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

February 16, 2018 updated by: Yu Jinna, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Guang'an Men Hospital, China Academy of Chinese Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Plum-blossom needle group
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
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.
Other Names:
  • acupuncture
  • plum-blossom needle
ACTIVE_COMPARATOR: HRT group
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
HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of YGTSS score from baseline at the 12th week
Time Frame: baseline, week 12
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
Time Frame: baseline, week 4, week 8, week 24.
this outcome will be measured by the Yale Global Tic Severity Scale.
baseline, week 4, week 8, week 24.
CGI score
Time Frame: week 4, week 8, week 12, week 24.
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
Time Frame: baseline, week 12, week 24.
this outcome will be measured by the Children and Adolescents' Quality of Life Scale (CAQOL)
baseline, week 12, week 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Study Chair: Jinna Yu, Ph.D, Guang'an Men Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (ESTIMATE)

March 31, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014S298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We haven't get consent from patients to share their individual data with other researchers.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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