NCT06077370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 27, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 27, 2023

Last Update Submit

October 8, 2023

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive compulsive disorderTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Severity of Depression

    pretreatment(0.weeks)-as soon as the work is completed (3 weeks)

  • Severity of anxiety

    pretreatment(0.weeks)-as soon as the work is completed (3 weeks)

Study Arms (2)

dTMS group

ACTIVE COMPARATOR

dTMS on anterior cingulate cortex and medial prefrontal cortex.

Device: deep TMS

sham TMS

SHAM COMPARATOR

Sham TMS on anterior cingulate cortex and medial prefrontal cortex.

Device: Sham TMS

Interventions

deep TMSDEVICE

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

dTMS group
Sham TMSDEVICE

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

sham TMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Selim Tümkaya, MD

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 27, 2023

First Posted

October 11, 2023

Study Start

November 27, 2022

Primary Completion

February 24, 2023

Study Completion

May 25, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)