Non-Invasive Neuromodulation for Essential Tremor: Long-Term Safety and Effectiveness Study
2026年8月17日 更新者：Ruijin Hospital
A Prospective, Single-Center, Single-Arm, Open-Label Clinical Study Evaluating the Long-Term Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) in Patients With Essential Tremor
This is a prospective, single-center, single-arm, open-label clinical study designed to evaluate the long-term efficacy and safety of non-invasive neuromodulation using transcutaneous afferent patterned stimulation (TAPS) in patients with essential tremor (ET).
Essential tremor is a common movement disorder that can significantly impair daily functioning and quality of life. Pharmacological treatments are often limited by suboptimal efficacy or adverse effects, highlighting the need for alternative therapeutic approaches.
In this study, eligible participants with essential tremor will receive TAPS treatment over a defined follow-up period. Clinical outcomes, including tremor severity, functional performance, and patient-reported outcomes, will be assessed longitudinally to evaluate treatment effectiveness. Safety will be monitored throughout the study by recording adverse events and device-related complications.
The results of this study aim to provide clinical evidence regarding the long-term therapeutic potential and safety profile of TAPS as a non-invasive neuromodulation strategy for essential tremor.
調査の概要
研究の種類
介入
入学 (推定)
50
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：Jun Liu, MD,PhD
- 電話番号：021-86-64370045
- メール：jly0520@hotmail.com
研究場所
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Shanghai、中国
- 募集
- Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
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コンタクト：
- Jun Liu, MD,PhD
- 電話番号：86-021-64370045
- メール：jly0520@hotmail.com
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-
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
いいえ
説明
Inclusion Criteria:
- Adults aged ≥18 and <75 years
- Clinical diagnosis of essential tremor (ET), characterized by postural and/or kinetic tremor, primarily affecting one or both upper limbs, with or without involvement of other body regions (e.g., head, voice, or lower limbs)
- At least one major hand task score ≥2 on the TETRAS (The Essential Tremor Rating Assessment Scale), and a score ≥3 on the Bain & Findley Activities of Daily Living (BF-ADL) scale
- Able and willing to provide written informed consent
Exclusion Criteria:
- Presence of implanted electronic medical devices (e.g., deep brain stimulator or cardiac pacemaker)
- History of thalamotomy or other neurosurgical procedures for tremor
- History of epilepsy
- Current treatment with botulinum toxin for upper limb tremor
- Skin lesions on the upper limb at the stimulation site (e.g., tumors, hemangiomas)
- Neurological disorders affecting the upper limbs
- Known allergy to device materials (e.g., silicone, cotton textiles)
- Pregnant women
- Intake of caffeine or excessive alcohol within 8 hours prior to enrollment
- Severe cardiovascular or cerebrovascular diseases, or other significant neurological disorders
- Inability to comply with study procedures or follow-up
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：処理
- 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 |
|---|---|
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実験的：TAPS Treatment
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A non-invasive, wearable neuromodulation device that delivers transcutaneous afferent patterned stimulation (TAPS) to modulate neural circuits associated with essential tremor.
The device is applied according to the study protocol over the treatment period.
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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 |
|---|---|---|
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Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score)
時間枠：Baseline; Day 1; 1 month; 3 months
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Change in tremor severity from baseline to each post-treatment time point, assessed using the The Essential Tremor Rating Assessment Scale (TETRAS).
The TETRAS score ranges from 0 to 64, with higher scores indicating more severe tremor.
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Baseline; Day 1; 1 month; 3 months
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Incidence of Adverse Events
時間枠：3 months
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Incidence, type, and severity of adverse events occurring after treatment initiation.
Adverse events will be graded according to standard criteria (e.g., CTCAE)
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3 months
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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 |
|---|---|---|
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Change in Activities of Daily Living (Blessed Functional Activities of Daily Living [BF-ADL] Score)
時間枠：Baseline; Day 1; 1 month; 3 months
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Change in activities of daily living from baseline to each post-treatment time point, assessed using the Blessed Functional Activities of Daily Living Scale (BF-ADL).
The BF-ADL score ranges from 0 to 17, with higher scores indicating greater functional impairment.
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Baseline; Day 1; 1 month; 3 months
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Change in Anxiety Severity (Hamilton Anxiety Rating Scale [HAMA])
時間枠：Baseline; 1 month; 3 months
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Change in anxiety severity from baseline to each post-treatment time point, assessed using the Hamilton Anxiety Rating Scale (HAMA).
The HAMA score ranges from 0 to 56, with higher scores indicating more severe anxiety.
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Baseline; 1 month; 3 months
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Change in Depression Severity (Hamilton Depression Rating Scale [HAMD])
時間枠：Baseline; 1 month; 3 months
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Change in depression severity from baseline to each post-treatment time point, assessed using the Hamilton Depression Rating Scale (HAMD).
The HAMD score ranges from 0 to 52, with higher scores indicating more severe depression.
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Baseline; 1 month; 3 months
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Change in Cognitive Function (Montreal Cognitive Assessment [MoCA])
時間枠：Baseline; 1 month; 3 months
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Change in cognitive function from baseline to each post-treatment time point, assessed using the Montreal Cognitive Assessment (MoCA).
The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function.
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Baseline; 1 month; 3 months
|
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Change in Cognitive Function (Mini-Mental State Examination [MMSE])
時間枠：Baseline; 1 month; 3 months
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Change in cognitive function from baseline to each post-treatment time point, assessed using the Mini-Mental State Examination (MMSE).
The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive function.
|
Baseline; 1 month; 3 months
|
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Change in EEG Alpha Band Power
時間枠：Baseline; 1 month; 3 months
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Change in electroencephalogram (EEG) alpha band power (8-12 Hz) from baseline to each post-treatment time point.
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Baseline; 1 month; 3 months
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Change in Motor Evoked Potential (MEP) Amplitude
時間枠：Baseline; 1 month; 3 months
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Change in motor evoked potential (MEP) amplitude from baseline to each post-treatment time point, measured using transcranial magnetic stimulation.
MEP amplitude is measured in millivolts (mV), with higher values indicating greater corticospinal excitability.
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Baseline; 1 month; 3 months
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Change in Functional Connectivity (fMRI)
時間枠：Baseline; 3 months
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Change in functional connectivity between predefined brain regions from baseline to post-treatment, assessed using functional magnetic resonance imaging (fMRI).
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Baseline; 3 months
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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
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12月15日
一次修了 (推定)
2027年3月15日
研究の完了 (推定)
2027年6月15日
試験登録日
最初に提出
2026年3月22日
QC基準を満たした最初の提出物
2026年8月17日
最初の投稿 (実際)
2026年8月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年3月1日
詳しくは
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