Neuromodulation for Obsessive-Compulsive Disorder

Overseen By Robert Reinhart, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Bipolar, Psychotic disorders, Tourette, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new, non-invasive treatment called high-definition transcranial alternating current stimulation (HD-tACS) for people with obsessive-compulsive disorder (OCD). The goal is to quickly reduce OCD symptoms with fewer side effects by targeting brain rhythms linked to reward and decision-making. Participants who may qualify have OCD as their primary diagnosis and have not seen improvement with other treatments. The trial includes both active and sham (placebo) treatment groups to compare results. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to innovative OCD treatments.

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 prior data suggests that this neuromodulation method is safe for OCD patients?

Research has shown that high-definition transcranial alternating current stimulation (HD-tACS) could be a promising treatment for obsessive-compulsive disorder (OCD). Early results suggest it reduces OCD symptoms quickly, with effects lasting up to three months. Studies indicate that this method is safe and generally well-tolerated, meaning it usually doesn't cause serious problems for patients.

One study found that similar brain stimulation techniques improved OCD symptoms. Another study highlighted that this treatment is unique because it uses alternating electric currents to target specific brain areas. This approach is non-invasive, meaning it doesn’t involve surgery or entering the body.

While more research is needed, current studies show that HD-tACS is generally safe for humans. It offers a potential new way to manage OCD symptoms with minimal side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about High Definition Transcranial Alternating Current Stimulation (HD-tACS) for Obsessive-Compulsive Disorder (OCD) because it offers a novel approach compared to traditional treatments like SSRIs and cognitive-behavioral therapy. Unlike these methods, HD-tACS targets the brain non-invasively using electrical currents to modulate neural activity in specific areas linked to OCD symptoms. This technique has the potential to provide quicker symptom relief and fewer side effects since it does not rely on medications or intensive behavioral interventions. By directly influencing brain circuits associated with OCD, researchers hope HD-tACS could become an effective alternative or complement to existing therapies.

What evidence suggests that this neuromodulation method is effective for OCD?

Research has shown that high-definition transcranial alternating current stimulation (HD-tACS) can help reduce OCD symptoms. In this trial, participants will join either the Active HD-tACS arm or the Sham HD-tACS arm. Earlier studies revealed that patients receiving a similar brain stimulation method, tDCS, experienced a noticeable decrease in symptoms compared to those receiving a placebo. Another study found that beta-gamma tACS improved symptoms more than alpha-tACS, suggesting that certain frequencies might be crucial for success. Additionally, a six-week course of personalized alpha-tACS targeting specific brain areas improved OCD symptoms. These findings suggest that HD-tACS, which targets the brain's reward and decision-making areas, could quickly reduce OCD symptoms with few side effects. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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

Score of 16 or greater on the YBOCS

Willingness and ability to provide informed consent and comply with the requirements of the study protocol

I have been diagnosed with OCD.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• High Definition Transcranial Alternating Current Stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Active HD-tACS Active Control 1 Intervention

HD-tACS of OFC

Group II: Sham HD-tACS Placebo Group 1 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

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

Published Research Related to This Trial

In a clinical trial involving 21 treatment-resistant OCD patients, cathodal transcranial direct current stimulation (tDCS) over the supplementary motor area showed a significant reduction in obsessive-compulsive symptoms after one month, with 24% of patients meeting the criteria for treatment response.

The treatment was well tolerated, with only mild side effects like tingling and skin redness reported, indicating that tDCS could be a safe and promising option for patients who do not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating refractory obsessive-compulsive disorder with transcranial direct current stimulation: An open label study. Harika-Germaneau, G., Heit, D., Chatard, A., et al.[2021]

Neuromodulation techniques like deep brain stimulation, transcranial magnetic stimulation, and electroconvulsive therapy are emerging as promising treatments for obsessive-compulsive disorder (OCD), especially for patients who do not respond to standard therapies.

These treatments target specific brain circuits involved in OCD, such as the basal ganglia and cortico-striato-thalamo-cortical loops, suggesting a mechanistic approach to improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation for obsessive-compulsive disorder. Lapidus, KA., Stern, ER., Berlin, HA., et al.[2021]

Transcranial direct current stimulation (tDCS) shows potential as a treatment for obsessive-compulsive disorder (OCD), particularly with a montage that places the cathode over the pre-supplementary motor area, which may effectively target brain areas involved in OCD.

The study reviewed existing literature on repetitive transcranial magnetic stimulation (rTMS) and deep brain stimulation (DBS) for OCD, using computer modeling to suggest optimal electrode placements for future tDCS trials, although further empirical validation is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in obsessive-compulsive disorder: emerging clinical evidence and considerations for optimal montage of electrodes. Senço, NM., Huang, Y., D'Urso, G., et al.[2022]

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]

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]

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]

A case study of a 33-year-old woman with treatment-resistant OCD showed that cathodal transcranial direct current stimulation (tDCS) over the presupplementary motor area (pre-SMA) led to a significant 30% reduction in OCD symptoms after 20 sessions, suggesting its potential as a treatment option.

The initial anodal stimulation worsened OCD symptoms, indicating that the pre-SMA may be hyperactive in OCD, and that inhibitory stimulation (cathodal) could be necessary to alleviate symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polarity-dependent effects of transcranial direct current stimulation in obsessive-compulsive disorder. D'Urso, G., Brunoni, AR., Anastasia, A., 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) 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]

In a pilot study involving 30 drug-naive adults with major depressive disorder, transcranial alternating current stimulation (tACS) at 77.5 Hz and 15 mA showed a significant remission rate of 10 out of 15 patients at week 8, compared to only 3 out of 15 in the sham group.

The tACS treatment was well-tolerated with no severe adverse events reported, indicating it is a safe and acceptable intervention for treating depressive symptoms in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A pilot study of transcranial alternating current stimulation in the treatment of drug-naive adult patients with major depressive disorder]. Wang, HX., Wang, K., Sun, ZC., et al.[2020]

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 43 patients with treatment-resistant OCD, transcranial direct current stimulation (tDCS) significantly reduced OCD symptoms compared to sham treatment, with an average decrease in Y-BOCS scores of 6.68 points for active tDCS versus 2.84 points for sham.

While tDCS was effective in reducing OCD symptoms, it did not show superiority in alleviating symptoms of depression or anxiety, and both groups reported only mild adverse events, indicating a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcranial direct current stimulation as an add-on treatment for obsessive-compulsive disorder: a randomized, sham-controlled trial. Silva, RMFD., Brunoni, AR., Goerigk, S., et al.[2023]

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]

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]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9337719/

Transcranial alternating current stimulation for the treatment of ... Beta-gamma tACS outperformed alpha-tACS in terms of symptom improvements, leading the authors to propose that such an intervention could be investigated in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04106102

Study of the Effectiveness of Transcranial Direct Current ... transcranial Direct current stimulation (tDCS) has already proven its effectiveness, in addition to drug approaches, in various clinical settings, such as ...

4. link.springer.com link.springer.com/article/10.1007/s00406-020-01209-9

Transcranial alternating current stimulation (tACS) tACS is a unique form of non-invasive brain stimulation. Sinusoidal alternating electric currents are delivered to the scalp to affect mostly cortical neurons.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2023/9958884

Home‐Based Individualized Alpha Transcranial Alternating ... Our findings suggest that a six-week, home-based treatment course of individualized alpha-tACS targeting the mPFC is capable of improving OCD symptoms.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7867505/

Transcranial alternating current stimulation (tACS): from basic ... tACS is a unique form of non-invasive brain stimulation. Sinusoidal alternating electric currents are delivered to the scalp to affect mostly cortical neurons.