Compulsive BehaviorNCT03265015
Theta Burst Stimulation for Compulsive Behavior Non-invasive Brain Stimulation Study
A study testing Habit Override Practice and Transcranial Magnetic Stimulation in people with Compulsive Behavior and Obsessive-Compulsive Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
This project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region in two directions (up or down) and measure effects on compulsive behaviors… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Compulsive Behavior, Obsessive-Compulsive Disorder
- What is being tested?
- Habit Override Practice and Transcranial Magnetic Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 30 Mar 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Participants will:
- Be between the ages of 18 and 55 years
- Endorse problematic compulsive behaviors, per self-report and clinician-administered measures.
- Agree to video taping of structured clinical interview
- Report that they will reside in the Pittsburgh area for at least 5 weeks
Who cannot join
- Failure to meet standard MRI inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. Pregnancy, determined by pregnancy tests on females.
- Medical contraindications for Transcranial Magnetic Stimulation (TMS):
- Presence of a neurologic disorder or medication therapy known to alter seizure threshold (e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches)
- Recurrent seizures or epilepsy in participant or family history of hereditary epilepsy
- Pregnancy
- Metallic implants in body or other devices that may be affected by magnetic field
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- Significant heart disease or cerebrovascular disease
- Medications with seizure threshold lowering potential, e.g., clomipramine, Monoamine Oxidase inhibitors (MAOi's), imipramine, clozapine
- Acute suicidality or other psychiatric crises requiring treatment escalation
- Changes made to treatment regimen within 4 weeks of baseline assessment
- Reading level <6th grade
- Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current use of mood altering drugs such as cocaine, cannabis or marijuana, opiates, amphetamines, and barbiturates)
- Presence of movement disorder or tics affecting manual responses
- Inability to read text from 2 feet away (corrective lenses allowed)
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Testing the Causal Role of Orbitofrontal Cortex in Human Compulsive Behavior: a Non-invasive Brain Stimulation Study
This project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region in two directions (up or down) and measure effects on compulsive behaviors and related measures. This work could ultimately lead to the ability to treat compulsions more effectively by targeting the regions of the brain that can help or hinder attempts to overcome compulsions.
- Conditions
- Compulsive Behavior, Obsessive-Compulsive Disorder
- Being tested
- Habit Override Practice, Transcranial Magnetic Stimulation
- Medical subject headings
- Compulsive Behavior, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habit Override PracticeBehavioural
Computerized "brain training" to provide practice in overriding avoidance habits.
Transcranial Magnetic StimulationOther
Non-invasive method for temporary, focal stimulation of brain areas.
| Study group | Role | What they receive |
|---|---|---|
| cTBS | Experimental | Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern. Receives: Behavioral: Habit Override Practice; Other: Transcranial Magnetic Stimulation |
| iTBS | Active comparator | Transcranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern. Receives: Behavioral: Habit Override Practice; Other: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional Magnetic Resonance Imaging (fMRI)
Brain activation in target region
Measured: 10-60min
Secondary outcomes (8)
Effort to resist compulsive behaviors in response to laboratory triggers
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist
Measured: 90min-1 week
Duration of compulsive behaviors in response to laboratory triggers
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance
Measured: 90min-1 week
Intensity of urges to perform compulsive behaviors in response to laboratory triggers
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity
Measured: 90min-1 week
Two-step task
Neuropsychological test of flexible goal-directed cognition
Measured: 90min-1 week
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Clinician-administered measurement of obsessions and compulsions
Measured: 1 week
WHO Disability Assessment Scale 2.0
Self-report measure of general functioning and disability
Measured: 1 week
Obsessive Compulsive Inventory-Revised (OCI-R)
Self-report measure of obsessions and compulsions
Measured: 1 week
Habit override task
Percentage of correct responses to each stimulus (0-100%; higher score=better performance)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start15 Sep 2017
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Compulsive BehaviorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rebecca Price, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265015
- Sponsor's protocol ID
- STUDY19090219 (Part 1)
- Other IDs
- R21MH112770
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2017
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data sharing and make use of NIMH databases.
Publications
Brown VM, Gillan CM, Renard M, Kaskie R, Degutis M, Wears A, Siegle GJ, Ferrarelli F, Ahmari SE, Price RB. A double-blind study assessing the impact of orbitofrontal theta burst stimulation on goal-directed behavior. J Psychopathol Clin Sci. 2022 Apr;131(3):287-300. doi: 10.1037/abn0000733. Epub 2022 Feb 7.
PubMed 35230864
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Causal Role of Orbitofrontal Cortex in Human Compulsive Behavior: a Non-invasive Brain Stimulation Study
- ClinicalTrials.gov ID
- NCT03265015
- Acronym / sponsor ID
- STUDY19090219 (Part 1)
- Conditions
- Compulsive Behavior, Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 29 Aug 2017 (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 project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region in two directions (up or down) and measure effects on compulsive behaviors and related measures. This work could ultimately lead to the ability to treat compulsions more effectively by targeting the regions of the brain that can help or hinder attempts to overcome compulsions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cTBS | Experimental | Behavioral: Habit Override Practice, Other: Transcranial Magnetic StimulationTranscranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern. |
| iTBS | Active comparator | Behavioral: Habit Override Practice, Other: Transcranial Magnetic StimulationTranscranial Magnetic Stimulation delivered in an intermittent Theta Burst Stimulation (iTBS) pattern. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be between the ages of 18 and 55 years
- Endorse problematic compulsive behaviors, per self-report and clinician-administered measures.
- Agree to video taping of structured clinical interview
- Report that they will reside in the Pittsburgh area for at least 5 weeks
Key exclusion criteria (14 listed)
- Failure to meet standard MRI inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. Pregnancy, determined by pregnancy tests on females.
- Medical contraindications for Transcranial Magnetic Stimulation (TMS):
- Acute suicidality or other psychiatric crises requiring treatment escalation
- Changes made to treatment regimen within 4 weeks of baseline assessment
- Reading level <6th grade
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 |
|---|---|---|
| Habit Override PracticeComputerized "brain training" to provide practice in overriding avoidance habits. | Behavioural | cTBS, iTBS |
| Transcranial Magnetic StimulationNon-invasive method for temporary, focal stimulation of brain areas. | Other | cTBS, iTBS |
Primary outcome
functional Magnetic Resonance Imaging (fMRI)
Time frame: 10-60min
Brain activation in target region
8 secondary outcomes
Effort to resist compulsive behaviors in response to laboratory triggers
Time frame: 90min-1 week
Duration of compulsive behaviors in response to laboratory triggers
Time frame: 90min-1 week
Intensity of urges to perform compulsive behaviors in response to laboratory triggers
Time frame: 90min-1 week
Two-step task
Time frame: 90min-1 week
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 1 week
WHO Disability Assessment Scale 2.0
Time frame: 1 week
Obsessive Compulsive Inventory-Revised (OCI-R)
Time frame: 1 week
Habit override task
Time frame: 1 week
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 16 Aug 2022.
- Derived from this study: PubMed 35230864Brown VM, Gillan CM, Renard M, Kaskie R, Degutis M, Wears A, Siegle GJ, Ferrarelli F, Ahmari SE, Price RB. A double-blind study assessing the impact of orbitofrontal theta burst stimulation on goal-directed behavior. J Psychopathol Clin Sci. 2022 Apr;131(3):287-300. doi: 10.1037/abn0000733. Epub 2022 Feb 7.
- Individual participant dataSharing planned: Yes. We will comply with all National Institute of Mental Health (NIMH) guidelines regarding data sharing and make use of NIMH databases.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habit Override Practice and Transcranial Magnetic Stimulation in people with Compulsive Behavior and Obsessive-Compulsive Disorder, run by University of Pittsburgh 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 5 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 16 Aug 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. 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?
functional Magnetic Resonance Imaging (fMRI) (time frame: 10-60min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03265015, which also lists 1 linked publication.
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 16 Aug 2022.