Obsessive-Compulsive DisorderNCT04165577
Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study
A study testing rTMS in people with Obsessive-Compulsive Disorder, run by Butler Hospital at 1 site in United States.
Trial summary
This study investigates whether slow-frequency repetitive transcranial magnetic stimulation targeting frontal pole can acutely modulate brain circuits which show abnormal functioning during behavioral flexibility in obsessive-compulsive disorder, as well as performance on a behavioral task. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2019to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- current primary diagnosis of obsessive-compulsive disorder and Yale-Brown Obsessive Compulsive Scale total score ≥ 16;
- 18-55 years of age;
- ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
- either no use of psychiatric medication or stable psychiatric medication use for 6 weeks prior to study entry, limited to use of serotonin reuptake inhibitors and PRN use of benzodiazepines (other psychiatric medication use excluded), and
- right-handed.
- 18-55 years of age;
- ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
- right-handed.
Who cannot join
- active problematic substance use;
- lifetime psychosis or bipolar mood disorder or OCD beliefs of delusional nature;
- clinically significant hoarding symptoms;
- active suicidal or homicidal ideation;
- significant neurological disease or intracranial pathology;
- use of medications which increase risk for seizures during TMS;
Show all 14Show fewer
- significant or unstable medical disorders or contraindication to TMS or MRI scan.
- current psychiatric diagnosis;
- lifetime psychosis, bipolar mood disorder, or OCD;
- active suicidal or homicidal ideation;
- significant neurological disease or intracranial pathology;
- use of psychiatric medications;
- use of medications which increase risk for seizures during TMS;
- significant or unstable medical disorders or contraindication to TMS or MRI scan.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates whether slow-frequency repetitive transcranial magnetic stimulation targeting frontal pole can acutely modulate brain circuits which show abnormal functioning during behavioral flexibility in obsessive-compulsive disorder, as well as performance on a behavioral task.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- rTMS, sham rTMS
- 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.
rTMSDevice
1-Hz rTMS targeting frontal pole
sham rTMSDevice
sham rTMS targeting frontal pole
| Study group | Role | What they receive |
|---|---|---|
| OCD, Active TMS | Experimental | Participants with OCD who receive active rTMS Receives: Device: rTMS |
| OCD, Sham TMS | Sham comparator | Participants with OCD who receive sham rTMS Receives: Device: sham rTMS |
| Healthy Control, Active TMS | Other | Healthy control participants who receive active rTMS Receives: Device: rTMS |
| Healthy Control, Sham TMS | Other | Healthy control participants who receive sham rTMS Receives: Device: sham rTMS |
| Healthy Control, Active TMS (1 session) | Other | Healthy control participants who receive 1 session of active, open-label rTMS Receives: Device: rTMS |
| Healthy Control, Active TMS (3 sessions) | Other | Healthy control participants who receive 3 sessions of active, open-label rTMS Receives: Device: rTMS |
| OCD, Active TMS (3 session) | Other | Participants with OCD who receive 3 sessions of active, open-label rTMS Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-state functional connectivity with ventral striatum
Resting-state functional connectivity with ventral striatum (assessed via fMRI)
Measured: Before rTMS and approximately 1 day following open-label rTMS
Resting-state functional connectivity with dorsal striatum
Resting-state functional connectivity with dorsal striatum (assessed via fMRI)
Measured: Before rTMS and approximately 1 day following open-label rTMS
Cognitive flexibility task performance
Behavioral performance on a cognitive flexibility task (% trials correct)
Measured: Before rTMS and approximately 1 day following open-label rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start15 Nov 2019
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Garnaat, PhD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165577
- Sponsor's protocol ID
- 1901-003
- Status last verified
- Dec 2022
- First submitted
- 14 Nov 2019
- Last updated
- 13 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Prefrontal Circuits Underlying Behavioral Flexibility in OCD: A TMS Study
- ClinicalTrials.gov ID
- NCT04165577
- Acronym / sponsor ID
- 1901-003
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 18 Nov 2019 (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.
This study investigates whether slow-frequency repetitive transcranial magnetic stimulation targeting frontal pole can acutely modulate brain circuits which show abnormal functioning during behavioral flexibility in obsessive-compulsive disorder, as well as performance on a behavioral task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| OCD, Active TMS | Experimental | Device: rTMSParticipants with OCD who receive active rTMS |
| OCD, Sham TMS | Sham comparator | Device: sham rTMSParticipants with OCD who receive sham rTMS |
| Healthy Control, Active TMS | Other | Device: rTMSHealthy control participants who receive active rTMS |
| Healthy Control, Sham TMS | Other | Device: sham rTMSHealthy control participants who receive sham rTMS |
| Healthy Control, Active TMS (1 session) | Other | Device: rTMSHealthy control participants who receive 1 session of active, open-label rTMS |
| Healthy Control, Active TMS (3 sessions) | Other | Device: rTMSHealthy control participants who receive 3 sessions of active, open-label rTMS |
| OCD, Active TMS (3 session) | Other | Device: rTMSParticipants with OCD who receive 3 sessions of active, open-label rTMS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- current primary diagnosis of obsessive-compulsive disorder and Yale-Brown Obsessive Compulsive Scale total score ≥ 16;
- 18-55 years of age;
- ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
- either no use of psychiatric medication or stable psychiatric medication use for 6 weeks prior to study entry, limited to use of serotonin reuptake inhibitors and PRN use of benzodiazepines (other psychiatric medication use excluded), and
- right-handed.
Key exclusion criteria (14 listed)
- active problematic substance use;
- lifetime psychosis or bipolar mood disorder or OCD beliefs of delusional nature;
- clinically significant hoarding symptoms;
- active suicidal or homicidal ideation;
- significant neurological disease or intracranial pathology;
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 |
|---|---|---|
| rTMS1-Hz rTMS targeting frontal pole | Device | Healthy Control, Active TMS, Healthy Control, Active TMS (1 session), Healthy Control, Active TMS (3 sessions), OCD, Active TMS, OCD, Active TMS (3 session) |
| sham rTMSsham rTMS targeting frontal pole | Device | Healthy Control, Sham TMS, OCD, Sham TMS |
Primary outcome
Resting-state functional connectivity with ventral striatum
Time frame: Before rTMS and approximately 1 day following open-label rTMS
Resting-state functional connectivity with ventral striatum (assessed via fMRI)
Resting-state functional connectivity with dorsal striatum
Time frame: Before rTMS and approximately 1 day following open-label rTMS
Resting-state functional connectivity with dorsal striatum (assessed via fMRI)
Cognitive flexibility task performance
Time frame: Before rTMS and approximately 1 day following open-label rTMS
Behavioral performance on a cognitive flexibility task (% trials correct)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
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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. This study is not recruiting at the moment.
Sarah Garnaat, PhD principal investigator
Butler 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 rTMS in people with Obsessive-Compulsive Disorder, run by Butler 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 13 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting-state functional connectivity with ventral striatum (time frame: Before rTMS and approximately 1 day following open-label rTMS). The study lists 3 primary outcomes in all. 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 13 Dec 2022.