Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2027-01-20

Brief Summary

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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).

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Detailed Description

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The training portion of this study involves three fMRI NF sessions, with six NF scans per session. NF scans alternate between up-regulate and down-regulate blocks in which participants are cued to increase or decrease activity in the target region while receiving feedback on activity in the region at the bottom of the screen in the form of a line graph. The experimental group receives feedback from the supplementary motor area (SMA) and the control group receives feedback from a control region of the brain.

Conditions

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Tourette Syndrome in Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Neurofeedback from the SMA

Group Type EXPERIMENTAL

Neurofeedback from the SMA

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Neurofeedback from control region

Intervention Type OTHER

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.

Interventions

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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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No