dTMS in Obsessive Compulsive Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: deep TMS; Device: Sham TMS

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20160
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Study Director: Selim Tümkaya, MD, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2022
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; obsessive compulsive disorder
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2021TIPF029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No