Tourette SyndromeNCT02403258
The Effect and Safety of Plum-blossom Needle for Tourette Syndrome
A study testing Plum-blossom needle group and HRT group in people with Tourette Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
To evaluate the effect and safety of plum-blossom needle for Tourette syndrome. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Plum-blossom needle group and HRT group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'an Men Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
About this study
Official title: 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.
Read the 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.
- Conditions
- Tourette Syndrome
- Being tested
- Plum-blossom needle group, HRT group
- Keywords
- acupuncture, plum-blossom needle, tourette syndrome, randomized controlled trial
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plum-blossom needle groupOther
Also called acupuncture, plum-blossom needle
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 groupBehavioural
HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management.
| Study group | Role | What they receive |
|---|---|---|
| Plum-blossom needle group | Experimental | 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). Receives: Other: Plum-blossom needle group |
| HRT group | Active comparator | 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. Receives: Behavioral: HRT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, week 12
Secondary outcomes (3)
change of YGTSS score from baseline at other point times
this outcome will be measured by the Yale Global Tic Severity Scale.
Measured: baseline, week 4, week 8, week 24.
CGI score
this outcome will be measured by the TS Clinical Global Impression Scale (CGI).
Measured: 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)
Measured: baseline, week 12, week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Jinna, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jinna Yu, Ph.D, Study chair, Guang'an Men Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403258
- Sponsor's protocol ID
- 2014S298
- Status last verified
- Feb 2018
- First submitted
- 26 Mar 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: We haven't get consent from patients to share their individual data with other researchers.
Publications
Yu J, Ye Y, Li S, Liu J, Zhai Y, Zhang M, Liu Z. The effectiveness and safety of plum-blossom needle therapy for Tourette syndrome: study protocol for a randomized controlled trial. Trials. 2015 Jul 29;16:320. doi: 10.1186/s13063-015-0873-0.
PubMed 26220439
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Plum-blossom Needle for Tourette Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02403258
- Acronym / sponsor ID
- 2014S298
- Conditions
- Tourette Syndrome
- Keywords
- acupuncture, plum-blossom needle, tourette syndrome, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect and safety of plum-blossom needle for Tourette syndrome.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plum-blossom needle group | Experimental | Other: Plum-blossom needle groupPatients 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). |
| HRT group | Active comparator | Behavioral: HRT groupPatients 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plum-blossom needle groupAlso: acupuncture, plum-blossom needlePlum-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 | Plum-blossom needle group |
| HRT groupHRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management. | Behavioural | HRT group |
Primary outcome
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).
3 secondary outcomes
change of YGTSS score from baseline at other point times
Time frame: baseline, week 4, week 8, week 24.
CGI score
Time frame: week 4, week 8, week 12, week 24.
change of quality of life from baseline
Time frame: baseline, week 12, week 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 26220439Yu J, Ye Y, Li S, Liu J, Zhai Y, Zhang M, Liu Z. The effectiveness and safety of plum-blossom needle therapy for Tourette syndrome: study protocol for a randomized controlled trial. Trials. 2015 Jul 29;16:320. doi: 10.1186/s13063-015-0873-0.
- Individual participant dataSharing planned: Undecided. We haven't get consent from patients to share their individual data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinna Yu, Ph.D study chair
Guang'an Men Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plum-blossom needle group and HRT group in people with Tourette Syndrome, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinna Yu, Ph.D (8610-010-88001413, 546872837@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of YGTSS score from baseline at the 12th week (time frame: baseline, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02403258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.