Obsessive-Compulsive DisorderNCT04688554
Psychosocial, Behavioral, and Radiologic Changes Following Radiosurgery for Benign Neurologic Disease
An observational study of Obsessive-Compulsive Disorder and Pain, Intractable, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
A number of studies from the literature suggest important behavioral, psychosocial, or radiologic changes occur following significant neurologic events or interventions such as stroke, neurosurgery, medications, radiation, systemic therapy, or injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder, Pain, Intractable, Depression
- What is being tested?
- fMRI and DTI, Behavioral questionnaires and Disease-Specific Patient-Reported Outcomes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to 1 Feb 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: VUMC adult patients with neurologic disease or patients with neurologic interventions such as neurosurgical procedures or radiation therapy. Men and women of any ethnicity, race or socioeconomic status who meet inclusion criteria will be offered enrollment into the study. Patient will be greater than 18 years of age and meet inclusion and exclusion criteria. Patients eligible for this study will include patients with neurologic events, including but not limited to stroke, depression, infections, psychiatric disease. Intervention is not part of this study, however, patients receiving neurologic interventions, such as neurosurgical procedures or radiation therapy, would be eligible.
Who may be able to join
- Age ≥ 18 years old and willing and able to sign a written informed consent.
- Eligible for Brain MRI
- History of neurologic event or intervention OR future planned neurologic intervention
Who cannot join
- Contraindications to MRI of the brain
- Patient declining participation in study
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5671
About this study
Official title: Psychosocial, Behavioral, and Radiologic Changes Following Neurologic Events or Interventions: A Prospective, Non-Interventional, Observational Study
A number of studies from the literature suggest important behavioral, psychosocial, or radiologic changes occur following significant neurologic events or interventions such as stroke, neurosurgery, medications, radiation, systemic therapy, or injury. The purpose of this study is to describe these changes with advanced neurologic imaging and targeted neurologic and neuropsychiatric assessments. This is a non-interventional observational study of minimal risk to participants as there is no medical intervention. The results of this study will be used to inform patients, scientists, and society in the development of future treatments.
Read the detailed description
Functional magnetic resonance imaging (fMRI) and diffusion tensor tractography (DTI) have rapidly expanded since its emergence two decades ago. fMRI is well established as the single most powerful method for detecting changes in neural activity in vivo, albeit indirectly by detection of changes in blood oxygenation level dependent (BOLD) signals that reflect hemodynamic changes subsequent to neural activity. A conventional fMRI experiment involves the comparison of two or more brain states followed by statistical tests to identify which brain regions were involved in a particular task. The identification of patterns of highly correlated low-frequency MRI signals in the resting brain provides a powerful approach to delineate and describe neural circuits, and an unprecedented ability to assess the manner in which distributed regions work together to achieve specific functions. Since the first reports of temporal correlations in BOLD baseline signals, several distinct cortical long-range networks have been identified and characterized in the resting state, including a default mode network. Moreover, observations of altered resting state connectivity in several disorders and as a function of behavior or cognitive skills suggest these correlations reflect an important level of brain organization and may play a fundamental role in the execution and maintenance of various brain functions. DTI is also an exceedingly important imaging modality that has elucidated the neural connectivity inherent between various cortical and subcortical structures. DTI is routinely used and has enhanced our understanding of functional connections between various parts of the brain. Prior to interventions, DTI is commonly obtained, so that interventionists can avoid critical circuitry. There is suggestion that both fMRI and DTI imaging is influenced by organic or interventional variables, however this is understudied. The neuroscientists and clinicians would greatly value information that would expand our working knowledge of the basic neural substrates and functional neural changes that occur in patients organically or after interventions. A non-invasive, non-interventional, observational study is needed to show the changes that happen to patients organically or in standard of care settings. A greater working understanding of the neural connectivity and changes that happen in the brain is of great future benefit to patients, science, and society as well as future therapeutic development such as post-stroke care, rehabilitation, post-traumatic brain injury, or post-treatment care in the brain that has previously been influenced by intervention or disease.
- Conditions
- Obsessive-Compulsive Disorder, Pain, Intractable, Depression
- Being tested
- fMRI and DTI, Behavioral questionnaires, Disease-Specific Patient-Reported Outcomes, Behavioral tests
- Keywords
- Stereotactic Radiosurgery, Cingulotomy, Capsulotomy
- Medical subject headings
- Obsessive-Compulsive Disorder, Pain, Intractable, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI and DTIDiagnostic test
Neurologic imaging correlates
Behavioral questionnairesBehavioural
RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
Disease-Specific Patient-Reported OutcomesBehavioural
Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
Behavioral testsBehavioural
Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.
| Study group | Role | What they receive |
|---|---|---|
| Refractory Obsessive Compulsive Disorder | fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy Receives: Diagnostic Test: fMRI and DTI; Behavioral: Behavioral questionnaires; Behavioral: Disease-Specific Patient-Reported Outcomes; Behavioral: Behavioral tests | |
| Refractory Pain | fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy Receives: Diagnostic Test: fMRI and DTI; Behavioral: Behavioral questionnaires; Behavioral: Disease-Specific Patient-Reported Outcomes; Behavioral: Behavioral tests | |
| Refractory Tremor | fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy Receives: Diagnostic Test: fMRI and DTI; Behavioral: Behavioral questionnaires; Behavioral: Disease-Specific Patient-Reported Outcomes; Behavioral: Behavioral tests | |
| Refractory Depression | fMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy Receives: Diagnostic Test: fMRI and DTI; Behavioral: Behavioral questionnaires; Behavioral: Disease-Specific Patient-Reported Outcomes; Behavioral: Behavioral tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery.
Yale-Brown Obsessive Compulsive Scale questionnaire
Measured: Every 3 months for 1 year or through study completion
Describe changes in Depression disease burden after stereotactic radiosurgery.
Beck's Depression inventory
Measured: Every 3 months for 1 year or through study completion
Describe changes in Pain disease burden after stereotactic radiosurgery.
McGill Pain Scale
Measured: Every 3 months for 1 year or through study completion
Secondary outcomes (2)
Describe changes in cognition after stereotactic radiosurgery.
Montreal Cognitive Assessment
Measured: Every 3 months for 1 year or through study completion
Describe changes in radiologic parameters after stereotactic radiosurgery.
Brain MRI
Measured: Every 6 months for 1 year or through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start25 Aug 2020
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
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.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Anthony Cmelak, Vanderbilt University Medical Center
- Investigators
- Anthony J Cmelak, MD, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688554
- Sponsor's protocol ID
- 200209
- Status last verified
- Dec 2024
- First submitted
- 16 Sep 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Research data will be shared upon reasonable request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial, Behavioral, and Radiologic Changes Following Neurologic Events or Interventions: A Prospective, Non-Interventional, Observational Study
- ClinicalTrials.gov ID
- NCT04688554
- Acronym / sponsor ID
- 200209
- Conditions
- Obsessive-Compulsive Disorder, Pain, Intractable, Depression
- Keywords
- Stereotactic Radiosurgery, Cingulotomy, Capsulotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 30 Dec 2020 (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.
A number of studies from the literature suggest important behavioral, psychosocial, or radiologic changes occur following significant neurologic events or interventions such as stroke, neurosurgery, medications, radiation, systemic therapy, or injury. The purpose of this study is to describe these changes with advanced neurologic imaging and targeted neurologic and neuropsychiatric assessments. This is a non-interventional observational study of minimal risk to participants as there is no medical intervention. The results of this study will be used to inform patients, scientists, and society in the development of future treatments.
Detailed description
Functional magnetic resonance imaging (fMRI) and diffusion tensor tractography (DTI) have rapidly expanded since its emergence two decades ago. fMRI is well established as the single most powerful method for detecting changes in neural activity in vivo, albeit indirectly by detection of changes in blood oxygenation level dependent (BOLD) signals that reflect hemodynamic changes subsequent to neural activity. A conventional fMRI experiment involves the comparison of two or more brain states followed by statistical tests to identify which brain regions were involved in a particular task. The identification of patterns of highly correlated low-frequency MRI signals in the resting brain provides a powerful approach to delineate and describe neural circuits, and an unprecedented ability to assess the manner in which distributed regions work together to achieve specific functions. Since the first reports of temporal correlations in BOLD baseline signals, several distinct cortical long-range networks have been identified and characterized in the resting state, including a default mode network. Moreover, observations of altered resting state connectivity in several disorders and as a function of behavior or cognitive skills suggest these correlations reflect an important level of brain organization and may play a fundamental role in the execution and maintenance of various brain functions. DTI is also an exceedingly important imaging modality that has elucidated the neural connectivity inherent between various cortical and subcortical structures. DTI is routinely used and has enhanced our understanding of functional connections between various parts of the brain. Prior to interventions, DTI is commonly obtained, so that interventionists can avoid critical circuitry. There is suggestion that both fMRI and DTI imaging is influenced by organic or interventional variables, however this is understudied. The neuroscientists and clinicians would greatly value information that would expand our working knowledge of the basic neural substrates and functional neural changes that occur in patients organically or after interventions. A non-invasive, non-interventional, observational study is needed to show the changes that happen to patients organically or in standard of care settings. A greater working understanding of the neural connectivity and changes that happen in the brain is of great future benefit to patients, science, and society as well as future therapeutic development such as post-stroke care, rehabilitation, post-traumatic brain injury, or post-treatment care in the brain that has previously been influenced by intervention or disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Refractory Obsessive Compulsive Disorder | – | Diagnostic Test: fMRI and DTI, Behavioral: Behavioral questionnaires, Behavioral: Disease-Specific Patient-Reported Outcomes, Behavioral: Behavioral testsfMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical capsulotomy |
| Refractory Pain | – | Diagnostic Test: fMRI and DTI, Behavioral: Behavioral questionnaires, Behavioral: Disease-Specific Patient-Reported Outcomes, Behavioral: Behavioral testsfMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy |
| Refractory Tremor | – | Diagnostic Test: fMRI and DTI, Behavioral: Behavioral questionnaires, Behavioral: Disease-Specific Patient-Reported Outcomes, Behavioral: Behavioral testsfMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical thalamotomy |
| Refractory Depression | – | Diagnostic Test: fMRI and DTI, Behavioral: Behavioral questionnaires, Behavioral: Disease-Specific Patient-Reported Outcomes, Behavioral: Behavioral testsfMRI, DTI, behavioral, psychological, and disease-specific changes following radiosugical cingulotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- VUMC adult patients with neurologic disease or patients with neurologic interventions such as neurosurgical procedures or radiation therapy. Men and women of any ethnicity, race or socioeconomic status who meet inclusion criteria will be offered enrollment into the study. Patient will be greater than 18 years of age and meet inclusion and exclusion criteria. Patients eligible for this study will include patients with neurologic events, including but not limited to stroke, depression, infections, psychiatric disease. Intervention is not part of this study, however, patients receiving neurologic interventions, such as neurosurgical procedures or radiation therapy, would be eligible.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old and willing and able to sign a written informed consent.
- Eligible for Brain MRI
- History of neurologic event or intervention OR future planned neurologic intervention
Key exclusion criteria (2 listed)
- Contraindications to MRI of the brain
- Patient declining participation in study
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 |
|---|---|---|
| fMRI and DTINeurologic imaging correlates | Diagnostic test | Refractory Depression, Refractory Obsessive Compulsive Disorder, Refractory Pain, Refractory Tremor |
| Behavioral questionnairesRAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam | Behavioural | Refractory Depression, Refractory Obsessive Compulsive Disorder, Refractory Pain, Refractory Tremor |
| Disease-Specific Patient-Reported OutcomesY-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale) | Behavioural | Refractory Depression, Refractory Obsessive Compulsive Disorder, Refractory Pain, Refractory Tremor |
| Behavioral testsBehavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing. | Behavioural | Refractory Depression, Refractory Obsessive Compulsive Disorder, Refractory Pain, Refractory Tremor |
Primary outcome
Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery.
Time frame: Every 3 months for 1 year or through study completion
Yale-Brown Obsessive Compulsive Scale questionnaire
Describe changes in Depression disease burden after stereotactic radiosurgery.
Time frame: Every 3 months for 1 year or through study completion
Beck's Depression inventory
Describe changes in Pain disease burden after stereotactic radiosurgery.
Time frame: Every 3 months for 1 year or through study completion
McGill Pain Scale
2 secondary outcomes
Describe changes in cognition after stereotactic radiosurgery.
Time frame: Every 3 months for 1 year or through study completion
Describe changes in radiologic parameters after stereotactic radiosurgery.
Time frame: Every 6 months for 1 year or through study completion
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 6 Dec 2024.
- Individual participant dataSharing planned: Yes. Research data will be shared upon reasonable request to the principal investigator.
Related trials for Obsessive-Compulsive Disorder
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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.
Anthony J Cmelak, MD study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obsessive-Compulsive Disorder and Pain, Intractable, run by Vanderbilt University Medical Center 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 3 inclusion and 2 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 6 Dec 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. 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?
Describe changes in Obsessive Compulsive Disorder disease burden after stereotactic radiosurgery. (time frame: Every 3 months for 1 year or through study completion). 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 6 Dec 2024.