Clinical trial NCT05595421: Clinical and Electrophysiological Outcomes of tDCS in Patients With Treatment Resistant OCD
Official title: Clinical and Electrophysiological Outcomes of Transcranial Direct Current Stimulation in Patients With Treatment Resistant Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: obsessive-compulsive disorder
treatment resistance
EEG
transcranial direct current stimulation
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three arm/group parallel interventional study model.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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)
timeFrame: Six weeks
Secondary outcomes:
measure: 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)
timeFrame: Six weeks
measure: 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)
timeFrame: Six weeks
measure: 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)
timeFrame: Six weeks
measure: 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)
timeFrame: Six weeks
measure: 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)
timeFrame: Six weeks
measure: The changes over time in the results of Continuous Performance (CPT, version 2.0) (from baseline to the end of intervention)
timeFrame: Two weeks
measure: The changes over time in the results of Color Trails Test (CTT) (from baseline to the end of intervention)
timeFrame: Two weeks
measure: The changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the end of intervention)
timeFrame: Two weeks
measure: The changes over time in the results of Tower of London test (from baseline to the end of intervention)
timeFrame: Two weeks
measure: The change over time in the score of the Digit Symbol Substitution Test (DSST) (from baseline to the end of intervention)
timeFrame: Two weeks
measure: The changes over time in indices of heart rate variability (HRV) (from baseline to the end of intervention)
timeFrame: Two weeks
measure: The changes over time in EEG absolute power and coherence (from baseline to the end of intervention)
timeFrame: Two weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-service general hospital
Study officials:
affiliation: Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwa
name: Hsin-An Chang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: