NCT06177470

Brief Summary

H-coil high-frequency deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex (mPFC) and anterior cingulate cortex (ACC) has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder. At the same time, there are studies in the literature showing the effectiveness of intermittent theta burst stimulation application and the advantages of short treatment duration. However, there is no strong scientific evidence yet on the effectiveness and safety of iTBS (50 Hz) application with a double-cone coil in obsessive-compulsive disorder patients. The aim of this study is to evaluate the effectiveness of dTMS with ITBS protocol on the medial prefrontal cortex (mPFC) and anterior cingulate cortex (ACC) in OCD patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 11, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

December 18, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

December 11, 2023

Last Update Submit

December 11, 2023

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive compulsive disorderintermittant Teta Burst Transcranial Magnetic Stimulationaccelerated TMSTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

  • 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.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)

  • 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.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)

Secondary Outcomes (2)

  • Severity of Depression

    pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)

  • Severity of anxiety

    pretreatment (0.days) - as soon as the work is completed (10. days) - In the 2nd week after TMS application is completed (24. days)

Study Arms (2)

active accelerated deep TMS

ACTIVE COMPARATOR

Accelerated dTMS on anterior cingulate cortex and medial prefrontal cortex.

Device: Accelerated deep iTBS

sham TMS

SHAM COMPARATOR

Sham TMS on anterior cingulate cortex and medial prefrontal cortex

Device: Accelerated Sham iTBS

Interventions

Accelerated deep iTBSDEVICE

Accelerated intermittant teta burst deep Transcranial Magnetic Stimulation on anterior cingulate cortex and medial prefrontal cortex 50 Hz

active accelerated deep TMS
Accelerated Sham iTBSDEVICE

Sham accelerated intermittant teta burst Transcranial Magnetic Stimulation on anterior cingulate cortex and medial prefrontal cortex 50 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 the use of an SGI selective serotonin reuptake inhibitors at a sufficient dose and duration (at least 8 weeks) before the planned add-on treatment
  • No dose or active substance changes have been made in the treatment regimen for at least 8 weeks
  • Aged 18-65 years
  • Able to read and write
  • Not having a significant medical or neurological disease

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

Related Publications (5)

  • Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.

    PMID: 32252538BACKGROUND

  • Cole EJ, Phillips AL, Bentzley BS, Stimpson KH, Nejad R, Barmak F, Veerapal C, Khan N, Cherian K, Felber E, Brown R, Choi E, King S, Pankow H, Bishop JH, Azeez A, Coetzee J, Rapier R, Odenwald N, Carreon D, Hawkins J, Chang M, Keller J, Raj K, DeBattista C, Jo B, Espil FM, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022 Feb;179(2):132-141. doi: 10.1176/appi.ajp.2021.20101429. Epub 2021 Oct 29.

    PMID: 34711062BACKGROUND

  • Carmi L, Tendler A, Bystritsky A, Hollander E, Blumberger DM, Daskalakis J, Ward H, Lapidus K, Goodman W, Casuto L, Feifel D, Barnea-Ygael N, Roth Y, Zangen A, Zohar J. Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2019 Nov 1;176(11):931-938. doi: 10.1176/appi.ajp.2019.18101180. Epub 2019 May 21.

    PMID: 31109199BACKGROUND

  • Carmi L, Alyagon U, Barnea-Ygael N, Zohar J, Dar R, Zangen A. Clinical and electrophysiological outcomes of deep TMS over the medial prefrontal and anterior cingulate cortices in OCD patients. Brain Stimul. 2018 Jan-Feb;11(1):158-165. doi: 10.1016/j.brs.2017.09.004. Epub 2017 Sep 6.

    PMID: 28927961BACKGROUND

  • Akyol GK, Yucens B, Tumkaya S. Accelerated deep intermittent theta-burst stimulation for obsessive-compulsive disorder: A double-blind, randomized, controlled study. J Psychiatr Res. 2025 Sep;189:365-372. doi: 10.1016/j.jpsychires.2025.06.034. Epub 2025 Jun 24.

    PMID: 40578057DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Selim Tümkaya

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Selim Tümkaya

CONTACT

+902582964507selimtumkaya@gmail.com

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

December 11, 2023

First Posted

December 20, 2023

Study Start

December 18, 2023

Primary Completion

September 18, 2024

Study Completion

October 18, 2024

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)