Neuromodulation for Obsessive-Compulsive Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Boston University Charles River Campus
Disqualifiers: Bipolar, Psychotic disorders, Tourette, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?Although multiple treatments for OCD exist, slow symptom decrease, high remission, and significant side effects for some OCD patients limit their efficacy. More research into the precise neural mechanisms and linked cognitive functions in OCD is also necessary. To address both concerns, this study by Dr. Reinhart and his team will test a new, non-invasive, and well-tolerated neuromodulation method for reducing OCD symptoms, based on reward-related rhythms of the orbitofrontal cortex (OFC; a brain region responsible for reward, decision making and other crucial functions that is affected by OCD). This proposal is based on highly encouraging preliminary data in both subsyndromal and treatment-resistant populations that shows rapid reductions in OCD behaviors that last at least 1-3 months. Using high-definition transcranial alternating current stimulation (HD-tACS) guided by EEG brain wave recordings, the study will test whether repetitive modulation of relevant rhythm activity in the OFC can lead to rapid (within five days) and sustainable (up to three months) OCD symptom reduction. This research aims to increase knowledge of OCD and development of effective treatment with minimal side effects.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that there have been no changes to your OCD medication or therapy in the last 3 months. This suggests you should continue your current treatment without changes.
What data supports the effectiveness of the treatment High Definition Transcranial Alternating Current Stimulation (HD-tACS) for Obsessive-Compulsive Disorder?
Research on a similar treatment, transcranial direct current stimulation (tDCS), shows it can reduce symptoms in patients with treatment-resistant OCD. For example, one study found a 26% reduction in symptoms after using tDCS, suggesting that non-invasive brain stimulation techniques like HD-tACS might also be effective.
12345Is transcranial alternating current stimulation (tACS) safe for humans?
Research indicates that transcranial alternating current stimulation (tACS) is generally safe and well-tolerated in humans, with no severe adverse events reported in studies, including those involving people with major depressive disorder. Mild side effects like tinnitus (ringing in the ears) have been noted, but these are not serious.
678910How is HD-tACS different from other treatments for OCD?
HD-tACS is a unique treatment for OCD because it uses alternating electrical currents to modulate brain activity non-invasively, targeting specific brain areas involved in OCD, unlike traditional medications or therapies that may not directly target these brain circuits.
411121314Eligibility Criteria
This trial is for adults with OCD who score at least 16 on the YBOCS, can consent to participate, and follow study rules. It's not for those with severe depression, pregnancy, metal head implants, electronic devices in body, vision issues despite correction, claustrophobia or neurological disorders like epilepsy.Inclusion Criteria
I have been diagnosed with OCD.
Score of 16 or greater on the YBOCS
I am 18 years old or older.
+1 more
Exclusion Criteria
I have severe depression.
Suicidal risk as determined by moderate or greater score on the Columbia Suicide Severity Rating Scale (C-SSRS)
Organic brain syndrome, mental retardation, or other potentially interfering cognitive dysfunction
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive high-definition transcranial alternating current stimulation (HD-tACS) guided by EEG brain wave recordings to modulate orbitofrontal cortex activity
5 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
3 months
Participant Groups
The study tests a new non-invasive neuromodulation technique using HD-tACS guided by EEG to reduce OCD symptoms quickly (within five days) and sustainably (up to three months). The focus is on modulating brain rhythms in the OFC that are linked with reward and decision-making.
2Treatment groups
Active Control
Placebo Group
Group I: Active HD-tACSActive Control1 Intervention
HD-tACS of OFC
Group II: Sham HD-tACSPlacebo Group1 Intervention
HD-tACS of OFC
High Definition Transcranial Alternating Current Stimulation is already approved in United States for the following indications:
🇺🇸 Approved in United States as HD-tACS for:
- Obsessive-compulsive disorder (OCD) - Research and experimental use
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston University Center for Anxiety and Related Disorders (BU-CARD)Boston, MA
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Who Is Running the Clinical Trial?
Boston University Charles River CampusLead Sponsor
References
Treating refractory obsessive-compulsive disorder with transcranial direct current stimulation: An open label study. [2021]Obsessive-compulsive disorder (OCD) is a complex disorder with 40%-60% of patients' refractory to treatment. Transcranial direct current stimulation (tDCS) has been shown to induce potent and long-lasting effects on cortical excitability. The aim of the present clinical trial was to evaluate the therapeutic efficacy and tolerability of cathodal tDCS over the supplementary motor area (SMA) in treatment-resistant OCD patients.
Transcranial direct current stimulation for treatment-resistant obsessive-compulsive disorder-A large case series. [2021]The present study is a large case series evaluating the benefits of transcranial direct current stimulation (tDCS) in treatment-resistant obsessive compulsive disorder (OCD).
Transcranial direct current stimulation in patients with obsessive compulsive disorder: A randomized controlled trial. [2020]Obsessive-compulsive disorder (OCD) is a severe mental disorder with poor response to the available treatments. Neuroimaging studies have identified dysfunctions within the orbito-fronto-striato-pallido-thalamic network in patients with OCD. Here, we assessed the efficacy and safety of transcranial direct current stimulation (tDCS) applied with the cathode over the orbitofrontal cortex (OFC) and the anode over the right cerebellum to decrease OCD symptoms in patients with treatment-resistant OCD.
Efficacy of Cathodal Transcranial Direct Current Stimulation Over the Left Orbitofrontal Cortex in a Patient With Treatment-Resistant Obsessive-Compulsive Disorder. [2022]Obsessive-compulsive disorder (OCD) is a disabling and frequent neuropsychiatric disorder. Forty percent to 60% of patients with OCD fail to respond to available treatments. Neuroimaging studies have highlighted an association between the severity of obsessive and compulsive symptoms and an increased activity of the left orbitofrontal cortex (OFC) in patients with OCD. Transcranial direct current stimulation (tDCS) is a powerful and easy-to-use tool to modulate brain activity. Cathodal tDCS (c-tDCS) is assumed to decrease cortical excitability in the targeted brain region. We hypothesized that c-tDCS applied over the left OFC alleviates symptoms in patients with treatment-resistant OCD. We report here the case of a patient who received 10 sessions (2 mA, 20 minutes) of c-tDCS. The tDCS sessions were delivered twice a day with a 2-hour interval, with the cathode (35 cm²) placed over the left OFC and the anode (100 cm²) placed over the contralateral occipital region. No adverse event was reported. One month after the completion of the tDCS sessions, we observed a 26% reduction in severity of obsessive and compulsive symptoms measured using the Yale-Brown Obsessive Compulsive Scale scores. These findings are consistent with a previous study reporting a similar reduction in obsessive and compulsive symptoms after a low-frequency repetitive transcranial magnetic stimulation was given to the left OFC. Our results indicate that c-tDCS applied over the left OFC may be a suitable and safe treatment in patients with treatment-resistant OCD.
Polarity-dependent effects of transcranial direct current stimulation in obsessive-compulsive disorder. [2022]About one third of patients with obsessive-compulsive disorder (OCD) fail to experience significant clinical benefit from currently available treatments. Hyperactivity of the presupplementary motor area (pre-SMA) has been detected in OCD patients, but it is not clear whether it is the primary cause or a secondary compensatory mechanism in OCD pathophysiology. Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique with polarity-dependent effects on motor cortical excitability. A 33-year-old woman with treatment-resistant OCD received 20 daily consecutive 2 mA/20 min tDCS sessions with the active electrode placed on the pre-SMA, according to the 10-20 EEG system, and the reference electrode on the right deltoid. The first 10 sessions were anodal, while the last 10 were cathodal. Symptoms severity was assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) severity score. In the end of anodal stimulation, OCD symptoms had worsened. Subsequent cathodal stimulation induced a dramatic clinical improvement, which led to an overall 30% reduction in baseline symptoms severity score on the Y-BOCS. Our study supports the hypothesis that pre-SMA hyperfunction might be responsible for OCD symptoms and shows that cathodal inhibitory tDCS over this area might be an option when dealing with treatment-resistant OCD.
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies.
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
[A pilot study of transcranial alternating current stimulation in the treatment of drug-naive adult patients with major depressive disorder]. [2020]Objective: To explore the efficacy, adverse reactions, feasibility, and acceptability of transcranial alternating current stimulation (tACS) treating drug-naive adult patients with major depressive disorder (MDD), and provide basis for further study with a large sample. Methods: The study was performed in the Neuromodulation laboratory, Department of Neurology of Xuanwu Hospital, Capital Medical University (Beijing, China) from July, 2017 to June, 2018. Thirty Eligible first-episode MDD outpatients were randomized 1∶1 to receive active tACS or sham intervention. The tACS was administered in a 40 minute, 77.5 Hz frequency, 15 mA session with one forehead (Fp1, Fpz, and Fp2, in the 10/20 international placement system, 4.45 cm×9.53 cm) and two mastoid (3.18 cm×3.81 cm) stimulation for 20 times in 4 consecutive weeks at fixed day time frame once daily from Monday through Friday, with weekends off (week 4), followed by 4 weeks with no tACS treatment (week 8). By utilizing the Hamilton rating scale for depression-17 item (HRSD-17) to assess the depressive severity of MDD patients, adverse events were administered by the treatment-emergent adverse events, the Young mania rating scale, and the self-made common questionnaire on cranial electrical stimulation. The primary efficacy outcome was the remission rate defined as HRSD-17 score ≤7 at week 8. Secondary outcomes included the rates of remission at week 4 and response at weeks 4 and 8. Safety was assessed by evaluation of adverse events. Also the proportions of participants accepting the intervention and this study procedure were evaluated at weeks 4 and 8. Results: Thirty MDD patients completed the study, and both groups had no statistical differences on their demographic characteristics (P>0.05). At week 8, the active group had a remission rate of 10/15, which was higher than 3/15 in the sham group (P<0.05). Also, the remission rate (14/15) in the active group was higher than 5/15 of the sham group at week 4 (P<0.05). For the response rates, significant differences were found between groups at week 8. For safety, both groups showed no severe adverse events and no mania/hypomania. One participant per group had 2 times of tinnitus cerebri during the intervention days. All patients accepted the intervention and the study procedure. Conclusions: The pilot study indicated that tACS with 77.5 Hz and 15 mA may have a therapeutic effect on depressive symptoms. It is well-tolerated and safe, as well as feasible and acceptable for adults with MDD.
Safety of transcranial direct current stimulation in healthy participants. [2021]•Transcranial Direct Current Stimulation (tDCS) is mostly reported as safe.•BUT it could induce life-changing conditions in healthy volunteers.•Scientific community MUST be warned that tDCS may be harmful and protect healthy volunteers.
Efficacy and safety of transcranial direct current stimulation as an add-on treatment for obsessive-compulsive disorder: a randomized, sham-controlled trial. [2023]Obsessive-compulsive disorder (OCD) is a frequent, disabling disorder with high rates of treatment resistance. Transcranial direct current stimulation (tDCS) is a safe, tolerable noninvasive neuromodulation therapy with scarce evidence for OCD. This double-blind, randomized, and sham-controlled study investigates the efficacy of tDCS as add-on treatment for treatment-resistant OCD (failure to respond to at least one previous pharmacological treatment). On 20 consecutive weekdays (4 weeks), 43 patients with treatment-resistant OCD underwent 30 min active or sham tDCS sessions, followed by a 8 week follow-up. The cathode was positioned over the supplementary motor area (SMA) and the anode over the left deltoid. The primary outcome was the change in baseline Y-BOCS score at week 12. Secondary outcomes were changes in mood and anxiety and the occurrence of adverse events. Response was evaluated considering percent decrease of baseline Y-BOCS scores and the Improvement subscale of the Clinical Global Impression (CGI-I) between baseline and week 12. Patients that received active tDCS achieved a significant reduction of OCD symptoms than sham, with mean (SD) Y-BOCS score changes of 6.68 (5.83) and 2.84 (6.3) points, respectively (Cohen's d: 0.62 (0.06-1.18), p = 0.03). We found no between-group differences in responders (four patients in the active tDCS and one in the sham group). Active tDCS of the SMA was not superior to sham in reducing symptoms of depression or anxiety. Patients in both groups reported mild adverse events. Our results suggest that cathodal tDCS over the SMA is an effective add-on strategy in treatment-resistant OCD.
Feasibility and acceptability of transcranial stimulation in obsessive-compulsive symptoms (FEATSOCS): study protocol for a randomised controlled trial of transcranial direct current stimulation (tDCS) in obsessive-compulsive disorder (OCD). [2021]Obsessive-compulsive disorder (OCD) is a neuropsychiatric disorder which often proves refractory to current treatment approaches. Transcranial direct current stimulation (tDCS), a noninvasive form of neurostimulation, with potential for development as a self-administered intervention, has shown potential as a safe and efficacious treatment for OCD in a small number of trials. The two most promising stimulation sites are located above the orbitofrontal cortex (OFC) and the supplementary motor area (SMA).
Transcranial direct current stimulation for treatment-resistant obsessive-compulsive disorder: report on two cases and proposal for a randomized, sham-controlled trial. [2022]Neuromodulation techniques for treating obsessive-compulsive disorder (OCD) have expanded through greater understanding of the brain circuits involved in this disorder. Transcranial direct current stimulation (tDCS), a non-invasive technique, has been studied as an alternative for treatment-resistant OCD. We describe the design of a clinical trial using tDCS for OCD and report on the outcomes from two patients with primary OCD who were resistant to cognitive-behavioral therapy and to selective serotonin reuptake inhibitors, and who received tDCS in an open manner during the training phase for the study procedures.
Neuromodulation for obsessive-compulsive disorder. [2021]Neuromodulation shows increasing promise in the treatment of psychiatric disorders, particularly obsessive-compulsive disorder (OCD). Development of tools and techniques including deep brain stimulation, transcranial magnetic stimulation, and electroconvulsive therapy may yield additional options for patients who fail to respond to standard treatments. This article reviews the motivation for and use of these treatments in OCD. We begin with a brief description of the illness followed by discussion of the circuit models thought to underlie the disorder. These circuits provide targets for intervention. Basal ganglia and talamocortical pathophysiology, including cortico-striato-thalamo-cortical loops is a focus of this discussion. Neuroimaging findings and historical treatments that led to the use of neuromodulation for OCD are presented. We then present evidence from neuromodulation studies using deep brain stimulation, electroconvulsive therapy, and transcranial magnetic stimulation, with targets including nucleus accumbens, subthalamic nucleus inferior thalamic peduncle, dorsolateral prefrontal cortex, supplementary motor area, and orbitofrontal cortex. Finally, we explore potential future neuromodulation approaches that may further refine and improve treatment.
Transcranial direct current stimulation in obsessive-compulsive disorder: emerging clinical evidence and considerations for optimal montage of electrodes. [2022]Neuromodulation techniques for obsessive-compulsive disorder (OCD) treatment have expanded with greater understanding of the brain circuits involved. Transcranial direct current stimulation (tDCS) might be a potential new treatment for OCD, although the optimal montage is unclear.