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

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Symptom
• Intervention / Treatment: Device: transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Ardabīl, Iran, Islamic Republic of
    • Ardabil University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

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
Experimental: tDCS group 1; 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.	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; Other Names: tDCS
Experimental: tDCS group 2; 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.	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; Other Names: tDCS
Placebo Comparator: Control group; 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.	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; Other Names: tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Working memory task	Performance in the working memory task as an executive function task	up to 1 month after the intervention
Response inhibition task 1	Performance in the response inhibition tasks (Flanker test)	up to 1 month after the intervention
Response inhibition task 2	Performance in the response inhibition tasks (Go/No-Go task)	up to 1 month after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
electroencephalogram (EEG) oscillatory power	Change in the EEG power in alpha, delta, theta and beta bands	up to 1 month after the intervention
electroencephalogram (EEG) functional connectivity	Change in the EEG functional connectivity	up to 1 month after the intervention

Collaborators and Investigators

• Sponsor: The National Brain Mapping Laboratory (NBML)
• Collaborators: Ardabil University of Medical Sciences; Leibniz Research Centre for Working Environment and Human Factors

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): February 25, 2022

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: IR.ARUMS.REC.1399.102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No