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NCT Number: NCT05501132

Efficacy of Intensified Transcranial Direct Current Stimulation in 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.

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Key information

Conditions

Obsessive-Compulsive Symptom

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ardabil University of Medical Sciences

Ardabil, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: tDCS

Primary outcomes

  1. Yale-Brown Obsessive-Compulsive (Y-BOCS) rating scale

    Time frame: 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)

    Time frame: 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 1

    Time frame: up to 1 month after the intervention

    Performance in the response inhibition tasks (Flanker test)

  4. Working memory task

    Time frame: up to 1 month after the intervention

    Performance in the working memory task as an executive function task

  5. Response inhibition task 2

    Time frame: up to 1 month after the intervention

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

Secondary outcomes

  1. Beck Depression Questionnaire (BDI-II)

    Time frame: 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)

    Time frame: 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) oscillatory power

    Time frame: up to 1 month after the intervention

    Change in the EEG power in alpha, delta, theta and beta bands

  4. electroencephalogram (EEG) functional connectivity

    Time frame: up to 1 month after the intervention

    Change in the EEG functional connectivity

Sponsors and collaborators

Lead sponsor

The National Brain Mapping Laboratory (NBML)

Other

Collaborators

  • Ardabil University of Medical Sciences
  • Leibniz Research Centre for Working Environment and Human Factors

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 15, 2022
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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