dTMS in Obsessive Compulsive Disorder
Study Details
Study Description
Brief Summary
High-frequency deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC) with an H-coil has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder (OCD). However, there is not yet strong scientific evidence concerning the efficacy and safety of performing a similar procedure with a double-cone coil or in an accelerated manner. The aim of this study was evaluating the efficacy of dTMS over the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC) in an accelerated manner with double-cone coil.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The current study aimed to investigate the efficacy and safety of multiple deep stimulations per day with a double-cone coil to the mPFC and ACC in treatment-resistant patients with OCD. This study evaluated (I) the effectiveness of high-frequency stimulation of the mPFC and ACC with a double cone coil, and (II) the effectiveness of the application of this protocol in three weeks, not six weeks as approved by the FDA. The participants were randomized into two parallel groups in a double-blind manner. High frequency (20 Hz) dTMS was applied to the mPFC and ACC in one group and sham dTMS to the same regions in the other group, twice a day, for a total of 30 sessions. This application was for three weeks in total, excluding weekends.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: dTMS group dTMS on anterior cingulate cortex and medial prefrontal cortex. |
Device: deep TMS
Deep Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.
|
| Sham Comparator: sham TMS Sham TMS on anterior cingulate cortex and medial prefrontal cortex. |
Device: Sham TMS
Sham Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.
|
Outcome Measures
Primary Outcome Measures
- Obsessive compulsive symptoms severity [pretreatment(0.weeks)-as soon as the work is completed (3 weeks)]
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The minimum and maximum values are 0-40, and higher scores mean a worse outcome.
- Dimensional obsessive compulsive symptom severity [pretreatment(0.weeks)-as soon as the work is completed (3 weeks)]
Dimensional Obsessive-Compulsive Scale (DOCS). The minimum and maximum values are 0-80, and higher scores mean a worse outcome.
- Severity of side effects [pretreatment(0.weeks)-as soon as the work is completed (3 weeks)]
Clinical Global Impression - The efficacy index. The minimum and maximum values are 1-4, and higher scores mean a worse outcome.
Secondary Outcome Measures
- Severity of Depression [pretreatment(0.weeks)-as soon as the work is completed (3 weeks)]
Hamilton Depression Rating Scale. The minimum and maximum values are 0-52, and higher scores mean a worse outcome.
- Severity of anxiety [pretreatment(0.weeks)-as soon as the work is completed (3 weeks)]
Hamilton Anxiety Rating Scale. The minimum and maximum values are 0-56, and higher scores mean a worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of obsessive-compulsive disorder
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Not having an adequate response to treatment despite using at least two selective serotonin reuptake inhibitors at a sufficient dose and duration for 12 weeks before the planned add-on treatment
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Aged 18-65 years
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Able to read and write
Exclusion Criteria:
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Not providing consent to participate in the study
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Diagnosis of a psychiatric disorder, such as psychotic disorder, bipolar disorder, major depressive disorder [Hamilton Depression Rating Scale (HDRS) score above 17], mental retardation, alcohol-substance use disorder, and organic mental disorder (dementia, delirium, and head trauma, etc.)
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Diagnosis of an important medical or neurological disease (e.g., epilepsy);
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Mental retardation
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Illiteracy
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Having received electroconvulsive therapy (ECT) or TMS within the last six months;
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Having any prosthesis, such as an implant and pacemaker.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pamukkale University | Denizli | Turkey | 20160 |
Sponsors and Collaborators
- Pamukkale University
Investigators
- Study Director: Selim Tümkaya, MD, Pamukkale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021TIPF029