Obsessive-Compulsive DisorderNCT05048251
Individually Targeted Neuromodulation for Contamination-based OCD
A study testing cTBS and iTBS in people with Obsessive-Compulsive Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- cTBS and iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Brian P Brennan, MD, 617-855-2911, bbrennan@partners.org
About this study
Official title: Individually Targeted Neuromodulation for Contamination-based Obsessive-compulsive Disorder
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.
Read the detailed description
The symptoms of obsessive-compulsive disorder (OCD) appear linked to dysfunction in a cortico-striato-thalamo-cortical circuit. However, obsessions and compulsions vary widely among OCD patients, suggesting that other symptom-specific brain networks may accompany this core defect. Identifying such networks could lead to personalized treatments, improving upon current "one size fits all" approaches.
Factor analyses have found distinct symptom dimensions in OCD, but the neural systems specific to these dimensions remain unclear. Using a novel, data-driven, individual-level approach to resting-state functional connectivity magnetic resonance imaging (fcMRI), the investigators have shown that increased connectivity between right medial frontal gyrus (R MFG) and brain regions within the ventral attention network (VAN) - regions critical to reorienting attention in response to relevant external stimuli - specifically predicted the severity of contamination/washing (CONTAM) symptoms, and attenuation of this hyperconnectivity following treatment was associated with improvement in CONTAM symptoms. Based on these findings, the investigators hypothesize that decreasing R MFG-VAN connectivity via transcanial magnetic stimulation (TMS) will normalize attentional reorienting and reduce CONTAM symptoms in individuals with contamination-based OCD.
The investigators propose a two-phase program to investigate R MFG-targeted TMS as a potential intervention for contamination-based OCD. First, in the currently study, the investigators will determine the optimal TMS paradigm to decrease R MFG-VAN connectivity by administering continuous, intermittent, and sham theta burst stimulation (cTBS, iTBS, sham) to individuals with contamination-based OCD using a novel individual-level approach to target the area of R MFG most strongly correlated with VAN based on each participant's pre-treatment connectivity data. Second, the investigators will use the TMS approach identified in this study to test the links between reduced R MFG-VAN connectivity, decreased VAN activation during attentional reorienting, and reduced CONTAM symptoms in a future study using a larger sample of OCD individuals with CONTAM.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- cTBS, iTBS, sham
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cTBSDevice
continuous theta burst stimulation
iTBSDevice
intermittent theta burst stimulation
shamDevice
sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| cTBS | Experimental | continuous TBS to right MFG Receives: Device: cTBS |
| iTBS | Experimental | intermittent TBS to right MFG Receives: Device: iTBS |
| sham | Sham comparator | sham stimulation to right MFG Receives: Device: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity between R MFG and brain regions within VAN (expressed as a Z-score)
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
Measured: 6 weeks
Secondary outcomes (3)
Functional activation of R MFG and brain regions within VAN during an RSVP task (expressed as a beta value)
Change in activation in: 1) R MFG; 2) R TPJ; 3) L TPJ; 4) R IFG; 5) L IFG; 6) R AI; 7) L AI; 8) R posteromedial putamen; and 9) L posteromedial putamen during visual search on the RSVP task
Measured: 6 weeks
Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS)
Change in score on Category 4 (contamination) on the Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS) (minimum score: 0 and maximum score: 18; higher scores represent more severe symptoms)
Measured: 6 weeks
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Change in total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS) (minimum score: 0 and maximum score: 40; higher scores represent more severe symptoms)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Jul 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Brian P. Brennan, MD, Mclean Hospital
- Investigators
- Brian P Brennan, MD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048251
- Sponsor's protocol ID
- 2021P000141
- Status last verified
- Mar 2024
- First submitted
- 27 Aug 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individually Targeted Neuromodulation for Contamination-based Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT05048251
- Acronym / sponsor ID
- 2021P000141
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The symptoms of obsessive-compulsive disorder (OCD) appear linked to dysfunction in a cortico-striato-thalamo-cortical circuit. However, obsessions and compulsions vary widely among OCD patients, suggesting that other symptom-specific brain networks may accompany this core defect. Identifying such networks could lead to personalized treatments, improving upon current "one size fits all" approaches.
Factor analyses have found distinct symptom dimensions in OCD, but the neural systems specific to these dimensions remain unclear. Using a novel, data-driven, individual-level approach to resting-state functional connectivity magnetic resonance imaging (fcMRI), the investigators have shown that increased connectivity between right medial frontal gyrus (R MFG) and brain regions within the ventral attention network (VAN) - regions critical to reorienting attention in response to relevant external stimuli - specifically predicted the severity of contamination/washing (CONTAM) symptoms, and attenuation of this hyperconnectivity following treatment was associated with improvement in CONTAM symptoms. Based on these findings, the investigators hypothesize that decreasing R MFG-VAN connectivity via transcanial magnetic stimulation (TMS) will normalize attentional reorienting and reduce CONTAM symptoms in individuals with contamination-based OCD.
The investigators propose a two-phase program to investigate R MFG-targeted TMS as a potential intervention for contamination-based OCD. First, in the currently study, the investigators will determine the optimal TMS paradigm to decrease R MFG-VAN connectivity by administering continuous, intermittent, and sham theta burst stimulation (cTBS, iTBS, sham) to individuals with contamination-based OCD using a novel individual-level approach to target the area of R MFG most strongly correlated with VAN based on each participant's pre-treatment connectivity data. Second, the investigators will use the TMS approach identified in this study to test the links between reduced R MFG-VAN connectivity, decreased VAN activation during attentional reorienting, and reduced CONTAM symptoms in a future study using a larger sample of OCD individuals with CONTAM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cTBS | Experimental | Device: cTBScontinuous TBS to right MFG |
| iTBS | Experimental | Device: iTBSintermittent TBS to right MFG |
| sham | Sham comparator | Device: shamsham stimulation to right MFG |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cTBScontinuous theta burst stimulation | Device | cTBS |
| iTBSintermittent theta burst stimulation | Device | iTBS |
| shamsham stimulation | Device | sham |
Primary outcome
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
3 secondary outcomes
Functional activation of R MFG and brain regions within VAN during an RSVP task (expressed as a beta value)
Time frame: 6 weeks
Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS)
Time frame: 6 weeks
Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian P Brennan, MD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cTBS and iTBS in people with Obsessive-Compulsive Disorder, run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosalind Sokoll (617-855-2911, rsokoll@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity between R MFG and brain regions within VAN (expressed as a Z-score) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.