kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery
調査の概要
詳細な説明
The goal of this pilot clinical trial is to assess the feasibility and preliminary efficacy of kTMP on upper limb motor recovery in chronic stroke compared to sham. We will conduct a 6-week double-blind, randomized, sham-controlled pilot study to test the beneficial influence of kTMP combined with simple motor tasks on kinematic outcomes such as range of motion of the upper arm, hand and fingers.
After baseline assessments, participants will be randomly allocated to either the kTMP group or the Control group. Participants, experimentalists, and outcome assessors will be blinded to group allocation. kTMP will begin within 1 week following randomization and will be delivered three times a week for 6 weeks. The primary endpoint will be assessed at the end of treatment, with follow-up assessments occurring 1 month, 3 months and 6 months following treatment completion. There is one assessment 4 weeks into the treatment phase to assess if patients continue to improve from 4 to 6 weeks of treatment.
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：Ludovica Labruna, PhD
- 電話番号：5104237125
- メール：participate@magnetictides.com
研究場所
-
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California
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San Francisco、California、アメリカ、94158
- 募集
- UCSF Mission Bay- Sandler Neurosciences Center
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コンタクト：
- Christina Merrick
- 電話番号：510-423-7125
- メール：participate@magnetictides.com
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主任研究者：
- Ludovica Labruna, PhD
-
主任研究者：
- Richard Ivry, PhD
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主任研究者：
- Karunesh Ganguly, MD
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-
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:
- Adults aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.
- Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.
- Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
- Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).
Exclusion criteria:
- Participants with moderate or severe cognitive impairment (MoCA < 18).
- Participants with sensory deficits FMA-S < 6/12 (with proprioception < 4/8).
- Participants with severe apraxia (TULIA < 5).
- Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
- Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
- Pregnancy or plans to become pregnant during the study period.
- Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study.
- Severe spasticity of the affected upper limb (Modified Ashworth ≥ 4).
- Absolute contraindications related to non-invasive brain stimulation, including:
9a) History of seizures in the last 12 months while taking anti-epilepsy medication 9b) Presence of any metal implants in the head (excluding the mouth), such as cortical stimulators and DBS, clips, coils, shunts, stents or skull plates, cochlear implants 9c) Permanent eye liner or head tattoos 9d) Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator 9e) History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session
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：処理
- 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 |
|---|---|
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実験的：アクティブKTMP
参加者は8 V/mの積極的な刺激を受けました
|
新しい非侵襲的脳刺激ツール
|
|
偽コンパレータ：Sham kTMP
Participants receive sham stimulation (0.0 V/m electric field)
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偽設定が選択された新しい非侵襲的脳刺激ツール
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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 |
|---|---|---|
|
Range of Joint Motion (ROM)
時間枠：6 weeks
|
defined as the standard deviation of the joint angle time series for a given trial.
The median ROM will be calculated for eleven degrees of freedom and then averaged.
If there are joints which appear to be compensatory, they will be removed from the analysis
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6 weeks
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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 |
|---|---|---|
|
Fugl- Meyer Assessment (Upper Extremity)
時間枠：6 weeks
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A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment.
It is graded from 0 (hemiplegia) to 66 for the Upper extremity.
Higher scores signifies better motor control, and hence a better outcome.
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6 weeks
|
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Modified Ashworth Scale (MAS)
時間枠：6 weeks
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Used to measure spasticity in wrist and hand flexors and extensors.
It assigns a grade of spasticity from 0-4.
Lower scores represent normal muscle tone and higher scores represent spasticity.
Hence lower scores are associated with better outcomes.
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6 weeks
|
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Transport Time
時間枠：6 weeks
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Calculated for each of three epochs, pre, during and post
|
6 weeks
|
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Trial to Trial Variability (T2TV)
時間枠：6 weeks
|
Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries.
The median T2TV will be calculated for eleven degrees of freedom.
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6 weeks
|
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Grasp to Lift Time
時間枠：6 weeks
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Calculated for each of three epochs, pre, during and post
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6 weeks
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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
その他の研究ID番号
- kTMPstrokePilot
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?
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米国で製造され、米国から輸出された製品。
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