Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children … (NCT03642951) | Clinical Trial Compass
WithdrawnNot Applicable
Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome
Stopped: Low Enrollment
United States0Started 2019-07-01
Plain-language summary
The investigators are investigating the effectiveness of a wearable multisite transcranial magnetic stimulation (mTMS) device that can deliver stimuli at multiple cortical sites simultaneously or sequentially for the treatment of Tourette Syndrome.
Who can participate
Age range8 Years – 20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients between the ages of 8 and 20 years old,
* A clinical diagnosis of TS as defined by the DSM V
* YGTSS score of 13 or more (performed at Visit 1).
* Patients with the following comorbidities: OCD, ADHD and anxiety disorders (as defined by the DSM V) will be allowed in the study. This will be assessed during Visit 1.
* The patients may be on medications for the treatment of TS or allowed comorbidities provided the medication regimen is stable for six weeks prior to inclusion in the study and remains unchanged for the 10 weeks that the study will last.
Exclusion Criteria:
* Any history of neurological, or psychiatric disorders including epilepsy and autism spectrum disorder, other than other than the allowed comorbidities (see above).
* An IQ less than 80, this will be assessed during Visit 1.
* Any changes in medications prescribed for the treatment of TS or allowed comorbidities six weeks prior to inclusion in the study or at any time during the study.
* The presence of metal implants or metallic devices in the head
* Any history of drug or alcohol abuse
* Any medication changes during the six weeks preceding enrollment or at any time during the 10-week course of the study
What they're measuring
1
Change in tic severity from baseline to 2 months post-treatment
Timeframe: Day of first treatment session, End of weeks 1 and 2, as well as 1 month and 2 months after treatment