Cerebellum and Pain in Healthy Volunteers.NCT01738126
fMRI and DTI of Cerebellar Responses to Pain in the Human Trigeminal System
An observational study of Cerebellum and Pain in Healthy Volunteers., run by Mclean Hospital.
Trial summary
This K01 application is designed to prepare the applicant with the skills necessary to establish an independent research program on pain--related processing in the cerebellum. Although pain studies using functional imaging in humans consistently find cerebellar activation, the role of this structure during pain is… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebellum and Pain in Healthy Volunteers.
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2014
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy human volunteers
Who may be able to join
- Right-handed subjects
- Good physical health
- No history of claustrophobia
- English speaking and reading ability sufficient to comprehend consent without assistance
Who cannot join
- History of drug abuse or positive drug screen
- Magnetic Implants of any type (including dental bridges, crowns, retainers, orthodontic devices, etc)
- Weight > 285 pounds (weight limit of the fMRI table)
- Positive pregnancy screen
- Beck Depression Inventory II (BDI-II) score > 25 (moderate to severe depression)
- History of primary depression, anxiety disorders, or mood disorders
Show all 32Show fewer
- Prolonged use of antidepressants or anticonvulsants
- Evidence of local pathology; e.g. cancer affecting the face
- History of systemic disorders, e.g. multiple sclerosis
- History of chronic pain, e.g. back pain
- History of primary headache, e.g. migraine, tension-type headache
- Recent orofacial surgery or trauma
- History of central origin disorders, eg. stroke
- History of dermatological hypersensitivity in the facial area
- History of Eczema
- Significant medical history of seizure disorder, diabetes, cardiac disease including coronary artery disease, psychiatric problems; respiratory problems, liver disease, etc.
- Significant alcohol history (ingestion of 5 or more glasses (>40 oz) of alcohol per week)
- Claustrophobia
- Pregnancy
- Smokers
- Tattoos containing metallic ink on the neck, shoulders, upper arm and head (which could become heated up in the scanner, and potentially cause blistering or burning)
- Cardiac pacemakers
- Aneurysm clips and other vascular stents, filters, clips or other devices
- Prosthetic heart valves
- Other prostheses
- Neuro-stimulator devices
- Implanted infusion pumps
- Cochlear (ear) implants
- Ocular (eye) implants or known metal fragments in eyes
- Exposure to shrapnel or metal filings (sheet metal workers, welders, and others)
- Other metallic surgical hardware in vital areas
- Repeated monthly usage of the ovulation test kit fails to detect a luteinizing hormone surge (for females not on contraception only)
About this study
This K01 application is designed to prepare the applicant with the skills necessary to establish an independent research program on pain--related processing in the cerebellum. Although pain studies using functional imaging in humans consistently find cerebellar activation, the role of this structure during pain is unknown. In such studies, speculation regarding the cerebellum's function during a painful event is often influenced by its reputation as a coordinator of motor function, though animal studies have indicated that it may also modulate the neural encoding of noxious stimuli. The candidate has published work that indicates a functional dichotomy in the way the cerebellum responds to experimental pain in healthy subjects and neuropathic pain patients. This suggests that the cerebellum has been overlooked as a potential pain processing area, and research into this area could lend invaluable insight into the basic physiological circuitry involved with pain and its modulation.
The hypothesis of this project is that the cerebellum serves as an integrator of aversive stimuli and adaptive motor behavior, and may modulate the emotional and cognitive experience that distinguishes the perception of pain from the appreciation of innocuous sensory stimulation. A human trigeminal model of experimental pain will be used, as all the pain---related circuitry involved can be imaged along with the cerebellum at the same time. The specific aims are (1) to map cerebellar activations related to sensory coding of noxious stimuli and to correlate functional activity with anatomical connectivity using functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI); (2) to distinguish between pain and its anticipation based on cerebellar responses and connectivity; and (3) to determine whether physical pain and aversive images engage similar circuitry in the cerebellum. To accomplish these aims, the candidate will need to expand his background in fMRI of cortical and brainstem pain processing to encompass cerebellar physiology, become proficient in DTI analysis, and learn the white matter connectivity to and from the cerebellum. The research environment at McLean Hospital and the other affiliates of the Harvard Medical School system will provide the candidate with the resources to reach his aims within 4 years.
- Keywords
- cerebellum, fMRI, DTI, pain, heat, noxious, aversion, unpleasantness, anger, aversive stimulus, motor, human, image analysis, perception, central nervous system, sensory, somatosensory cortex, trigeminal system, white matter
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole brain functional magnetic resonance imaging (fMRI) data
fMRI data is used to indirectly measure neurophysiological responses in the brain using the blood oxygen level dependent (BOLD) signal.
Measured: 1 year
Pain ratings
Subjective pain ratings elicited by experimental stimuli.
Measured: 1 year
Whole-brain diffusion tensor imaging (DTI) data
DTI data measures the integrity of white matter tracts in the brain, based on principles of water diffusion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startMay 2009
- Primary completionJan 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellum and Pain in Healthy Volunteers.Studies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Alan Moulton, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738126
- Sponsor's protocol ID
- NIH-K01DA025289
- Status last verified
- Sep 2016
- First submitted
- 28 Nov 2012
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI and DTI of Cerebellar Responses to Pain in the Human Trigeminal System
- ClinicalTrials.gov ID
- NCT01738126
- Acronym / sponsor ID
- NIH-K01DA025289
- Keywords
- cerebellum, fMRI, DTI, pain, heat, noxious, aversion, unpleasantness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Nov 2012 (estimated)
- 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 K01 application is designed to prepare the applicant with the skills necessary to establish an independent research program on pain--related processing in the cerebellum. Although pain studies using functional imaging in humans consistently find cerebellar activation, the role of this structure during pain is unknown. In such studies, speculation regarding the cerebellum's function during a painful event is often influenced by its reputation as a coordinator of motor function, though animal studies have indicated that it may also modulate the neural encoding of noxious stimuli. The candidate has published work that indicates a functional dichotomy in the way the cerebellum responds to experimental pain in healthy subjects and neuropathic pain patients. This suggests that the cerebellum has been overlooked as a potential pain processing area, and research into this area could lend invaluable insight into the basic physiological circuitry involved with pain and its modulation.
The hypothesis of this project is that the cerebellum serves as an integrator of aversive stimuli and adaptive motor behavior, and may modulate the emotional and cognitive experience that distinguishes the perception of pain from the appreciation of innocuous sensory stimulation. A human trigeminal model of experimental pain will be used, as all the pain---related circuitry involved can be imaged along with the cerebellum at the same time. The specific aims are (1) to map cerebellar activations related to sensory coding of noxious stimuli and to correlate functional activity with anatomical connectivity using functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI); (2) to distinguish between pain and its anticipation based on cerebellar responses and connectivity; and (3) to determine whether physical pain and aversive images engage similar circuitry in the cerebellum. To accomplish these aims, the candidate will need to expand his background in fMRI of cortical and brainstem pain processing to encompass cerebellar physiology, become proficient in DTI analysis, and learn the white matter connectivity to and from the cerebellum. The research environment at McLean Hospital and the other affiliates of the Harvard Medical School system will provide the candidate with the resources to reach his aims within 4 years.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy human volunteers
Key inclusion criteria (4 listed)
- Right-handed subjects
- Good physical health
- No history of claustrophobia
- English speaking and reading ability sufficient to comprehend consent without assistance
Key exclusion criteria (32 listed)
- History of drug abuse or positive drug screen
- Magnetic Implants of any type (including dental bridges, crowns, retainers, orthodontic devices, etc)
- Weight > 285 pounds (weight limit of the fMRI table)
- Positive pregnancy screen
- Beck Depression Inventory II (BDI-II) score > 25 (moderate to severe depression)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whole brain functional magnetic resonance imaging (fMRI) data
Time frame: 1 year
fMRI data is used to indirectly measure neurophysiological responses in the brain using the blood oxygen level dependent (BOLD) signal.
Pain ratings
Time frame: 1 year
Subjective pain ratings elicited by experimental stimuli.
Whole-brain diffusion tensor imaging (DTI) data
Time frame: 1 year
DTI data measures the integrity of white matter tracts in the brain, based on principles of water diffusion.
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 15 Sep 2016.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebellum and Pain in Healthy Volunteers., run by Mclean Hospital.
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 4 inclusion and 32 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Whole brain functional magnetic resonance imaging (fMRI) data (time frame: 1 year). 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 15 Sep 2016.