An interventional study of Accelerated deep iTBS and Accelerated Sham iTBS in Obsessive-Compulsive Disorder, sponsored by Pamukkale University. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by Pamukkale University · Not applicable, Interventional, and Treatment
H-coil high-frequency deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex (mPFC) and anterior cingulate cortex (ACC) has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder. At the same time, there are studies in the literature showing the effectiveness of intermittent theta burst stimulation application and the advantages of short treatment duration. However, there is no strong scientific evidence yet on the effectiveness and safety of iTBS (50 Hz) application with a double-cone coil in obsessive-compulsive disorder patients. The aim of this study is to evaluate the effectiveness of dTMS with ITBS protocol on the medial prefrontal cortex (mPFC) and anterior cingulate cortex (ACC) in OCD patients.
The current study aimed to investigate the effectiveness and safety of the ITBS protocol, which is applied to the mPFC and ACC for 5 sessions per day with a double-cone coil in treatment-resistant OCD patients. This study evaluated (I) the effectiveness of Itbs (50 Hz) stimulation of the mPFC and ACC with a double-cone coil and (II) the effectiveness of administering this protocol over 2 weeks rather than six weeks as approved by the FDA. Participants will be randomized into two parallel groups in a double-blind manner. In one group, ITBS (50 Hz) dTMS will be applied to mPFC and ACC, and in the other group, sham tms will be applied to the same regions. The application consists of a total of 50 sessions, 5 times a day. This application will last for a total of 10 days excluding weekends.
367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.
This study's planned enrollment of 30 is below the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.
Browse Compulsive Personality Disorder studies →Pamukkale University is the lead sponsor of 331 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
Accelerated dTMS on anterior cingulate cortex and medial prefrontal cortex.
Device: Accelerated deep iTBS
Sham TMS on anterior cingulate cortex and medial prefrontal cortex
Device: Accelerated Sham iTBS
Accelerated intermittant teta burst deep Transcranial Magnetic Stimulation on anterior cingulate cortex and medial prefrontal cortex 50 Hz
Sham accelerated intermittant teta burst Transcranial Magnetic Stimulation on anterior cingulate cortex and medial prefrontal cortex 50 Hz
Obsessive compulsive symptoms severity
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The minimum and maximum values are 0-40, and higher scores mean a worse outcome.
Time frame: pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)
Dimensional obsessive compulsive symptom severity
Dimensional Obsessive-Compulsive Scale (DOCS). The minimum and maximum values are 0-80, and higher scores mean a worse outcome.
Time frame: pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)
Severity of Depression
Hamilton Depression Rating Scale. The minimum and maximum values are 0-52, and higher scores mean a worse outcome
Time frame: pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)
Severity of anxiety
Hamilton Anxiety Rating Scale. The minimum and maximum values are 0-56, and higher scores mean a worse outcome.
Time frame: pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)
Plan to share: No
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Compulsive Personality Disorder→
Pamukkale University