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

Primary Purpose

Obsessive-Compulsive Symptom

Status

Completed

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Symptom

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Ardabil University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

tDCS group 1

tDCS group 2

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

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).

Response inhibition task 1

Performance in the response inhibition tasks (Flanker test)

Working memory task

Performance in the working memory task as an executive function task

Response inhibition task 2

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

Secondary Outcome Measures

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.

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.

electroencephalogram (EEG) oscillatory power

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

electroencephalogram (EEG) functional connectivity

Change in the EEG functional connectivity

Full Information

NCT ID

NCT05501132

First Posted

August 12, 2022

Last Updated

July 15, 2023

Sponsor

The National Brain Mapping Laboratory (NBML)

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05501132

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

June 1, 2021 (Actual)

Study Completion Date

February 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The National Brain Mapping Laboratory (NBML)

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Symptom

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tDCS group 1

Arm Type

Experimental

Arm Description

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.

Arm Title

tDCS group 2

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

transcranial direct current stimulation

Other Intervention Name(s)

tDCS

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame