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

NCT05501132 | Completed Phase 1 DMC

• 1 other identifier: IR.ARUMS.REC.1399.102
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Symptom

Outcome Measures

Primary Outcomes (5)

• 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

• Response inhibition task 1

  Performance in the response inhibition tasks (Flanker test)

  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 2

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

  up to 1 month after the intervention

Secondary Outcomes (4)

• Beck Depression Questionnaire (BDI-II)

  up to 1 month after the intervention

• Quality of Life Questionnaire (WHOQUL)

  up to 1 month after the intervention

• electroencephalogram (EEG) oscillatory power

  up to 1 month after the intervention

• electroencephalogram (EEG) functional connectivity

  up to 1 month after the intervention

Study Arms (3)

tDCS group 1

EXPERIMENTAL

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

tDCS group 2

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

transcranial direct current stimulation DEVICE

Patients will receive 10 sessions of 20 minutes of either 1 mA, 2 mA or sham electrical stimulation on 5 consecutive days

Also known as: tDCS

Control group; tDCS group 1; tDCS group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ardabil University of Medical Sciences

Ardabil, Iran

Location

Related Publications (1)

• Alizadehgoradel J, Molaei B, Barzegar Jalali K, Pouresmali A, Sharifi K, Hallajian AH, Nejati V, Glinski B, Vicario CM, Nitsche MA, Salehinejad MA. Targeting the prefrontal-supplementary motor network in obsessive-compulsive disorder with intensified electrical stimulation in two dosages: a randomized, controlled trial. Transl Psychiatry. 2024 Feb 5;14(1):78. doi: 10.1038/s41398-024-02736-y.

  PMID: 38316750 RESULT

Related Links

• Published results

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 15, 2022
• Study Start: August 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: February 25, 2022
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)