Actively Recruiting

Phase Not Applicable
Age: 10Years - 16Years
All Genders
ID05558566

Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

Led by Yale University · Updated on 2025-08-06

64

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying adolescents aged 10 to 16 years with Tourette Syndrome or chronic tic disorder to compare two types of real-time fMRI neurofeedback targeting different brain regions. The trial aims to explore whether neurofeedback from the supplementary motor area (SMA) versus a control brain region can affect symptoms and brain activity related to these conditions. Participants undergo three training sessions involving fMRI neurofeedback. Each session includes six scans alternating between attempts to increase or decrease activity in the targeted brain region while watching a line graph showing their brain activity in real time. One group receives feedback from the SMA, while the control group receives feedback from a different brain region. During the study, participants will be assessed before the intervention, shortly after, and up to one month later to measure changes in symptoms and control over brain activity. Researchers will monitor symptom changes using standard scales and observe brain activity during neurofeedback. The study includes screening for eligibility, several neurofeedback training visits, and follow-up assessments to track progress and safety over time.

CONDITIONS

Brief Title

Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

Who Can Participate

Age: 10Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Boys and girls aged 10 to 16 years
  • Current diagnosis of Tourette Syndrome or chronic tic disorder with active tics that can be performed without head movement
  • YGTSS score of at least 13 for Tourette Syndrome or at least 12 for chronic tic disorder
  • Stable medication treatment with no planned changes during the study
  • Family residence within 2 hours of Yale Medical Center and ability to attend all assessment and fMRI visits
  • Ability of children and parents to speak and understand spoken English
  • No metal medical implants or braces
  • Not pregnant
  • Body weight less than 250 lbs
  • No claustrophobia
Not Eligible

You will not qualify if you...

  • Intelligence quotient below 80
  • Current diagnosis of autism spectrum disorder, bipolar disorder, psychotic disorder, or current suicidality
  • Significant medical conditions such as heart disease, hypertension, liver or renal failure, pulmonary disease, or seizure disorder
  • Psychotherapy initiated less than 8 weeks before the study; ongoing psychotherapy started at least 8 weeks before is allowed
  • Subjects may be excluded if target brain regions cannot be localized after the first MRI scan

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 2 weeks

Participants undergo three fMRI neurofeedback sessions to train control over brain activity in target regions, receiving feedback via a line graph during scans.

3 visits (in-person) with six neurofeedback scans per session

Follow-up

Duration - 1 month

Participants are assessed for symptom changes and control over brain activity at multiple timepoints after the neurofeedback sessions.

3 visits (in-person) at 4 days, 2 weeks, and 1 month post-treatment

Trial Site Locations

Total: 1 location

1

Yale University School of Medicine

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

C

Cheyenne Harris-Starling

J

Jitendra Awasti

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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