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

The National Brain Mapping Laboratory (NBML)

Status and phase: Completed; Phase 1

Conditions: Obsessive-Compulsive Symptom

Treatments: Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05501132

IR.ARUMS.REC.1399.102

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups, including a placebo group

tDCS group 1

Experimental group

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.

Treatment:

Device: transcranial direct current stimulation

tDCS group 2

Experimental group

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.

Treatment:

Device: transcranial direct current stimulation

Control group

Placebo Comparator group

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.

Treatment:

Device: transcranial direct current stimulation