EEG Results of Deep TMS in Patients With OCD

NCT05188833 | Unknown

• 1 other identifier: EEG.DeepTMS.OCD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder; EEG With Periodic Abnormalities

Keywords

Obsessive compulsive disorder; Deep Transcranial Magnetic Stimulation; Mood; Quality of Life; EEG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Beck Depression Scale

  6 weeks after baseline

• World Health Organization Quality of Life Scale Short Form

  6 weeks after baseline

Study Arms (3)

Deep Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

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 Transcranial Magnetic Stimulation and Paroxetine

EXPERIMENTAL

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; Drug: Paroxetine

Paroxetine

ACTIVE COMPARATOR

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

Interventions

Deep Transcranial Magnetic Stimulation DEVICE

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.

Deep Transcranial Magnetic Stimulation; Deep Transcranial Magnetic Stimulation and Paroxetine

Paroxetine DRUG

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

Deep Transcranial Magnetic Stimulation and Paroxetine; Paroxetine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Miray BUDAK, PhD

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 12, 2022
• Study Start: May 17, 2020
• Primary Completion: October 20, 2021
• Study Completion: May 1, 2022
• Last Updated: January 12, 2022

Record last verified: 2021-10

Locations

TU (1)