Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dTMS group | Active Comparator | dTMS on anterior cingulate cortex and medial prefrontal cortex. |
|
| sham TMS | Sham Comparator | Sham TMS on anterior cingulate cortex and medial prefrontal cortex. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep TMS | Device | Deep Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pretreatment(0.weeks)-as soon as the work is completed (3 weeks) |
| 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. | pretreatment(0.weeks)-as soon as the work is completed (3 weeks) |
| Severity of side effects | Clinical Global Impression - The efficacy index. The minimum and maximum values are 1-4, and higher scores mean a worse outcome. | pretreatment(0.weeks)-as soon as the work is completed (3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Depression | Hamilton Depression Rating Scale. The minimum and maximum values are 0-52, and higher scores mean a worse outcome. | pretreatment(0.weeks)-as soon as the work is completed (3 weeks) |
| Severity of anxiety |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Selim Tümkaya, MD | Pamukkale University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamukkale University | Denizli | 20160 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham TMS | Device | Sham Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz. |
|
Hamilton Anxiety Rating Scale. The minimum and maximum values are 0-56, and higher scores mean a worse outcome.
| pretreatment(0.weeks)-as soon as the work is completed (3 weeks) |