dTMS in Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Effectiveness of Deep Transcranial Magnetic Stimulation to Medial Prefrontal Cortex and Anterior Cingulate Cortex in Obsessive-Compulsive Disorder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06077370
• Other study ID #: 2021TIPF029
• Status: Completed
• Phase: N/A
• Start date: November 27, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: October 2023
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 25, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of obsessive-compulsive disorder

• 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

• Aged 18-65 years

• Able to read and write

Exclusion Criteria:

• Not providing consent to participate in the study

• 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.)

• Diagnosis of an important medical or neurological disease (e.g., epilepsy);

• Mental retardation

• Illiteracy

• Having received electroconvulsive therapy (ECT) or TMS within the last six months;

• Having any prosthesis, such as an implant and pacemaker.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• deep TMS
Deep Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.
• Sham TMS
Sham Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Secondary	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)
Secondary	Severity of anxiety	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)