Tourette SyndromePhase 1NCT01440023
Developing Cognitive Training for Tourette Syndrome
A Phase 1 study testing Comprehensive Behavioral Intervention for Tics (CBIT) and Computerized Response Inhibition Training in people with Tourette Syndrome and Chronic Tic Disorders, run by University of Wisconsin, Milwaukee at 1 site in United States.
Trial summary
Many researchers suspect that individuals with Tourette Syndrome (TS) may have a poor cognitive ability (i.e., response inhibition; RI) that is essential to inhibit inappropriate response such as vocal or motor tics. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Tourette Syndrome, Chronic Tic Disorders
- What is being tested?
- Comprehensive Behavioral Intervention for Tics (CBIT) and Computerized Response Inhibition Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Dec 2014
- Phase
- Phase 1
- 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 9 and 17
- a diagnosis of TS or chronic tic disorder on the structured diagnostic interview
- moderate to severe levels of tic symptoms (YGTSS total score > 13 for TS, or > 9 for CTD), and (d) IQ > 80.
Who cannot join
- current substance abuse or dependence
- current or past psychotic disorder, bipolar disorder, or schizophrenia
- 4 or more previous sessions of behavioral treatments for tic
- significant suicidal ideation and/or attempts within the past 3 months
- any recent (in the previous month) or planned change in medication for tic symptoms.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Psychology Clinic, University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, 53211
About this study
Official title: Developing Effective Response Inhibition Training for Symptom Relief in Tourette Syndrome
Many researchers suspect that individuals with Tourette Syndrome (TS) may have a poor cognitive ability (i.e., response inhibition; RI) that is essential to inhibit inappropriate response such as vocal or motor tics. The investigators aim to test whether a well-established behavior therapy for TS can be improved by increasing the individual's RI capabilities. To this end, 20 children will be randomly assigned to behavior therapy with computer-based RI training or behavior therapy with placebo computer-based cognitive training. The investigators will test the hypothesis that computer-based RI training can be a useful addition to the well-established behavior therapy to enhance its therapeutic effect.
Read the detailed description
The current research seeks to examine the feasibility of using a computer-based RI training program as an adjunctive intervention for the Comprehensive Behavioral Intervention for Tics (CBIT). Our central hypothesis is that cognitive training designed to enhance RI will potentiate treatment outcomes of CBIT. To this end, the investigators will conduct a two-arm placebo-controlled double-blind trial, in which 20 children with TS will be randomly assigned to CBIT with computerized RI training (CBIT+RIT; n=10) or CBIT with placebo computer training (CBIT +PLT; n=10). CBIT consists of eight weekly sessions that present awareness training, competing response training, relaxation training and functional contingency management in a manualized format. The adjunctive computer training (RIT or PLT) will be delivered during the first 4 weeks of CBIT/HRT (i.e. 8 twice-weekly 40-min sessions). Tic symptoms and RI capabilities will be assessed at baseline, mid-treatment, post-treatment, and 1 month follow-up. This project is expected to increase our understanding about the nature of response inhibition deficits in TS and generate knowledge that will guide the development of effective cognitive interventions for TS.
- Conditions
- Tourette Syndrome, Chronic Tic Disorders
- Being tested
- Comprehensive Behavioral Intervention for Tics (CBIT), Computerized Response Inhibition Training, Computerized Placebo Cognitive Training
- Keywords
- tic disorder, tourette syndrome, habit reversal, response inhibition, cognitive retraining
- Medical subject headings
- Tourette Syndrome, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Behavioral Intervention for Tics (CBIT)Behavioural
Also called Habit Reversal for Tourette Syndrome
CBIT is an 8 session treatment protocol held over 10 weeks. Its core components are implemented across the various therapy sessions. These core components include habit reversal training (HRT), functional assessment/function-based interventions, and a behavioral reward program for the child.
Computerized Response Inhibition TrainingBehavioural
Twice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities.
Computerized Placebo Cognitive TrainingBehavioural
Twice-weekly 45 minute computerized sessions for placebo cognitive training, which has been designed to be irrelevant for response inhibition capabilities.
| Study group | Role | What they receive |
|---|---|---|
| CBIT + Response Inhibition Training | Experimental | CBIT is an 8 session treatment protocol held over 10 weeks. In CBIT, core components are implemented across the various therapy sessions. These core components include habit reversal training (HRT), functional assessment/function-based interventions, and a behavioral reward program for the child. Each core component is briefly described below. HRT/CBIT involves three components, awareness training, competing response training, and social support training (Woods, Twohig, Roloff, \& Flessner, 2003). For this condition, CBIT will be combined with adjunctive computerized response inhibition training, which will be delivered over the first 4 weeks of the CBIT treatment. Receives: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT); Behavioral: Computerized Response Inhibition Training |
| Experimental: CBIT + Placebo Computer Training | Placebo comparator | In this condition, participants receive the same package of CBIT treatment, which consists of awareness training, competing response training, and social support training (Woods, Twohig, Roloff, \& Flessner, 2003). Additionally, the standard CBIT treatment is combined with computer-based placebo cognitive training that is irrelevant to the target cognitive ability (i.e., response inhibition). During the first 4 weeks of the CBIT treatment, participants will receive 8 sessions of placebo cognitive training. Receives: Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT); Behavioral: Computerized Placebo Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on the Yale Global Tic Severity Scale (YGTSS) across baseline, 4-week, 8-week, and 12 week assessments. during and after the treatment from baseline
The YGTSS is a well-validated instrument that produces severity ratings for motor and vocal tics, impairment caused by the tics, and an overall severity score of tic symptoms.
Measured: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)
Secondary outcomes (1)
Change in scores on the Clinical Global Impression Severity and Improvement (CGI-S and CGI-I) across baseline, 4-week, 8-week, and 12 week assessments.
The CGI-S and CGI-I are clinicianadministered rating scales that have been widely used in treatment outcome research for over 25 years. The current research will use the CGI scale to evaluate the overall severity and improvement in tic symptoms.
Measured: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Milwaukee
- Sponsor type
- University, hospital or other
- Collaborators
- Tourette Association of America
- Responsible party
- Principal investigator, Han Joo Lee, University of Wisconsin, Milwaukee
- Investigators
- Han Joo Lee, Ph.D., Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440023
- Sponsor's protocol ID
- TSA-2011-Lee
- Other IDs
- TSA
- Status last verified
- Jan 2015
- First submitted
- 2 Sep 2011
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Effective Response Inhibition Training for Symptom Relief in Tourette Syndrome
- ClinicalTrials.gov ID
- NCT01440023
- Acronym / sponsor ID
- TSA-2011-Lee
- Conditions
- Tourette Syndrome, Chronic Tic Disorders
- Keywords
- tic disorder, tourette syndrome, habit reversal, response inhibition, cognitive retraining
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MilwaukeeUniversity, hospital or other
- Collaborators
- Tourette Association of America
- Study start
- Aug 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Sep 2011 (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.
Many researchers suspect that individuals with Tourette Syndrome (TS) may have a poor cognitive ability (i.e., response inhibition; RI) that is essential to inhibit inappropriate response such as vocal or motor tics. The investigators aim to test whether a well-established behavior therapy for TS can be improved by increasing the individual's RI capabilities. To this end, 20 children will be randomly assigned to behavior therapy with computer-based RI training or behavior therapy with placebo computer-based cognitive training. The investigators will test the hypothesis that computer-based RI training can be a useful addition to the well-established behavior therapy to enhance its therapeutic effect.
Detailed description
The current research seeks to examine the feasibility of using a computer-based RI training program as an adjunctive intervention for the Comprehensive Behavioral Intervention for Tics (CBIT). Our central hypothesis is that cognitive training designed to enhance RI will potentiate treatment outcomes of CBIT. To this end, the investigators will conduct a two-arm placebo-controlled double-blind trial, in which 20 children with TS will be randomly assigned to CBIT with computerized RI training (CBIT+RIT; n=10) or CBIT with placebo computer training (CBIT +PLT; n=10). CBIT consists of eight weekly sessions that present awareness training, competing response training, relaxation training and functional contingency management in a manualized format. The adjunctive computer training (RIT or PLT) will be delivered during the first 4 weeks of CBIT/HRT (i.e. 8 twice-weekly 40-min sessions). Tic symptoms and RI capabilities will be assessed at baseline, mid-treatment, post-treatment, and 1 month follow-up. This project is expected to increase our understanding about the nature of response inhibition deficits in TS and generate knowledge that will guide the development of effective cognitive interventions for TS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBIT + Response Inhibition Training | Experimental | Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT), Behavioral: Computerized Response Inhibition TrainingCBIT is an 8 session treatment protocol held over 10 weeks. In CBIT, core components are implemented across the various therapy sessions. These core components include habit reversal training (HRT), functional assessment/function-based interventions, and a behavioral reward program for the child. Each core component is briefly described below. HRT/CBIT involves three components, awareness training, competing response training, and social support training (Woods, Twohig, Roloff, \& Flessner, 2003). For this condition, CBIT will be combined with adjunctive computerized response inhibition training, which will be delivered over the first 4 weeks of the CBIT treatment. |
| Experimental: CBIT + Placebo Computer Training | Placebo comparator | Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT), Behavioral: Computerized Placebo Cognitive TrainingIn this condition, participants receive the same package of CBIT treatment, which consists of awareness training, competing response training, and social support training (Woods, Twohig, Roloff, \& Flessner, 2003). Additionally, the standard CBIT treatment is combined with computer-based placebo cognitive training that is irrelevant to the target cognitive ability (i.e., response inhibition). During the first 4 weeks of the CBIT treatment, participants will receive 8 sessions of placebo cognitive training. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age between 9 and 17
- a diagnosis of TS or chronic tic disorder on the structured diagnostic interview
- moderate to severe levels of tic symptoms (YGTSS total score > 13 for TS, or > 9 for CTD), and (d) IQ > 80.
Key exclusion criteria (5 listed)
- current substance abuse or dependence
- current or past psychotic disorder, bipolar disorder, or schizophrenia
- 4 or more previous sessions of behavioral treatments for tic
- significant suicidal ideation and/or attempts within the past 3 months
- any recent (in the previous month) or planned change in medication for tic symptoms.
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 |
|---|---|---|
| Comprehensive Behavioral Intervention for Tics (CBIT)Also: Habit Reversal for Tourette SyndromeCBIT is an 8 session treatment protocol held over 10 weeks. Its core components are implemented across the various therapy sessions. These core components include habit reversal training (HRT), functional assessment/function-based interventions, and a behavioral reward program for the child. | Behavioural | CBIT + Response Inhibition Training, Experimental: CBIT + Placebo Computer Training |
| Computerized Response Inhibition TrainingTwice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities. | Behavioural | CBIT + Response Inhibition Training |
| Computerized Placebo Cognitive TrainingTwice-weekly 45 minute computerized sessions for placebo cognitive training, which has been designed to be irrelevant for response inhibition capabilities. | Behavioural | Experimental: CBIT + Placebo Computer Training |
Primary outcome
Change in scores on the Yale Global Tic Severity Scale (YGTSS) across baseline, 4-week, 8-week, and 12 week assessments. during and after the treatment from baseline
Time frame: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)
The YGTSS is a well-validated instrument that produces severity ratings for motor and vocal tics, impairment caused by the tics, and an overall severity score of tic symptoms.
1 secondary outcome
Change in scores on the Clinical Global Impression Severity and Improvement (CGI-S and CGI-I) across baseline, 4-week, 8-week, and 12 week assessments.
Time frame: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
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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.
Han Joo Lee, Ph.D. principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comprehensive Behavioral Intervention for Tics (CBIT) and Computerized Response Inhibition Training in people with Tourette Syndrome and Chronic Tic Disorders, run by University of Wisconsin, Milwaukee at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 15 Jan 2015. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on the Yale Global Tic Severity Scale (YGTSS) across baseline, 4-week, 8-week, and 12 week assessments. during and after the treatment from baseline (time frame: At baseline, 4 week (mid-treatment), 8 week (post-treatment), and 12 week (1-month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2015.