EEG Results of Deep TMS in Patients With OCD

Electrophysiological Results of the Efficacy of Deep Transcranial Magnetic Stimulation on Mood State and Quality of Life in Obsessive Compulsive Disorder Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obsessive-Compulsive Disorder; EEG With Periodic Abnormalities
• Intervention / Treatment: Device: Deep Transcranial Magnetic Stimulation; Drug: Paroxetine

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beykoz
    • Istanbul, Beykoz, Turkey, 34815
      • Istanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Deep Transcranial Magnetic Stimulation; 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.	Device: Deep Transcranial Magnetic Stimulation; 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.
Experimental: Deep Transcranial Magnetic Stimulation and Paroxetine; 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.	Device: Deep Transcranial Magnetic Stimulation; 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.; Drug: Paroxetine; Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression.
Active Comparator: Paroxetine; Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression in OCD.	Drug: Paroxetine; Paroxetine is a type of antidepressant known as an SSRI (selective serotonin reuptake inhibitor). It's often used to treat depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Scale	It is the scale used for evaluated the level of depression. Higher score means worse result.	6 weeks after baseline
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.	6 weeks after baseline

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2020
• Primary Completion (Actual): October 20, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: December 26, 2021
• First Submitted That Met QC Criteria: December 26, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; EEG; Mood; Obsessive compulsive disorder; Deep Transcranial Magnetic Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: EEG.DeepTMS.OCD

Drug and device information, study documents

• 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