NCT05048251 · Mclean Hospital
Individually Targeted Neuromodulation for Contamination-based OCD
What this study is about
Patients with obsessive-compulsive disorder (OCD) experience a wide array of different types of obsessions and compulsions. However, current treatments for OCD employ a "one size fits all" approach and are used for all patients regardless of symptom type.
View original scientific description
Patients with obsessive-compulsive disorder (OCD) experience a wide array of different types of obsessions and compulsions. However, current treatments for OCD employ a "one size fits all" approach and are used for all patients regardless of symptom type. In this project, the investigators propose to investigate whether a novel method of transcranial magnetic stimulation specifically reduces contamination/washing symptoms - one of the most common types of OCD.
Interventions
DEVICE
cTBS
continuous theta burst stimulation
DEVICE
iTBS
intermittent theta burst stimulation
DEVICE
sham
sham stimulation
Primary outcome measures
Functional connectivity between R MFG and brain regions within VAN (expressed as a Z-score)
Time frame: 6 weeks
Change in functional connectivity between: 1) R MFG and right temporoparietal junction (R TPJ); 2) R MFG and left temporoparietal junction (L TPJ); 3) R MFG and right inferior frontal gyrus (R IFG); 4) R MFG and left inferior frontal gyrus (L IFG); 5) R MFG and right anterior insula (R AI); 6) R MFG and left anterior insula (L AI); 7) R MFG and right posteromedial putamen; and 8) R MFG and left posteromedial putamen
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- male or female age 18-55 years old
- DSM-5 diagnosis of OCD as primary presenting disorder
- CONTAM as the predominant symptom dimension (i.e., Dimension 4 (CONTAM symptoms) is the highest score on the Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS); participants with more than one Dimension as highest score will still be eligible as long as Dimension 4 is one of these)
- score of ≥ 8 on Dimension 4 of the D-YBOCS
- taking no psychiatric medications or on a stable dose of an SSRI, clomipramine, SNRI, or second generation antipsychotic for at least 4 weeks prior to enrollment. Use of PRN benzodiazepines will be permitted as long as the dose/usage has not changed significantly leading up to enrollment. No medication changes will be permitted during the study
- have not initiated a new course of exposure and response prevention (ERP) therapy within 4 weeks of enrollment (ongoing ERP will be permitted if initiated more than 8 weeks before enrollment).
Exclusion criteria
- positive urine drug screen (other than prescribed benzodiazepines)
- use of psychiatric medications other than permitted above
- substance use disorder in the last 3 months (with the exception of nicotine)
- history of schizophrenia, bipolar disorder, autism, Tourette's syndrome (current and past history of depressive, anxiety, and eating disorders permitted as long as OCD is considered the primary disorder)
- active suicidal ideation over the week prior to screening (as indicated by answering yes to questions 1 or 2 on the C-SSRS)
- history of traumatic brain injury, seizure disorder, neurodegenerative disease, or other organic brain disease
- pregnancy or lactating
- contraindication to MRI scanning or TMS
Where
- Belmont, Massachusetts
Collaborators
Massachusetts General Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 15, 2024 · Source of record for eligibility and locations