tDCS for Obsessive-Compulsive Disorder

Overseen By Ryan Jacoby, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Benzodiazepines

Disqualifiers: Head injury, Stroke, Pregnancy, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help people with obsessive-compulsive disorder (OCD) better manage their fears. It uses transcranial Direct Current Stimulation (tDCS), which involves a mild electrical current to influence brain activity related to fear. The trial tests tDCS at different times to determine its most effective application. Individuals with OCD causing moderate distress who can use a computer might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance OCD treatment options.

Do I have to stop taking my current medications for the trial?

You can continue most psychotropic medications like SSRIs and atypical antipsychotics. However, you must stop using benzodiazepines at least 2 weeks before the study and during the study.

What prior data suggests that transcranial Direct Current Stimulation (tDCS) is safe for individuals with obsessive-compulsive disorder (OCD)?

Research shows that transcranial Direct Current Stimulation (tDCS) is generally safe and easy to use. Studies have used tDCS without causing major side effects. Participants might experience mild tingling or itching on the scalp, but these sensations usually fade quickly.

While tDCS appears promising for conditions like OCD, the evidence is still developing. Some research suggests it might help with OCD, depression, and anxiety. However, more studies are needed to fully understand its effectiveness for OCD.

Overall, tDCS seems to be a safe option for many, with minor and temporary side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial Direct Current Stimulation (tDCS) for Obsessive-Compulsive Disorder (OCD) because it offers a non-invasive way to potentially modulate brain activity directly. Unlike standard OCD treatments, which typically include cognitive-behavioral therapy (CBT) or medications like SSRIs, tDCS involves administering a gentle electrical current to the brain, which might help in reducing symptoms more quickly. This technique is intriguing because it targets specific brain regions involved in fear and anxiety responses, potentially offering a faster and more targeted approach to treatment. Additionally, tDCS can be flexibly timed around different phases of symptom extinction, allowing researchers to explore the most effective timing for stimulation.

What evidence suggests that tDCS is effective for treating OCD?

Research has shown that transcranial Direct Current Stimulation (tDCS) can help reduce symptoms of obsessive-compulsive disorder (OCD). This trial will provide participants with various tDCS treatments, including active tDCS administered before, during, or after the extinction phase, or a sham tDCS treatment. One study found that patients who received real tDCS treatment experienced a significant decrease in their OCD symptoms compared to those who received a sham treatment. Another analysis revealed that tDCS had a strong effect in improving specific OCD symptoms, with noticeable improvement. Overall, these findings suggest that tDCS might help manage unwanted fears in OCD by influencing the brain's fear network. ^{4 5 6 7 8}

Who Is on the Research Team?

Joan Camprodon, MD, MPH, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with primary OCD causing moderate distress (Y-BOCS score ≥ 16). Participants should be comfortable using a computer. Excluded are those with significant head injuries, metal implants in the head/neck, pacemakers, pregnancy, epilepsy, recent substance abuse, history of mania or psychosis, resistance to multiple OCD treatments or use of benzodiazepines within two weeks.

Inclusion Criteria

Fluent in English, willing to provide informed consent, and willing to comply with the study protocol

My OCD causes significant distress or problems in my life.

Comfortable and capable of using a computer and completing computerized tasks

Exclusion Criteria

Current substance use disorder (within the past 12 months)

My vision problems could affect my participation.

I don't have metal implants, VP shunts, a pacemaker, am not pregnant, and don't have epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Habituation and Fear Conditioning

Participants undergo habituation and fear conditioning on Day 1

1 day

1 visit (in-person)

Extinction Learning

Participants undergo extinction learning on Day 1 with tDCS administered before, during, or after this phase

1 day

1 visit (in-person)

Extinction Recall and Reinstatement

Participants undergo extinction recall and reinstatement on Day 2

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview The study tests whether transcranial Direct Current Stimulation (tDCS) can help people with OCD overcome unwanted fear by altering brain activity. It compares active tDCS against sham (placebo) treatment to see if there's an improvement in managing fear.

How Is the Trial Designed?

Group I: Active tDCS administered during extinction phase Experimental Treatment 1 Intervention

The investigators will stimulate using 2mA of direct current during 20 min during the extinction phase of the fear conditioning and extinction paradigm.

Group II: Active tDCS administered before extinction phase Experimental Treatment 1 Intervention

The investigators will stimulate using 2mA of direct current during 20 min before the extinction phase of the fear conditioning and extinction paradigm.

Group III: Active tDCS administered after extinction phase Experimental Treatment 1 Intervention

The investigators will stimulate using 2mA of direct current during 20 min after the extinction phase of the fear conditioning and extinction paradigm.

Group IV: Sham tDCS Placebo Group 1 Intervention

Sham will consist of a ramp up and down of activity (from 0 to 2mA and back to 0mA) in the first 30sec and again in the last 30 sec of the 20min stimulation period (which will occur before/during/after the extinction phase). No active tDCS will occur.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Foundation for OCD Research

Collaborator

Trials

2

Recruited

480+

Published Research Related to This Trial

In a study of 32 patients with treatment-resistant obsessive-compulsive disorder (OCD), 28% showed at least a partial response to transcranial direct current stimulation (tDCS) after 10-20 sessions.

Among the responders, 25% had a significant improvement, suggesting that tDCS could be a beneficial treatment option for some individuals who do not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for treatment-resistant obsessive-compulsive disorder-A large case series. Thamby, A., Seshachala, K., Sharma, L., et al.[2021]

In a study involving 21 patients with treatment-resistant OCD, transcranial direct current stimulation (tDCS) showed a significant reduction in OCD symptoms immediately after treatment compared to sham stimulation.

However, the effects of tDCS did not persist, as there were no significant differences in symptom reduction observed one and three months after the treatment, indicating that while tDCS may provide short-term relief, it does not lead to long-lasting improvements in OCD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in patients with obsessive compulsive disorder: A randomized controlled trial. Bation, R., Mondino, M., Le Camus, F., et al.[2020]

Transcranial direct current stimulation (tDCS) shows promise in improving symptoms of treatment-resistant obsessive-compulsive disorder (OCD), with 78 patients reporting symptom relief, particularly in OCD, depression, and anxiety.

Current evidence is limited due to the absence of sham-controlled studies and the variability in stimulation parameters, highlighting the need for further research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation (tDCS) for obsessive-compulsive disorder: A new treatment option?] Palm, U., Brunelin, J., Wulf, L., et al.[2020]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

In a study involving 24 patients with Obsessive-Compulsive Disorder (OCD), transcranial Direct Current Stimulation (tDCS) applied to the Left Dorsolateral Prefrontal Cortex (DLPFC) resulted in significant symptom improvement, as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS).

The Left DLPFC group showed a mean difference of -6.18 in Y-BOCS scores compared to the sham group, indicating that tDCS may be an effective treatment option for reducing OCD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation on Dorsolateral Prefrontal Cortex to Reduce the Symptoms of the Obsessive-Compulsive Disorder. Shafiezadeh, S., Eshghi, M., Dokhaei, Z., et al.[2022]

In a study involving 12 patients with refractory obsessive-compulsive disorder (OCD), cathodal transcranial direct current stimulation (tDCS) significantly reduced obsession-induced anxiety immediately after exposure to provoking stimuli, compared to anodal and sham stimulation.

The anxiety reduction from cathodal tDCS was consistent but short-lived, suggesting it may be a useful tool for managing acute anxiety in OCD, although further research is needed to explore its long-term effects and potential integration with behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Effects of Transcranial Direct Current Stimulation on Obsession-Induced Anxiety in Refractory Obsessive-Compulsive Disorder: A Pilot Study. Todder, D., Gershi, A., Perry, Z., et al.[2019]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Transcranial direct current stimulation (tDCS) shows promise as a treatment for patients with treatment-resistant obsessive-compulsive disorder (OCD), with 77 patients in various studies reporting decreased symptoms, including comorbid depression and anxiety.

Current research lacks sham-controlled studies, highlighting the need for more rigorous trials to confirm the efficacy of tDCS and to standardize treatment parameters, as existing studies have methodological limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder: A Systematic Review. Brunelin, J., Mondino, M., Bation, R., et al.[2020]

Transcranial direct current stimulation (tDCS) is a safe and well-tolerated treatment for obsessive-compulsive disorder (OCD), with a study involving 20 adults showing good adherence and no serious adverse events.

The left orbitofrontal cortex (L-OFC) stimulation showed the greatest potential for reducing OCD symptoms, although the improvements were not statistically significant compared to sham treatment, indicating that further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial. Fineberg, NA., Cinosi, E., Smith, MVA., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39173783/

A systematic review and meta-analysis for the efficacy of ... These trials evaluated the efficacy of tDCS in OCD patients. Subsequent data extraction, risk of bias assessment, and statistical analysis using ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0010440X24000713

Results from a randomized, double-blind, controlled trial After the 10th session of tDCS treatment, the active stimulation group showed a significant reduction in obsessive-compulsive symptoms compared to the sham ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30808612/

A randomized, double blinded, sham controlled trial In this double blinded, randomized, sham controlled study, we investigated the efficacy of add-on transcranial direct current stimulation (tDCS) in reducing ...

4. nature.com nature.com/articles/s41398-024-03053-0

Immediate and long-term efficacy of transcranial direct ... Overall, the results of meta-analysis indicated that tDCS had a high effect in improving specific symptoms (SMD = −0.73, 95% CI: −1.09 to −0.37) ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06834217?cond=Obsessive%20Compulsive%20Disorder,%20OCD&aggFilters=funderType:nih,status:not%20rec%20act&rank=7

Transcranial Direct Current Stimulation and Extinction in ... The proposed study will test if obsessive-compulsive disorder (OCD) is associated with inhibitory safety learning deficits.

6. nature.com nature.com/articles/s41386-020-00928-w

Efficacy and safety of transcranial direct current stimulation ... Transcranial direct current stimulation (tDCS) is a safe, tolerable noninvasive neuromodulation therapy with scarce evidence for OCD. This ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S014976342500171X

Efficacy and safety of transcranial direct current stimulation ... This review suggests that tDCS may effectively alleviate OCD symptoms, along with related depression and anxiety, both acute and at follow-up, while causing ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34464485/

Transcranial direct current stimulation targeting the medial ... To examine the effects of tDCS on therapeutic safety learning, 24 patients with OCD completed a pilot randomized clinical trial; they were ...