Efficacy of Intensified Transcranial Direct Current Stimulation in Obsessive-compulsive Disorder

Obsessive-Compulsive Symptom Clinical Trial

Official title:

Efficacy of Transcranial Direct Current Stimulation (tDCS) in Symptoms, Quality of Life, Cognitive Deficits and Brain Physiology of Patients With Obsessive-compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05501132
• Other study ID #: IR.ARUMS.REC.1399.102
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2020
• Est. completion date: February 25, 2022

Study information

• Verified date: November 2023
• Source: The National Brain Mapping Laboratory (NBML)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 25, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Symptom

Intervention

Device:
• transcranial direct current stimulation
Patients will receive 10 sessions of 20 minutes of either 1 mA, 2 mA or sham electrical stimulation on 5 consecutive days

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ardabil University of Medical Sciences	Ardabil

Sponsors (3)

Lead Sponsor	Collaborator
The National Brain Mapping Laboratory (NBML)	Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive-Compulsive (Y-BOCS) rating scale	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.	up to 1 month after the intervention
Primary	Beck Anxiety Questionnaire (BAI)	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).	up to 1 month after the intervention
Primary	Response inhibition task 1	Performance in the response inhibition tasks (Flanker test)	up to 1 month after the intervention
Primary	Working memory task	Performance in the working memory task as an executive function task	up to 1 month after the intervention
Primary	Response inhibition task 2	Performance in the response inhibition tasks (Go/No-Go task)	up to 1 month after the intervention
Secondary	Beck Depression Questionnaire (BDI-II)	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.	up to 1 month after the intervention
Secondary	Quality of Life Questionnaire (WHOQUL)	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.	up to 1 month after the intervention
Secondary	electroencephalogram (EEG) oscillatory power	Change in the EEG power in alpha, delta, theta and beta bands	up to 1 month after the intervention
Secondary	electroencephalogram (EEG) functional connectivity	Change in the EEG functional connectivity	up to 1 month after the intervention