Clinical and Electrophysiological Outcomes of tDCS in Patients With Treatment Resistant OCD
Obsessive-Compulsive Disorder
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring obsessive-compulsive disorder, treatment resistance, EEG, transcranial direct current stimulation
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.
Sites / Locations
- Tri-service general hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
The right cerebellum (anode) and the left OFC (cathode) tDCS
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
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.
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.
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.