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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05188833
Other study ID # EEG.DeepTMS.OCD
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 17, 2020
Est. completion date May 2022

Study information

Verified date October 2021
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date May 2022
Est. primary completion date October 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Beck Depression Scale It is the scale used for evaluated the level of depression. Higher score means worse result. 6 weeks after baseline
Secondary 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
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