Neurofeedback treatment for Tourette Syndrome in adolescents
Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
This study is testing if a brain training method called neurofeedback can help teenagers with Tourette Syndrome reduce their tics and improve their daily life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 10 Years to 16 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05558566 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves adolescents aged 10-16 with Tourette Syndrome or chronic tic disorder, who are randomized to receive neurofeedback targeting the supplementary motor area or a control region using real-time fMRI. Participants will undergo three neurofeedback sessions, where they will learn to up-regulate or down-regulate brain activity while receiving visual feedback. The goal is to assess the effectiveness of neurofeedback in reducing tic severity and improving overall functioning. The study aims to provide insights into the neural mechanisms underlying Tourette Syndrome and the potential for neurofeedback as a therapeutic intervention.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-16 with a diagnosis of Tourette Syndrome or chronic tic disorder and stable medication treatment.
Not a fit: Patients with significant comorbid psychiatric disorders or those unable to participate in fMRI due to medical restrictions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a novel non-pharmacological treatment option for adolescents with Tourette Syndrome.
How similar studies have performed: While neurofeedback has been explored in various contexts, this specific approach targeting the supplementary motor area for Tourette Syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Boys and girls, 10 to 16 years of age * A current diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD), with active tics that can be executed without head movement, and a YGTSS score of at least 13 (for TS participants) or at least 12 (for CTD participants) * Currently stable medication treatment and no planned changes in medication for the duration of the study. * Family residence within 2 hours of Yale Medical Center with ability and willingness to attend assessment and fMRI visits. * Children and their parents are expected to be able to speak and understand spoken English in order to participate in a clinical assessment of TS and related psychopathology. * Subjects will be free of: 1) metal medical implants or braces, 2) pregnancy, and will have 3) a body weight of less than 250 lbs. and 4) no claustrophobia. Exclusion Criteria: * Intelligence quotient below 80 * Current diagnosis of autism spectrum disorder, bipolar or psychotic disorder or current suicidality * Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder * Recently initiated psychotherapy. Participation in the study will not be allowed within 8 weeks of the initiation of psychotherapy. Ongoing, concurrent psychotherapy (that was initiated at least 8 weeks previously) for the child will be allowed, but parents will be asked not to initiate any new psychotherapy for the child during the study * Subjects may also be excluded after the first MR scan if we are unable to localize the two regions in their brain that are used as targets for the active and control neurofeedback conditions.
Where this trial is running
New Haven, Connecticut
- Yale University School of Medicine — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Hampson, PhD — Yale University
- Study coordinator: Cheyenne Harris-Starling
- Email: cheyenne.harris-starling@yale.edu
- Phone: 203-737-6055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.