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

NCT ID: NCT05595421

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-10
• Study Completion Date: 2023-05-31

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.

Detailed Description

Obsessive-compulsive disorder (OCD) typically starts between childhood and early adulthood and is characterized by the presence of obsessions and/or compulsions and a typically chronic clinical course. Around one-third of OCD patients fail to benefit significantly from first-line treatment, e.g., serotonin reuptake inhibitors (SRIs) or cognitive behavioral therapy (CBT). Combining, augmenting, and switching strategies as second-line treatments also fail to bring much benefit to these patients. When the first-line and second-line treatments fail, alternative treatments (e.g., non-invasive brain stimulation techniques) should be considered. A proposed pathophysiology of OCD is the dysfunction of cortico-striato-thalamo-cortical circuitry including the medial prefrontal cortex [i.e., supplementary motor area (SMA) and anterior cingulate cortex (ACC)], the dorso-lateral prefrontal cortex (DLPFC), the orbitofrontal cortex (OFC), and the basal ganglia. Among novel therapeutic options of non-invasive brain stimulation, transcranial direct current stimulation (tDCS) has shown positive results (e.g., cathodal tDCS over the pre-SMA, tDCS with the cathode over the left OFC and the anode over the right cerebellum, and tDCS with anode over Pre-SMA and cathode over right supra-orbital area) in treatment-resistant OCD. However, there is unclear evidence regarding the best tDCS montage for treatment-resistant OCD. This study investigates the effects of three different tDCS montages in reducing the symptoms of patients with treatment-resistant OCD. Eligible participants with treatment-resistant OCD will be allocated randomly into three groups of different tDCS montages [1. The right cerebellum (anode) and the left OFC (cathode) tDCS; 2. The bilateral pre-SMA (cathode) and right deltoid (reference) tDCS; 3. The left OFC (cathode 1), bilateral pre-SMA (cathode 2), and right deltoid (reference) tDCS]. 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. The primary outcome is the difference in the change of the score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) between three different montages of tDCS. Electrical activity of the brain as measured by EEG, autonomic function as measured by heart rate variability, and cognitive functioning as secondary outcomes will be measured before and after three different montages of tDCS.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

See detail in arm/group descriptions regarding the intervention.

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

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.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

See detail in arm/group descriptions regarding the intervention.

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

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.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

See detail in arm/group descriptions regarding the intervention.

Interventions

Transcranial direct current stimulation (tDCS)

See detail in arm/group descriptions regarding the intervention.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsin-An Chang, MD

Professor, Attending Psychiatrist, Department of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsin-An Chang, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Tri-service general hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

1-108-03-001

Identifier Type: -

Identifier Source: org_study_id