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EEG Results of Deep TMS in Patients With OCD

Primary Purpose

Obsessive-Compulsive Disorder, EEG With Periodic Abnormalities

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Deep Transcranial Magnetic Stimulation
Paroxetine
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive compulsive disorder, Deep Transcranial Magnetic Stimulation, Mood, Quality of Life, EEG

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being diagnosed with Obsessive Compulsive Disorder within the framework of DSM-5 criteria

Exclusion Criteria:

  • Not volunteering to comply with the research program
  • Presence of a metal piece on the head
  • Having a pacemaker inserted
  • Having had a previous epileptic seizure

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Deep Transcranial Magnetic Stimulation

Deep Transcranial Magnetic Stimulation and Paroxetine

Paroxetine

Arm Description

The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string.

The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string. In addtion to DTMMS, paroxetine will applied.

Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression in OCD.

Outcomes

Primary Outcome Measures

Electroencephalography
It is an electrophysiological neuroimaging method frequently used in neuroscience and clinic, in which the activity between neural circuits can be measured and observed non-invasively in the form of electrical waves.

Secondary Outcome Measures

Beck Depression Scale
It is the scale used for evaluated the level of depression. Higher score means worse result.
World Health Organization Quality of Life Scale Short Form
It is the scale used for evaluated the level of quality of life. It contains a total of 26 questions. Higher score means better result.

Full Information

First Posted
December 26, 2021
Last Updated
December 26, 2021
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05188833
Brief Title
EEG Results of Deep TMS in Patients With OCD
Official Title
Electrophysiological Results of the Efficacy of Deep Transcranial Magnetic Stimulation on Mood State and Quality of Life in Obsessive Compulsive Disorder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 17, 2020 (Actual)
Primary Completion Date
October 20, 2021 (Actual)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obsessive Compulsive Disorder (OCD) is a psychiatric disorder in which involuntary thoughts and irresistible behaviors are seen and its prevalence affects 2%-3% of the general population. Deep TMS is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, and in addition to drug treatment and psychotherapy approaches, magnetic stimulation of localized brain regions and disease symptoms are addressed. The presence of the medial prefrontal cortex and anterior cingulate cortex in the dysfunction on the specified cycle seen in OCD patients indicates that the stimulation of these regions is necessary for a meaningful result in the treatment of deep TMS; studies show that the effect of the deep TMS method emerges as a result of the stimulation of these regions. 30 patients with OCD will included into the study and dividen into 3 groups (DTMS (n=10), DTMS + Paroxetine (n=10), Control(n=10)). Patients will evaluated in terms of depression, quality of life, and EEG before and after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder, EEG With Periodic Abnormalities
Keywords
Obsessive compulsive disorder, Deep Transcranial Magnetic Stimulation, Mood, Quality of Life, EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string.
Arm Title
Deep Transcranial Magnetic Stimulation and Paroxetine
Arm Type
Experimental
Arm Description
The treatment will be carried out for 6 weeks, 5 days a week, in total 30 sessions; 20 hz using Brainsway H-7 helmet. It will be applied to the mPFC and ACC simultaneously with a total of 2000 beats at a frequency of 50 beats in each string. In addtion to DTMMS, paroxetine will applied.
Arm Title
Paroxetine
Arm Type
Active Comparator
Arm Description
Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression in OCD.
Intervention Type
Device
Intervention Name(s)
Deep Transcranial Magnetic Stimulation
Intervention Description
Deep TMS, unlike traditional TMS, is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, in addition to drug treatment and psychotherapy approaches, in addition to localized brain regions magnetic stimulation is a treatment method where disease symptoms are addressed.
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Description
Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression.
Primary Outcome Measure Information:
Title
Electroencephalography
Description
It is an electrophysiological neuroimaging method frequently used in neuroscience and clinic, in which the activity between neural circuits can be measured and observed non-invasively in the form of electrical waves.
Time Frame
6 weeks after baseline
Secondary Outcome Measure Information:
Title
Beck Depression Scale
Description
It is the scale used for evaluated the level of depression. Higher score means worse result.
Time Frame
6 weeks after baseline
Title
World Health Organization Quality of Life Scale Short Form
Description
It is the scale used for evaluated the level of quality of life. It contains a total of 26 questions. Higher score means better result.
Time Frame
6 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being diagnosed with Obsessive Compulsive Disorder within the framework of DSM-5 criteria Exclusion Criteria: Not volunteering to comply with the research program Presence of a metal piece on the head Having a pacemaker inserted Having had a previous epileptic seizure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miray BUDAK, PhD
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34815
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

EEG Results of Deep TMS in Patients With OCD

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