Transcranial Direct Current Stimulation for OCD

Overseen By Ava Reker, B.A.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Anxiolytics, Psychotropics

Disqualifiers: Substance use, Suicidality, Bipolar, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores transcranial direct current stimulation (tDCS), a gentle electrical nudge to the brain, to determine its effectiveness for people with obsessive-compulsive disorder (OCD). The researchers aim to discover if tDCS can enhance brain connections and help individuals manage their fears more effectively. Participants with significant OCD symptoms for at least a year, whether on stable psychiatric treatment or not receiving active treatment, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for OCD.

Will I have to stop taking my current medications?

The trial requires that participants have stable psychiatric treatment for at least 8 weeks or no active treatment. Active use of anxiolytic medications (like benzodiazepines) is not allowed, so you may need to stop taking those.

What prior data suggests that transcranial direct current stimulation is safe for OCD?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated. A review found that tDCS can help reduce symptoms of OCD, along with related depression and anxiety, without causing major side effects. Another study confirmed that tDCS is safe for treating OCD in teenagers. While more research is needed, these findings suggest that tDCS is a promising and safe treatment for OCD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for OCD because it offers a non-invasive approach that targets brain activity directly. Unlike standard treatments like cognitive-behavioral therapy or medication such as SSRIs, which can take weeks to show effects, tDCS has the potential to produce faster results. This method involves applying a gentle electrical current to specific areas of the brain, which may help modulate neural circuits involved in OCD, offering a new avenue for those who may not respond well to traditional therapies.

What evidence suggests that transcranial direct current stimulation is effective for OCD?

This trial will compare active transcranial direct current stimulation (tDCS) with sham stimulation for treating OCD. Studies have shown mixed results for using tDCS to treat OCD. One study found that people who received real tDCS treatment experienced a noticeable reduction in OCD symptoms after ten sessions compared to those who received a fake treatment. However, a review of several studies has found that it's still unclear if tDCS is an effective treatment for OCD, and larger studies are needed. Another analysis suggested that tDCS can strongly improve certain OCD symptoms, but the results are not consistent. Overall, while tDCS shows promise, more research is needed to confirm its effectiveness in treating OCD. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with Obsessive-Compulsive Disorder (OCD) or Obsessive Compulsive Personality Disorder who are looking to participate in a study involving brain stimulation techniques aimed at improving their condition.

Inclusion Criteria

Participants must meet criteria for OCD as determined by structured clinical interview

I currently have severe OCD symptoms.

Participants must be able to provide written and verbal informed consent

Exclusion Criteria

Participants must not have active severe substance use disorder(s)

I am not taking any medications for mental health issues.

Participants must not have acute suicidality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline and Conditioning

Participants complete baseline screening, clinical characterization, and fear conditioning procedures with fMRI and measures of fearful responding

1 day

1 visit (in-person)

Extinction Training and tDCS

Participants undergo extinction training and receive either active or sham transcranial direct current stimulation (tDCS) with fMRI monitoring

1 day

1 visit (in-person)

Return of Fear Testing

Participants complete return of fear testing including spontaneous recovery, context renewal, and reinstatement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview The study is testing the effects of transcranial direct current stimulation (tDCS), a non-invasive brain stimulation method, on extinction learning—a key component of therapeutic exposure—in patients with OCD.

How Is the Trial Designed?

Group I: Active transcranial direct current stimulation Active Control 1 Intervention

Current will be ramped in/out for 30 seconds at the beginning and end of a 20-minute period and a constant current will be delivered for the 20-minutes between ramping.

Group II: Sham transcranial direct current stimulation Placebo Group 1 Intervention

Current will be ramped in and out for 30 seconds followed by a 20-minute period during which no stimulation will be delivered.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

This feasibility study involves 25 adults with OCD and aims to assess the acceptability and safety of transcranial direct current stimulation (tDCS) as a treatment, focusing on two stimulation sites: the orbitofrontal cortex (OFC) and the supplementary motor area (SMA).

The study will evaluate the effectiveness of tDCS on OCD symptoms and gather qualitative data on participants' experiences, which will help refine the methodology for a larger trial, indicating potential for tDCS as a self-administered intervention for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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). Cinosi, E., Adam, D., Aslan, I., et al.[2021]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

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]

A case study of a patient with treatment-resistant OCD showed that 10 sessions of cathodal transcranial direct current stimulation (c-tDCS) over the left orbitofrontal cortex led to a 26% reduction in obsessive and compulsive symptoms, indicating potential efficacy.

The treatment was safe, with no adverse events reported, suggesting that c-tDCS could be a viable option for patients who do not respond to traditional OCD therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Cathodal Transcranial Direct Current Stimulation Over the Left Orbitofrontal Cortex in a Patient With Treatment-Resistant Obsessive-Compulsive Disorder. Mondino, M., Haesebaert, F., Poulet, E., et al.[2022]

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]

Transcranial direct current stimulation (tDCS) is a promising non-invasive treatment for patients with treatment-resistant obsessive-compulsive disorder (OCD), as shown in a clinical trial design involving 44 participants.

In initial case reports, one patient experienced significant improvement in OCD symptoms after tDCS treatment, while another did not respond, indicating variability in treatment efficacy; however, tDCS was well tolerated overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for treatment-resistant obsessive-compulsive disorder: report on two cases and proposal for a randomized, sham-controlled trial. Silva, RM., Brunoni, AR., Miguel, EC., et al.[2022]

In a study involving 24 OCD patients, 10 sessions of high-definition transcranial direct current stimulation (tDCS) significantly reduced OCD symptoms, as measured by the Yale-Brown Obsessive-Compulsive Scale, along with improvements in depression and anxiety scores.

The treatment also led to a notable decrease in TMS-evoked N100 amplitude, suggesting a modulation of GABAB receptor function, which was initially higher in OCD patients compared to healthy controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation improve symptoms and modulates cortical inhibition in obsessive-compulsive disorder: A TMS-EEG study. Cheng, J., Li, P., Tang, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11212764/

Transcranial direct current stimulation as early ... Cathodal stimulation over the supplementary motor area produces insignificant improvement in severity of OCD than sham controls.

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/39173783/

A systematic review and meta-analysis for the efficacy of ... This finding diminishes the promise of tDCS as an effective treatment for OCD. Larger trials are warranted to further elucidate these findings.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04106102

Study of the Effectiveness of Transcranial Direct Current ... We propose to study the efficacy and tolerability of tDCS in the treatment of drug-resistant OCD in a in a randomized, controlled, prospective, double-blind ...

5. 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) ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06834217?aggFilters=status%3Anot%2Cphase%3A

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

9. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-020-02979-1

a randomized, double-blind, sham-controlled, clinical trial This study aimed to assess the safety and efficacy of transcranial direct current stimulation (tDCS) as adjunctive therapy with fluoxetine in ...