The Effect and Safety of Plum-blossom Needle for Tourette Syndrome

Study Overview
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Brief Summary
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To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.

Detailed Description
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This is a randomized, controlled trial with two parallel arms. A total of 60 patients will be randomly allocated into the plum-blossom needle group (n=30) and the habit reversal training (HRT) group (n=30). 12-week treatment will be given to all patients of each group, follow-up will be made at the 12th week after treatment. The primary outcome measure will be the mean change from baseline in the total tic score on the Yale Global Tic Severity Scale (YGTSS) at the 12th week. Secondary outcome measures will include the mean changes in score of YGTSS, TS Clinical Global Impression Scale (CGI) and the Children and Adolescents' Quality of Life Scale from baseline at other time. Safety will also be evaluated.

Official Title
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The Effect and Safety of Plum-blossom Needle for Tourette Syndrome: a Randomized Controlled Trial

Conditions
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Tourette Syndrome

Intervention / Treatment
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* Other: Plum-blossom needle group
* Behavioral: HRT group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-IV) for TS. Aged 7 to 18. Agree to participate in the trial and sign written informed consent by both guardians and subjects. Exclusion Criteria: Having severe problem in heart, liver or kidney, or having hyperthyroidism. After evaluated by psychiatrists based on the Kiddie-Sads-Present and Lifetime Version, those who are associated with co-morbid conditions such as mental retardation, pervasive developmental disorder, schizophrenia, mania episode, bipolar disorder, anxiety and depression and specific learning disorder will be excluded. Tics symptoms caused by some drugs. Currently receiving any other form of pharmacological or non-pharmacological treatment for their Tourette syndrome. Patients with a history of psychotropic substance or alcohol use during the 3 months preceding screening. Patients with a history of nonresponsiveness to HRT or participating in another clinical trial.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plum-blossom needle group<br>Patients randomized into this group will receive plum-blossom needle as treatment. DU 20, DU 16, GB 20, EX-HN5, BL 15, BL 18, BL 23 will be selected as acupoints. Each point will be tapped gently one by one by plum blossom needle until the skin get slightly redness. The treatments will be given two sessions per week, consistently for 12weeks (24 sessions in all). | Other: Plum-blossom needle group<br>* Plum-blossom needle is a method of shallow insertion with multiple needles. It is made of five or seven stainless steel needles arranged in a pattern like the shape of plum blossom, thus named as 'plum-blossom needle'. Plum-blossom needle treat diseases by tapping specific skin areas or acupoints according to different illness based on the theory of meridian.<br>* Other names: plum-blossom needle;|
| Active Comparator: HRT group<br>Patients randomized into this group will receive habit reversal training (HRT) as treatment. Habit reversal training will consist of the following 4 parts: (1) self-monitoring, (2) competing responses, (3) relaxation training and (4) contingency management. The training will be given weekly in the 12 weeks (totally 12 sessions) by a special rehabilitation therapist, first two sessions 1.5 h, and remaining sessions 1 h for each treatment. | Behavioral: HRT group<br>* HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of YGTSS score from baseline at the 12th week | the symptom scale used in this trial will be the Yale Global Tic Severity Scale. (YGTSS). | baseline, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of YGTSS score from baseline at other point times | this outcome will be measured by the Yale Global Tic Severity Scale. | baseline, week 4, week 8, week 24. | 
| CGI score | this outcome will be measured by the TS Clinical Global Impression Scale (CGI). | week 4, week 8, week 12, week 24. | 
| change of quality of life from baseline | this outcome will be measured by the Children and Adolescents' Quality of Life Scale (CAQOL) | baseline, week 12, week 24. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, plum-blossom needle, tourette syndrome, randomized controlled trial