Tourette Syndrome Clinical Trial
Official title:
Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome
NCT number | NCT03642951 |
Other study ID # | 14050210 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | June 2022 |
Verified date | January 2022 |
Source | Children's Mercy Hospital Kansas City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 20 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City | Cornell University, The Methodist Hospital Research Institute |
United States,
Robertson MM, Eapen V, Cavanna AE. The international prevalence, epidemiology, and clinical phenomenology of Tourette syndrome: a cross-cultural perspective. J Psychosom Res. 2009 Dec;67(6):475-83. doi: 10.1016/j.jpsychores.2009.07.010. Review. — View Citation
Rossini PM, Rossi S. Transcranial magnetic stimulation: diagnostic, therapeutic, and research potential. Neurology. 2007 Feb 13;68(7):484-8. Review. — View Citation
Termine C, Selvini C, Rossi G, Balottin U. Emerging treatment strategies in Tourette syndrome: what's in the pipeline? Int Rev Neurobiol. 2013;112:445-80. doi: 10.1016/B978-0-12-411546-0.00015-9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in tic severity from baseline to 2 months post-treatment | The investigators will assess reduction in tics with the Yale Global Tic Severity Scale. It is a rating that is based on a clinician-rated, semistructured interview that begins with a systematic inquiry of tic symptoms in the preceding week. Five index scores are obtained: Total Motor Tic Score, Total Phonic Tic Score, Total Tic Score, Overall Impairment Rating, and Global Severity Score. The Total Motor Tic Score is derived by adding the five motor tics items (range = 0-25); the Total Phonic Tic Score is derived by adding the five phonic tics items (range = 0-25). The Total Tic Score is a summation of the Total Motor Tic and Total Phonic Tic Scores. The Overall Impairment Rating is rated on a 50-point scale anchored by 0 (No impairment) and 50 (Severe impairment). Finally, the Global Severity Score is a summation of the Total Motor Tic Score, Total Phonic Tic Score, and Overall Impairment Rating (range = 0-100). A higher score represents a worse outcome. | Day of first treatment session, End of weeks 1 and 2, as well as 1 month and 2 months after treatment | |
Secondary | Change in ADHD symptoms from baseline to two months post-treatment | The investigators will assess if treatment had any effect on ADHD symptoms using the Vanderbilt ADHD Parent Rating Scale. This validated scale consists of 49 questions regarding frequency of behaviors and 2 about performance. Predominately inattentive subtype (6 of 9 behaviors), (scores of 2 or 3 are positive) on items 1-9, and a performance problem (scores of 1 or 2) in any item in the performance section. Predominately hyperactive/Impulsive subtype requires 6 of 9 behaviors (scores of 2 or 3 are positive) on items 10-18 and a problem (1 or 2) in any item in the performance section. The Combined Subtype requires the above criteria on both inattention and hyperactivity/impulsivity. |
Day of first treatment session, End of weeks 1 and 2, as well as 1 month and 2 months after treatment | |
Secondary | Change in OCD symptoms from baseline to two months post-treatment | The investigators will assess if treatment had any effect on OCD symptoms using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The Y-BOCS is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. This scale is useful in tracking OCD symptoms at intake and during/after treatment. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted. Total scores can be split into five categories, based on severity of symptoms. Under 7 are likely to be subclinical, 8-15 are likely to have a mild case of OCD, 16-23 are likely to have a moderate case of OCD, 24-31 are likely to have a severe case of OCD, 32-40 are likely to have an extreme case of OCD. |
Day of first treatment session, End of weeks 1 and 2, as well as 1 month and 2 months after treatment |
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