RecruitingNot ApplicableNCT05558566

Neurofeedback From the Supplementary Motor Area for Tourette Syndrome


Sponsor

Yale University

Enrollment

64 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 10 YearsMax Age: 16 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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.

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Interventions

OTHERNeurofeedback 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

OTHERNeurofeedback 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.


Locations(1)

Yale University School of Medicine

New Haven, Connecticut, United States

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NCT05558566


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