Efficacy of Intensified Transcranial Direct Current Stimulation in Obsessive-compulsive Disorder
- Conditions
- Obsessive-Compulsive Symptom
- Interventions
- Device: transcranial direct current stimulation
- Registration Number
- NCT05501132
- Lead Sponsor
- The National Brain Mapping Laboratory (NBML)
- Brief Summary
This is a randomized, double-blind, parallel-group, sham-controlled trial that aims to investigate the effectiveness of transcranial direct current stimulation (TDCS) on improving symptoms, quality of life, depression, and cognitive functions in 39 patients with obsessive-compulsive disorder (OCD) that are randomized in 3 experimental groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Diagnosis of Obsessive-compulsive Disorder by a psychiatrist and DSM-5-based behavioral checklist
- being 18-50 years old
- providing written informed consent
- If female, negative urine pregnancy test
- stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment and during the experiment
- smoker
- pregnancy
- alcohol or substance dependence
- history of seizure
- history of neurological disorder
- history of head injury
- presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tDCS group 1 transcranial direct current stimulation In the first experimental group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of 1 mA electrical stimulation on 5 consecutive days with two sessions per day. tDCS group 2 transcranial direct current stimulation In the second experimental group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of 2 mA electrical stimulation on 5 consecutive days with two sessions per day. Control group transcranial direct current stimulation In the placebo group, the TDCS intervention protocol consists of 10 sessions of 20 minutes of sham electrical stimulation on 5 consecutive days with two sessions per day.
- Primary Outcome Measures
Name Time Method Beck Anxiety Questionnaire (BAI) up to 1 month after the intervention Score in the Beck Anxiety Questionnaire (BAI). The BAI scores are classified as minimal anxiety (0 to 7), mild anxiety (8 to 15), moderate anxiety (16 to 25), and severe anxiety (30 to 63).
Yale-Brown Obsessive-Compulsive (Y-BOCS) rating scale up to 1 month after the intervention Score in the Yale-Brown Obsessive-Compulsive (Y-BOCS). Total scores on the measure range from 0 to 40, with a score of 0-7 indicating subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms.
Response inhibition task 1 up to 1 month after the intervention Performance in the response inhibition tasks (Flanker test)
Working memory task up to 1 month after the intervention Performance in the working memory task as an executive function task
Response inhibition task 2 up to 1 month after the intervention Performance in the response inhibition tasks (Go/No-Go task)
- Secondary Outcome Measures
Name Time Method Beck Depression Questionnaire (BDI-II) up to 1 month after the intervention Score in the Beck Depression Questionnaire (BDI-II). The BDI-II scores are classified as below:
Score of 1-10: These ups and downs are considered normal. Score of 11-16: Mild mood disturbance. Score of 17-20: Borderline clinical depression. Score of 21-30: Moderate depression. Score of 31-40: Severe depression. Score of 40+ Extreme depression.electroencephalogram (EEG) oscillatory power up to 1 month after the intervention Change in the EEG power in alpha, delta, theta and beta bands
electroencephalogram (EEG) functional connectivity up to 1 month after the intervention Change in the EEG functional connectivity
Quality of Life Questionnaire (WHOQUL) up to 1 month after the intervention Score in the Quality of Life Questionnaire. It has 26 items and each item is rated on a 5-point scale with a higher score indicative of higher quality of life.
Trial Locations
- Locations (1)
Ardabil University of Medical Sciences
🇮🇷Ardabīl, Iran, Islamic Republic of