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

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators want to learn more about how human beings learn not to fear and the impact of changing the fear network in the brain using transcranial Direct Current Stimulation (tDCS) in individuals with obsessive compulsive disorder (OCD). The investigators hope this study will help us understand how future treatments can help patients with OCD better control unwanted fear.

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 safety data exists for tDCS treatment?

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, with no reports of serious adverse effects or irreversible injury in human trials using conventional protocols (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) across over 33,200 sessions and 1000 subjects, including vulnerable populations. Adverse events are typically low and transient. However, some caution is advised as there are concerns about potential risks in healthy volunteers. ^{1 2 3 4 5}

Is tDCS a promising treatment for Obsessive-Compulsive Disorder?

Yes, tDCS is a promising treatment for Obsessive-Compulsive Disorder, especially for patients who do not respond to traditional treatments. It has shown potential in reducing OCD symptoms, as well as related depression and anxiety. ^{5 6 7 8 9}

What data supports the idea that tDCS for Obsessive-Compulsive Disorder is an effective treatment?

The available research shows that transcranial direct current stimulation (tDCS) may help reduce symptoms in people with Obsessive-Compulsive Disorder (OCD) who do not respond to other treatments. Studies have reported improvements in OCD symptoms, as well as in depression and anxiety, in patients who are resistant to traditional therapies. However, these findings are based on a limited number of studies with small groups of participants, and more research is needed to confirm these results. ^{5 6 7 8 10}

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for treatment-resistant obsessive-compulsive disorder-A large case series. [2021]

2. Iran pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation on Dorsolateral Prefrontal Cortex to Reduce the Symptoms of the Obsessive-Compulsive Disorder. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder: A Systematic Review. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in patients with obsessive compulsive disorder: A randomized controlled trial. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

[Transcranial direct current stimulation (tDCS) for obsessive-compulsive disorder: A new treatment option?] [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability and practicality of transcranial stimulation in obsessive compulsive symptoms (FEATSOCS): A randomised controlled crossover trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Immediate Effects of Transcranial Direct Current Stimulation on Obsession-Induced Anxiety in Refractory Obsessive-Compulsive Disorder: A Pilot Study. [2019]