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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences60 enrolled

Overview

To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tourette Syndrome

Interventions

Plum-blossom needle groupOTHER

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.

HRT groupBEHAVIORAL

HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management.

Eligibility

Sex: ALLMin age: 7 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Meeting the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association (DSM-IV) for TS. 2. Aged 7 to 18. 3. Agree to participate in the trial and sign written informed consent by both guardians and subjects. Exclusion Criteria: 1. Having severe problem in heart, liver or kidney, or having hyperthyroidism. 2. 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. 3. Tics symptoms caused by some drugs. 4. Currently receiving any other form of pharmacological or non-pharmacological treatment for their Tourette syndrome. 5. Patients with a history of psychotropic substance or alcohol use during the 3 months preceding screening. 6. Patients with a history of nonresponsiveness to HRT or participating in another clinical trial.

Locations (1)

Guang'an Men Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: baseline, week 12

Secondary Outcomes

change of YGTSS score from baseline at other point times

this outcome will be measured by the Yale Global Tic Severity Scale.

Time frame: baseline, week 4, week 8, week 24.

CGI score

this outcome will be measured by the TS Clinical Global Impression Scale (CGI).

Time frame: 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)

Time frame: baseline, week 12, week 24.

Central Contacts

Jinna Yu, Ph.D

CONTACT

8610-010-88001413 546872837@qq.com

Data from ClinicalTrials.gov

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