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Efficacy of Transcranial Direct Current Stimulation in Obsessive-compulsive Disorder

Sponsor
The National Brain Mapping Laboratory (NBML) (Other)
Overall Status
Completed
CT.gov ID
NCT05501132
Collaborator
Ardabil University of Medical Sciences (Other), Leibniz Research Centre for Working Environment and Human Factors (Other)
37
Enrollment
1
Location
3
Arms
18.8
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: transcranial direct current stimulation
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Feb 25, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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).

    3. Response inhibition task [up to 1 month after the intervention]

      Performance in the response inhibition task (Go/No-Go)

    4. Working memory task [up to 1 month after the intervention]

      Performance in the working memory task as an executive function task

    Secondary Outcome Measures

    1. 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.

    2. 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.

    3. electroencephalogram (EEG) power spectrum [up to 1 month after the intervention]

      Change in the EEG power spectrum

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of autism spectrum disorder by a psychiatrist and DSM-5 based behavioral checklist

    • being 18-50 years old

    • providing written informed consent signed by parents

    • 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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ardabil University of Medical Sciences Ardabīl Iran, Islamic Republic of

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohammad Ali Salehinejad, Principal Investigator, The National Brain Mapping Laboratory (NBML)
    ClinicalTrials.gov Identifier:
    NCT05501132
    Other Study ID Numbers:
    • IR.ARUMS.REC.1399.102
    First Posted:
    Aug 15, 2022
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Compulsive Personality Disorder
    Obsessive-Compulsive Disorder

    Study Results

    No Results Posted as of Aug 17, 2022