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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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