RECRUITING

Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

Quick Facts

Study Start:2022-11-01

Study Completion:2027-01-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05558566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 16 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Cheyenne Harris-Starling

CONTACT

203-737-6055

cheyenne.harris-starling@yale.edu

Jitendra Awasti

CONTACT

203-737-6055

jitendra.awasti@yale.edu

Principal Investigator

Michelle Hampson, PhD

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University School of Medicine

New Haven, Connecticut, 06520

United States

Collaborators and Investigators

Sponsor: Yale University

Michelle Hampson, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01

Study Completion Date2027-01-20

Study Record Updates

Study Start Date2022-11-01

Study Completion Date2027-01-20

Terms related to this study

Additional Relevant MeSH Terms

Tourette Syndrome in Adolescence