Tourette Syndrome Clinical Trial
Official title:
Behavior Therapy for Children With Chronic Tic Disorders
This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit reversal training (HRT) in treating chronic tic disorders (CTDs) in children and adolescents.
CTDs and Tourette syndrome are neurobehavioral disorders that are characterized by a
persistent pattern of motor and vocal tics. Tics are intermittent movements or sounds that
occur repeatedly. They can be either brief, rapid, and darting movements or more purposeful
movements, such as repetitively locking and unlocking a door. Vocal tics can be simple, as
in sniffing or grunting, or more complex, such as complete words or phrases. Tic disorders
can cause considerable distress in affected children, and can lead to social and academic
impairment. If left untreated, CTDs can last into adulthood. The standard treatment for
suppressing CTDs is medication; dopamine-blocking drugs are used most commonly. These
medications, however, are associated with a range of adverse effects that can result in poor
treatment compliance and premature treatment termination. Recent research suggests that HRT
may be an effective, lower risk treatment for CTDs. HRT is a behavioral treatment based on
increasing awareness of one's behaviors and replacing unwanted behaviors with less
bothersome ones. This study will determine the effectiveness of CBT with HRT in treating
CTDs in children and adolescents.
Participants in this double blind study will be randomly assigned to receive either CBT plus
HRT or standard care, which will consist of psychoeducation and supportive therapy. All
participants will partake in 8 sessions of their assigned therapy over the course of 10
weeks. After the initial 10 weeks, those who responded to treatment will report back to the
study site for 3 monthly booster sessions. Changes in tic severity, effects of the therapies
on overall functioning and quality of life, and possible predictors of treatment outcome
will be assessed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04851678 -
Longitudinal Impact of Stressors in Adults With Tourette Syndrome
|
||
Completed |
NCT02605902 -
Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
|
N/A | |
Completed |
NCT04007913 -
Incorporating teleCBIT Into a Hospital-Based Tic Program
|
N/A | |
Completed |
NCT02900144 -
Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)
|
N/A | |
Completed |
NCT02216474 -
Brain Stimulation in Movement Disorders
|
N/A | |
Completed |
NCT02256475 -
Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
|
Phase 1 | |
Completed |
NCT01329198 -
Brain Stimulation for the Treatment of Tourette Syndrome
|
N/A | |
Terminated |
NCT00952601 -
Pilot Study of the Modified Atkins Diet for Tourette Syndrome
|
Phase 1 | |
Enrolling by invitation |
NCT00355927 -
Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.
|
N/A | |
Completed |
NCT00206323 -
A Randomized, Placebo-controlled, Tourette Syndrome Study.
|
Phase 3 | |
Completed |
NCT00004376 -
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
|
Phase 3 | |
Completed |
NCT04498364 -
Extinction Learning in Adults With Tourette Syndrome
|
N/A | |
Completed |
NCT00755339 -
Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
|
||
Completed |
NCT03325010 -
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
|
Phase 2 | |
Not yet recruiting |
NCT06081348 -
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
|
Phase 2 | |
Completed |
NCT01719523 -
Open-Trial of EPI-743 for Adults With Tourette Syndrome
|
Phase 1 | |
Completed |
NCT01702077 -
Neurofeedback for Tourette Syndrome
|
N/A | |
Completed |
NCT00231985 -
Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder
|
Phase 2 | |
Completed |
NCT00206336 -
An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.
|
Phase 3 | |
Terminated |
NCT03732534 -
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
|
Phase 2 |