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

180 Participants Needed

Trial Summary

What is the purpose of this trial?

Obsessive-compulsive disorder (OCD) is associated with substantial impairments in quality of life and is among the most disabling psychiatric disorders. Exposure therapy is among the first-line of treatments for obsessive-compulsive disorder (OCD) . Extinction learning is thought to be a core mechanism of therapeutic exposure. Fear and safety signal learning are traditionally associated with activity and connectivity within the canonical corticolimbic "fear circuit", which includes the amygdala, medial prefrontal cortex (mPFC), and hippocampus. Transcranial direct current stimulation (tDCS) is a neuromodulation technology that can augment brain plasticity, learning, and memory. The proposed study will test if obsessive-compulsive disorder (OCD) is associated with inhibitory safety learning deficits and if transcranial direct current stimulation (tDCS) normalizes functional connectivity and safety signal processing to recover extinction deficits in obsessive-compulsive disorder (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 data supports the effectiveness of the treatment Transcranial Direct Current Stimulation for OCD?

Transcranial Direct Current Stimulation (tDCS) has shown promise in improving symptoms of OCD, as well as depression and anxiety, in patients who did not respond to other treatments. Although the evidence is limited and more research is needed, some studies suggest it could be a safe and effective option. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe, with most studies reporting only mild and temporary side effects like itching, tingling, and headaches. However, there are concerns about potential risks, and some studies suggest it could cause significant issues, so caution is advised. ^{3 6 7 8 9}

How does transcranial direct current stimulation (tDCS) differ from other treatments for OCD?

Transcranial direct current stimulation (tDCS) is a unique treatment for OCD because it is a non-invasive brain stimulation technique that uses a weak electrical current to modulate brain activity, specifically targeting areas like the orbitofrontal cortex. Unlike traditional medications or therapies, tDCS can be self-administered and has shown promise in improving symptoms in patients who do not respond to standard treatments. ^{1 2 4 6 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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]

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 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]

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) 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]

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]

References

1. Brazil 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. [2022]

2. England 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). [2021]

3. 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]

4. Germany pubmed.ncbi.nlm.nih.gov

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Netherlands pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation improve symptoms and modulates cortical inhibition in obsessive-compulsive disorder: A TMS-EEG study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

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

Efficacy of Cathodal Transcranial Direct Current Stimulation Over the Left Orbitofrontal Cortex in a Patient With Treatment-Resistant Obsessive-Compulsive Disorder. [2022]