An interventional study of traditional stimulation site continuous theta burst stimulation (cTBS) and precise stimulation site cTBS in Tic Disorders and Tourette Syndrome, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 2 sites in China. Open to participants aged 6 Years to 20 Years. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
continuous theta burst stimulation (cTBS) is a safe and effective device for Gilles de la Tourette's syndrome treatment. GPi is an agreed curative target of deep brain stimulation. GPi-based functional connectivity peak voxel in the SMA can be the cTBS target.
Tic disorder is a common neuropsychiatric disorder in children and adolescents. Medication is not effective and has side effect. Exploring new treatment methods is one of the research pathway of this disease.Continuous theta burst stimulation (cTBS) is relatively safe and effective, and its efficacy in psychiatric diseases has been gradually recognized. However, the results of current researches of tic disorder treatment are varied, and the evaluation method is relatively single. This project intends to adopt fmri-guided stimulation target and navigated cTBS to intervene patients with tics and explore individualized cTBS treatment parameters of tics, including stimulation frequency, intensity, type, time and stimulation target. Previous studies for deep brain stimulation reported that the medial globus pallidus (GPi) showed an obvious curative effect. And a deep brain area can be modulated indirectly by a superficial target via functional connectivity. Therefore, the present study attempts to stimulate the superficial target in supplementary motor area (SMA), lateral motor area (M1) which functionally connected with GPi or thalamus since the thalamus also a commonly reported abnormal brain area of Tic. Combined with clinical symptoms and neuroimaging, the therapeutic effect of cTBS in children with tic disorder was comprehensively evaluated in order to provide a new therapeutic method and a better therapeutic effect for the disease.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's enrollment of 95 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Compared within Tourette Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tic Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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arm: experimental: performing cTBS to tic patients for continuous 5 days ,3 times for a day (0 minute ,15 minute ,60 minute). The stimulation site include left supplementary motor area, right supplementary motor area, left primary motor area, right primary motor area , left superior parietal lobule, right superior parietal lobule. Determination of stimulation target is a common method of determination in previous studies. For example the vertex (Cz) was measured for each patient and the SMA defined at 15% of the distance between inion and nasion anterior to Cz on the sagittal midline.
Device: traditional stimulation site continuous theta burst stimulation (cTBS)
arm: experimental: performing cTBS to tic patients for 5 days ,3 times for a day (0 minute ,15 minute ,60 minute). The stimulation site include left supplementary motor area, right supplementary motor area, left primary motor area, right primary motor area , left superior parietal lobule, right superior parietal lobule. The stimulation target is determined by the resting-state functional connectivity, which is robust functional connectivity with the GPi or Thalamus.
Device: precise stimulation site cTBS
before cTBS treatment, MRI was used to confirm the stimulation site
before cTBS treatment, rs-fMRI was used to confirm the stimulation site
Yale Global Tic Severity Scale score
to evaluate clinical change
Time frame: 5 days
fMRI
local neural activity; functional connectivity
Time frame: 1 day, 5 days
Plan to share: No
Ran from Jun 2018 to primary completion in Oct 2019, 16 months.
Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's 16 months is below that.
Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →