Tourette Syndrome in Adolescence
Conditions
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).
Detailed description
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.
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.
Sponsors
Yale University
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in symptoms after the intervention compared to baseline | Baseline, 4 days post-NF, 2 weeks post-NF, and 1 month post-NF | Symptom severity is assessed using the Yale Global Tic Severity Scale (YGTSS) before NF and at several time points in the month following the completion of NF training. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in control over activity in the SMA target region during NF compared to baseline | Baseline and during NF | Control over the SMA is computed as the difference in the blood-oxygenation-level-dependent (BOLD) signal in SMA during up-regulate compared to down-regulate blocks. This measure is computed both in the NF scans and in the control task scans prior to the start of NF. Improvement in control for each subject is the difference of these two (i.e., control during NF minus control during pre-intervention control task scans). |
Countries
United States
Contacts
CONTACTCheyenne Harris-Starling
CONTACTJitendra Awasti
PRINCIPAL_INVESTIGATORMichelle Hampson, PhD
Yale University
Outcome results
None listed