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

Tourette Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02403258
• Other study ID #: 2014S298
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2015
• Last updated: February 16, 2018
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jinna Yu, Ph.D
• Phone: 8610-010-88001413
• Email: 546872837[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Other:
• Plum-blossom needle group
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.

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

Locations

Country	Name	City	State
China	Guang'an Men Hospital, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	CGI score	this outcome will be measured by the TS Clinical Global Impression Scale (CGI).	week 4, week 8, week 12, week 24.
Secondary	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.