What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include medications like selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). SSRIs can cause side effects such as nausea, headache, drowsiness, and sexual dysfunction. Cognitive-behavioral therapy generally has fewer side effects but can sometimes cause increased anxiety or emotional discomfort during sessions. Transcranial Magnetic Stimulation (TMS), a non-invasive brain stimulation technique, has shown promise in treating OCD. The side effects of TMS are generally mild and may include headaches, scalp discomfort at the stimulation site, tingling, and, rarely, seizures. Further studies are needed to fully establish the safety profile of TMS for OCD.

What prior FDA approvals exist?

Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technique that uses magnetic fields to modulate neural activity. While TMS has shown promise in treating various psychiatric conditions, including depression and migraine, its use in Obsessive-Compulsive Disorder (OCD) is still under investigation. The FDA has approved TMS for the treatment of major depressive disorder and migraine, but specific FDA approval for OCD treatment with TMS is not mentioned. Other FDA-approved treatments for OCD primarily include pharmacological options such as selective serotonin reuptake inhibitors (SSRIs) and clomipramine, a tricyclic antidepressant. Cognitive-behavioral therapy (CBT), particularly exposure and response prevention (ERP), is also a well-established treatment for OCD.

What other types of research exist?

Promising novel alternatives to TMS for treating OCD include transcutaneous trigeminal nerve stimulation (TTNS) and neurofeedback. TTNS has shown potential in modulating neural activity and improving symptoms in various psychiatric conditions. Neurofeedback, which involves training patients to alter their brain activity, has also been reviewed for its efficacy in pediatric ADHD and may hold promise for OCD treatment.

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Neuromodulation

Targeted Neuromodulation for Obsessive-Compulsive Disorder

N/A

Recruiting

Led By Brian P Brennan, MD

Research Sponsored by Mclean Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DSM-5 diagnosis of OCD as primary presenting disorder

Male or female age 18-55 years old

Must not have

Use of psychiatric medications other than permitted above

History of traumatic brain injury, seizure disorder, neurodegenerative disease, or other organic brain disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Summary

This trial investigates whether a magnetic treatment can help people with OCD who have contamination/washing symptoms. The treatment uses magnetic fields to stimulate brain cells and aims to reduce overactivity in specific brain areas to alleviate these symptoms. This method has been approved for treating depression and OCD.

Who is the study for?

This trial is for adults aged 18-55 with Obsessive-Compulsive Disorder (OCD), specifically those who struggle mainly with contamination/washing symptoms. Participants should score ≥8 on a specific OCD scale and not have started new therapy or changed medications recently. It's not open to individuals using certain psychiatric drugs, those with a recent substance use disorder, or anyone pregnant.

What is being tested?

The study tests individually targeted neuromodulation techniques: iTBS and cTBS against a sham procedure to see if they can reduce contamination-based OCD symptoms more effectively than current general treatments.

What are the potential side effects?

While the description doesn't specify side effects, transcranial magnetic stimulation can sometimes cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My main diagnosis is OCD according to DSM-5.

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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any psychiatric medications not allowed in this study.

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I have a history of brain injury or disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional connectivity between R MFG and brain regions within VAN (expressed as a Z-score)

Secondary study objectives

Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS)

Functional activation of R MFG and brain regions within VAN during an RSVP task (expressed as a beta value)

Yale-Brown Obsessive Compulsive Scale (YBOCS)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: iTBSExperimental Treatment1 Intervention

intermittent TBS to right MFG

Group II: cTBSExperimental Treatment1 Intervention

continuous TBS to right MFG

Group III: shamPlacebo Group1 Intervention

sham stimulation to right MFG

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iTBS

2019

Completed Phase 3

~640

cTBS

2013

N/A

~50

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Obsessive-Compulsive Disorder (OCD) treatments primarily include pharmacological approaches like selective serotonin reuptake inhibitors (SSRIs) and non-pharmacological methods such as Cognitive Behavioral Therapy (CBT). SSRIs work by increasing serotonin levels in the brain, which helps reduce OCD symptoms. CBT aims to change maladaptive thought patterns and behaviors. Transcranial Magnetic Stimulation (TMS), a non-invasive brain stimulation technique, uses magnetic fields to modulate neural activity in specific brain regions like the supplementary motor area or the orbitofrontal cortex. This modulation can decrease the hyperactivity in these areas, which is often linked to OCD symptoms. Understanding these mechanisms is important for OCD patients as it helps them comprehend how different treatments can alleviate their symptoms and improve their overall well-being.

[Repetitive transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder].