Recruiting

Neurofeedback

Sponsor:

Yale University

Code:

NCT05558566

Conditions

Tourette Syndrome in Adolescence

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

Interventions

Neurofeedback from the SMA

Neurofeedback from control region

Study Details

Brief summary:

This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fMRI) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fMRI neurofeedback (NF) from a control region (for the control intervention).

Conditions

Tourette Syndrome in Adolescence

Study ID

NCT05558566

Start date

Nov 1, 2022

Status verified date

Jun, 2026

Completion date

Jan 20, 2027

Anticipated

Primary completion date

Dec 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 16

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neurofeedback from the SMA

active comparator: Neurofeedback from control region

Interventions

Neurofeedback from the SMA

Feedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal

Neurofeedback from control region

Feedback is provided regarding activity in a control region and participant attempts to control activity in that region using the feedback as a training signal.

Primary outcome measure

  • Change in symptoms after the intervention compared to baseline [ Time Frame: Baseline, 4 days post-NF, 2 weeks post-NF, and 1 month post-NF ]

Central Contacts and Locations

Central contacts

Cheyenne Harris-Starling

203-737-6055cheyenne.harris-starling@yale.edu

Jitendra Awasti

203-737-6055jitendra.awasti@yale.edu

Locations

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

Principal Investigator:

Michelle Hampson, PhD

More Information

Sponsor

Yale University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-09.