Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents: A Randomized Controlled Clinical Trial
The objective of this trial is to evaluate the effect of transcutaneous auricular vagus nerve stimulation compared to sham stimulation in improving chronic tic disorder or Tourette's syndrome in children and adolescents.
調査の概要
状態
詳細な説明
Participants will be randomly assigned to receive transcutaneous auricular vagus nerve stimulation or sham stimulation. Both interventions will be administered 5 times per week for 8 weeks. Study outcomes will be evaluated at baseline and at weeks 4, 8, and 12.
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:Simeng Wang, PHD
- 電話番号:8618811022134
- メール:18811022134@163.com
研究連絡先のバックアップ
- 名前:Zhiyi Xiong, PHD
- 電話番号:8618811022104
- メール:zhiyixiong@foxmail.com
研究場所
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Zhejiang
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Hangzhou、Zhejiang、中国、310000
- The first Affiliated Hospital of Zhejiang Chinese Medical University (FirstZhejiangCMU)
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コンタクト:
- Simeng Wang, PHD
- 電話番号:8618811022134
- メール:18811022134@163.com
-
コンタクト:
- Zhiyi Xiong, PHD
- 電話番号:8618811022104
- メール:zhiyixiong@foxmail.com
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主任研究者:
- Simeng Wang, PHD
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
- Meets the DSM-5 diagnostic criteria for Tourette syndrome or chronic motor or vocal tic disorder;
- Age ≥6 and <18 years;
- YGTSS-TTS >15, or >10 for participants with motor tics or vocal tics only;
- If the participant is taking medication at enrollment, the medication regimen and dosage must have been stable for at least 4 weeks, with no planned changes in medication or dosage during the study;
- Has not received any non-pharmacological treatment for tics (e.g., acupuncture, transcranial magnetic stimulation, deep brain stimulation) within the preceding 8 weeks;
- Provides written informed consent.
Exclusion Criteria
- Mental or cognitive disability that would preclude participation in the study;
- Ear skin lesions, such as infection or eczema;
- An implanted cardiac pacemaker or other electronic medical device;
- Severe physical diseases, such as coronary heart disease, malignancy, or renal failure;
- Current participation in another clinical trial.
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:Transcutaneous auricular vagus nerve stimulation
Participants will receive transcutaneous auricular vagus nerve stimulation five times per week for eight consecutive weeks. |
Participants in the transcutaneous auricular vagus nerve stimulation group will receive stimulation at auricular acupoints located within the distribution area of the vagus nerve. A Hwato SDZ-II B electroacupuncture apparatus will be employed, with the two connecting clips of the same output lead attached to the acupoints on the same side. Disperse-dense wave stimulation will be applied, with the intensity adjusted according to the patient's tolerance, and each session will last 30 minutes. |
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偽コンパレータ:Sham stimulation
Participants will receive sham stimulation five times per week for eight consecutive weeks. |
Participants in the sham group will receive electrical stimulation at auricular acupoints located outside the distribution area of the vagus nerve, with a current intensity of 0.1 mA. All other procedures will be identical to those of the treatment group. |
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 |
|---|---|---|
|
The Yale Global Tic Severity Scale Total Tic Score
時間枠:Week 8 (post treatment).
|
The Yale Global Tic Severity Scale (YGTSS) is a clinician-rated instrument designed to evaluate the severity of motor tics, phonic tics, and overall impairment over the preceding week. Motor and vocal tics are rated independently across five dimensions (number, frequency, intensity, complexity, and interference; range 0-5 each), and the dimension scores are summed to yield separate Motor and Vocal Tic scores (range 0-25 each) as well as a combined YGTSS Total Tic Score (range 0-50), with higher scores indicating greater tic severity. The YGTSS Impairment Rating captures tic-related distress and functional impact (range 0-50). The YGTSS Total Tic Score and the YGTSS Impairment Rating are summed to produce a YGTSS total score (range 0-100), with higher scores indicating greater overall severity. |
Week 8 (post treatment).
|
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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The Yale Global Tic Severity Scale Total Score
時間枠:Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
|
The Yale Global Tic Severity Scale (YGTSS) is a clinician-rated instrument assessing motor tics, vocal tics, and impairment over the preceding week. Motor and vocal tics are each rated on five dimensions (number, frequency, intensity, complexity, and interference; 0-5 each), yielding Motor and Vocal Tic scores (0-25 each) and a YGTSS Total Tic Score (0-50). The YGTSS Impairment (0-50) is added to the YGTSS Total Tic Score to produce a YGTSS Total Score (0-100), with higher scores indicating greater severity. |
Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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Children's Yale-Brown Obsessive Compulsive Scale
時間枠:Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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The Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) will be used to assess the severity of obsessive-compulsive symptoms in children and adolescents. The total score of CY-BOCS ranges from 0 to 40, with higher scores indicate greater symptom severity. |
Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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Swanson, Nolan, and Pelham-IV-18
時間枠:Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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The Swanson, Nolan, and Pelham Rating Scale version IV (SNAP-IV-18) will be used to assess symptoms of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. The total score of SNAP-IV-18 ranges from 0 to 54, with higher scores indicate more severe symptoms. |
Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life
時間枠:Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
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The Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life (C&A-GTS-QOL) questionnaire will be used to assess health-related quality of life in children and adolescents with Tourette syndrome. The total score of C&A-GTS-QOL is typically transformed to a 0-100 scale, with higher scores indicating greater impairment and poorer quality of life. |
Week 0 (baseline), week 4, week 8 (post treatment), week 12 (follow-up).
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adverse Events
時間枠:Week 0 (baseline) to week 12.
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An adverse event is any unexpected symptom, sign, or health condition occurring after initiation of study treatment, which may or may not be related to the study intervention. Pre-existing health conditions or diseases will only be considered as adverse events if they worsen after enrollment. |
Week 0 (baseline) to week 12.
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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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- FirstZhejiangCMU
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
Deidentified participant data will be available from the study PI upon reasonable request after publication.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
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
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