Clinical and Electrophysiological Outcomes of tDCS in Patients With Treatment Resistant OCD

NCT05595421 | Completed

• 1 other identifier: 1-108-03-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to analyze the effectiveness of three different montages of transcranial direct current stimulation (tDCS) in treating treatment-resistant OCD.

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorder; treatment resistance; EEG; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• The change over time in the score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)

  The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted.

  Six weeks

Secondary Outcomes (12)

• The change over time in the score of self-reporting OCD Visual Analog Scale (OCD-VAS) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)

  Six weeks

• The change over time in the score of the Clinical Global Impression improvement (CGI-I) subscales of the CGI-S (severity scale) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)

  Six weeks

• The change over time in the score of Hamilton Depression Rating Scale (HAM-D) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)

  Six weeks

• The change over time in the score of Hamilton Anxiety Rating Scale (HAM-A) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)

  Six weeks

• The change over time in the score of the Taiwanese version of World Health Organization Quality of Life-BREF (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)

  Six weeks

Study Arms (3)

The right cerebellum (anode) and the left OFC (cathode) tDCS

EXPERIMENTAL

Stimulation sessions will be carried out using a neuroConn DC stimulator (Ilmeneau, GmbH) with two rubber electrodes placed inside two 5 × 7 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl). Electrodes will be placed on the basis of the international 10-20 electrodes placement system. The cathode will be placed over the left OFC on the FP1 point according to the EEG international reference. The anode will be placed over the right cerebellum 3 cm below the inion and 1 cm right from the midline. Patients will receive twice-daily sessions separated by at least 1 h for 10 consecutive weekdays. One session of tDCS consists in delivering a direct current of 2 mA during 20 min.

Device: Transcranial direct current stimulation (tDCS)

The bilateral pre-SMA (cathode) and right deltoid (reference) tDCS

EXPERIMENTAL

Stimulation sessions will be carried out using a neuroConn DC stimulator (Ilmeneau, GmbH). The stimulator is connected to two rubber electrodes which are placed inside two sponge electrodes soaked in a saline solution (0.9% NaCl), respectively. The active electrode (cathode) is 5×5 cm and placed on the sagittal midline at 15% of the distance between inion and nasion anterior to Cz (vertex), using the International 10-20 EEG System, to target the bilateral presupplementary motor area (pre-SMA). The reference electrode is 5×7 cm and placed on the lateral surface of the patient's right deltoid. Patients will receive twice-daily sessions separated by at least 1 h for 10 consecutive weekdays. One session of tDCS consists in delivering a direct current of 2 mA during 20 min.

Device: Transcranial direct current stimulation (tDCS)

The left OFC (cathode 1), bilateral pre-SMA (cathode 2), and right deltoid (reference) tDCS

EXPERIMENTAL

Stimulation sessions are carried out using a neuroConn DC stimulator (Ilmeneau, GmbH). The stimulator is connected to a 2 × 1 wire adaptor (Equalizer Box, NeuroConn) that links three rubber electrodes placed inside sponge electrodes soaked in a saline solution (0.9% NaCl) will be applied. One active electrode (the 1st cathode) is 5×5 cm and placed on the sagittal midline at 15% of the distance between inion and nasion anterior to Cz (vertex), using the International 10-20 EEG System, to target the bilateral presupplementary motor area (pre-SMA). The other active electrode (the 2nd cathode) is 5×7 cm and placed over the left OFC on the FP1 point according to the EEG international system. The reference electrode is 5×7 cm and placed on the lateral surface of the patient's right deltoid. Patients will receive twice-daily sessions separated by at least 1 h for 10 consecutive weekdays. One session of tDCS consists in delivering a direct current of 2 mA during 20 min.

Device: Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

See detail in arm/group descriptions regarding the intervention.

The bilateral pre-SMA (cathode) and right deltoid (reference) tDCS; The left OFC (cathode 1), bilateral pre-SMA (cathode 2), and right deltoid (reference) tDCS; The right cerebellum (anode) and the left OFC (cathode) tDCS

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants aged 20-65 with the primary clinical diagnosis of DSM-5-defined obsessive-compulsive disorder.
• Being treatment-resistant, as revealed by a Yale-Brown Obsessive and Compulsive Scale score (Y-BOCS) \>16 despite at least two selective serotonin reuptake inhibitor (SSRI) trials of adequate dose and duration (or refusal to take medication for personal choice) and having been offered prior cognitive behavior therapy (CBT) by a trained practitioner.
• The dosages of undergoing psychopharmacological medications having remained unchanged for 1 month before the beginning of the trial and remaining unchanged throughout the entire duration of the study.
• Agreement to participate in the study and provide the written informed consent.

You may not qualify if:

• Having contraindications for transcranial electrical stimulation or transcranial magnetic stimulation, e.g., pacemakers, metallic or magnetic pieces in the head/brain, ear implants and other implantable brain medical devices.
• Pregnancy or breastfeeding at enrollment.
• Having active substance use disorder (in exception to caffeine and/or tobacco).
• Having a history of seizures.
• Having a history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases.
• Skin lesions on scalp at the area of electrode application.
• Having unstable medical conditions at enrollment.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hsin-An Chang, M.D.

  Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study outcomes are measured by clinical raters blinded to the arms and interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Attending Psychiatrist, Department of Psychiatry

Model Details: A three arm/group parallel interventional study model.

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 27, 2022
• Study Start: July 10, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)