Back to resultsdTMS in Obsessive Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
deep TMS
Sham TMS
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring obsessive compulsive disorder, Transcranial Magnetic Stimulation
Eligibility Criteria
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.
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
dTMS group
sham TMS
Arm Description
dTMS on anterior cingulate cortex and medial prefrontal cortex.
Sham TMS on anterior cingulate cortex and medial prefrontal cortex.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Severity of Depression
Hamilton Depression Rating Scale. The minimum and maximum values are 0-52, and higher scores mean a worse outcome.
Severity of anxiety
Hamilton Anxiety Rating Scale. The minimum and maximum values are 0-56, and higher scores mean a worse outcome.
Full Information
NCT ID
NCT06077370
First Posted
September 27, 2023
Last Updated
October 8, 2023
Sponsor
Pamukkale University
1. Study Identification
Unique Protocol Identification Number
NCT06077370
Brief Title
dTMS in Obsessive Compulsive Disorder
Official Title
Effectiveness of Deep Transcranial Magnetic Stimulation to Medial Prefrontal Cortex and Anterior Cingulate Cortex in Obsessive-Compulsive Disorder Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 27, 2022 (Actual)
Primary Completion Date
February 24, 2023 (Actual)
Study Completion Date
May 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
obsessive compulsive disorder, Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dTMS group
Arm Type
Active Comparator
Arm Description
dTMS on anterior cingulate cortex and medial prefrontal cortex.
Arm Title
sham TMS
Arm Type
Sham Comparator
Arm Description
Sham TMS on anterior cingulate cortex and medial prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
deep TMS
Intervention Description
Deep Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.
Intervention Type
Device
Intervention Name(s)
Sham TMS
Intervention Description
Sham Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.
Primary Outcome Measure Information:
Title
Obsessive compulsive symptoms severity
Description
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The minimum and maximum values are 0-40, and higher scores mean a worse outcome.
Time Frame
pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Title
Dimensional obsessive compulsive symptom severity
Description
Dimensional Obsessive-Compulsive Scale (DOCS). The minimum and maximum values are 0-80, and higher scores mean a worse outcome.
Time Frame
pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Title
Severity of side effects
Description
Clinical Global Impression - The efficacy index. The minimum and maximum values are 1-4, and higher scores mean a worse outcome.
Time Frame
pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Secondary Outcome Measure Information:
Title
Severity of Depression
Description
Hamilton Depression Rating Scale. The minimum and maximum values are 0-52, and higher scores mean a worse outcome.
Time Frame
pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
Title
Severity of anxiety
Description
Hamilton Anxiety Rating Scale. The minimum and maximum values are 0-56, and higher scores mean a worse outcome.
Time Frame
pretreatment(0.weeks)-as soon as the work is completed (3 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selim Tümkaya, MD
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20160
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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dTMS in Obsessive Compulsive Disorder
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