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Completed

NCT Number: NCT06077370

dTMS in Obsessive Compulsive Disorder

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

deep TMS

Device

Deep Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.

Sham TMS

Device

Sham Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.

Primary outcomes

  1. Obsessive compulsive symptoms severity

    Time frame: 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.

  2. Dimensional obsessive compulsive symptom severity

    Time frame: 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.

  3. Severity of side effects

    Time frame: 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 outcomes

  1. Severity of Depression

    Time frame: 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.

  2. Severity of anxiety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2023
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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