Brunnstrom stage II-V, and an upper extremity Fugl-Meyer Assessment (FMA-UE) score between 15 and 60.
Participants will be assigned to either a neuromodulation group (receiving multi-modal neuromodulation targeting specific brain regions) or a control group (receiving sham stimulation or conventional treatment). Primary outcome measures include changes in FMA-UE scores, neuroimaging data (CT/MRI), EEG measurements (resting-state and task-state spectral power, functional connectivity), and laboratory markers (complete blood count, CRP, IL-6, S100β, BDNF). Secondary outcome measures include Brunnstrom stage, Ashworth grade, muscle strength, and patient comfort ratings. Safety will be monitored through blood routine tests, blood biochemistry, and coagulation function.
Statistical analysis will compare key indicator changes between the neuromodulation and control groups before and after intervention. Independent t-tests (for two groups) or ANOVA (for multiple groups) will be used to assess between-group differences, with non-parametric tests applied for data not following a normal distribution.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xiao Zhang, Professor
- 電話番号：+86 18612228766
- メール：zhangxiao@hit.edu.cn
研究場所
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国、150001
- Harbin Institute of Technology
-
コンタクト：
- Xiao Zhang, Professor
- 電話番号：+86 18612228766
- メール：zhangxiao@hit.edu.cn
-
-
参加基準
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
説明
Inclusion Criteria:
- (1) Patients with a confirmed imaging diagnosis of first-ever ischemic stroke; (2) Unilateral limb motor involvement; (3) Modified Ashworth Scale (MAS) grade ≤3 for the upper extremity, Brunnstrom stage II-V, and upper extremity Fugl-Meyer Assessment (FMA-UE) score between 15 and 60 (inclusive); (4) Age 18-75 years, onset within 21 days to 6 months, in the subacute or recovery phase; (5) Stable vital signs, no consciousness impairment, informed consent provided, ability to cooperate with clinical assessments, and approval obtained from the institutional ethics committee.
Exclusion Criteria:
- (1) Contraindications to MRI; (2) Infarction involving the thalamus; (3) Risk of intracranial hemorrhage; (4) Presence of intracranial metallic foreign bodies, cardiac pacemakers, or cochlear implants; (5) Unstable medical condition, severe cognitive impairment or psychiatric disorders rendering the patient unable to comprehend the study or cooperate with assessments; (6) Conditions affecting limb motor function, including fractures, joint contractures, or severe limb spasticity; (7) Current use of medications that alter cortical excitability.
研究計画
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Neuromodulation Group
Multimodal neuromodulation targeting specific neural regions in addition to conventional therapy.
|
The transcranial focused ultrasound stimulation device employed in this study is the NeuroFUS DPX-500, equipped with a 4-element transducer array and the BrainSight neuronavigation system.
Individualized modeling and target segmentation are performed using high-resolution structural MRI and CT images acquired at baseline.
Target planning and neuronavigation are conducted based on intracranial acoustic field simulation.
The total stimulation duration is 12 minutes, comprising 480 pulse trains with 0.5 seconds on and 1 second off, yielding a duty cycle of 20%.
|
|
偽コンパレータ：Control Group
Sham stimulation in addition to conventional therapy.
|
The control group receives sham stimulation during the neuromodulation phase.
All procedural steps are identical to those of the experimental group, including neuronavigation positioning, application of coupling gel, and all other preparatory procedures; however, ultrasound stimulation is not activated.
Participants in the control group wear bone-conduction headphones to simulate and counteract acoustic confounding.
Group allocation information is blinded to participants.
|
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 |
|---|---|---|
|
Upper extremity Fugl-Meyer Assessment (UE-FMA) motor score
時間枠：Baseline (Day 1), Day 7 ( after the 5-day intervention), and Day 21 (2-week follow-up)
|
Upper extremity motor function assessed by the Fugl-Meyer Assessment (motor subscale).
Total score ranges from 0 to 66, with higher scores indicating better motor function.
|
Baseline (Day 1), Day 7 ( after the 5-day intervention), and Day 21 (2-week follow-up)
|
|
Resting-state EEG spectral power
時間枠：Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
Resting-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands.
|
Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
|
Task-state EEG spectral power
時間枠：Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
Task-state EEG spectral power in the delta, theta, alpha, beta, and gamma frequency bands.
|
Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
|
Resting-state fMRI fractional ALFF (fALFF)
時間枠：Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
fALFF derived from resting-state functional MRI, the ratio of low-frequency power to whole-frequency power.
|
Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
|
Resting-state fMRI regional homogeneity (ReHo)
時間枠：Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
ReHo (Kendall's coefficient of concordance) from resting-state functional MRI, reflecting local synchronization of neuronal activity.
|
Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
|
Resting-state fMRI functional connectivity (FC)
時間枠：Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
Functional connectivity between regions of interest derived from resting-state functional MRI (Fisher z-transformed correlation coefficients).
|
Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Brunnstrom recovery stage of the affected upper limb
時間枠：Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
|
Motor recovery staged using the Brunnstrom approach, an ordinal scale from Stage 1 (flaccid, no movement) to Stage 6 (near-normal coordination), with higher stages indicating better motor recovery.
|
Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
|
|
Modified Ashworth Scale (MAS) grade of the affected upper limb
時間枠：Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
|
Muscle spasticity graded with the Modified Ashworth Scale, an ordinal scale with 6 levels (0, 1, 1+, 2, 3, 4); higher grades indicate greater spasticity (a worse outcome).
|
Baseline (Day 1), Day 7 (after the 5-day intervention), and Day 21 (2-week follow-up)
|
|
Fractional anisotropy (FA) on diffusion tensor imaging (DTI)
時間枠：Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
White-matter fractional anisotropy measured by diffusion tensor imaging.
Dimensionless (0-1), with higher values indicating greater directional coherence of water diffusion.
|
Baseline (Day 1) and Day 7 (after the 5-day intervention)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。