fMRI and DTI of Cerebellar Responses to Pain in the Human Trigeminal System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eric Alan Moulton, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01738126
First received: November 28, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition
Cerebellum and Pain in Healthy Volunteers.

Study Type: Observational
Study Design: Observational Model: Cohort

Resource links provided by NLM:


Further study details as provided by Mclean Hospital:

Primary Outcome Measures:
  • Whole brain functional magnetic resonance imaging (fMRI) data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Subjective pain ratings elicited by experimental stimuli.

  • Whole-brain diffusion tensor imaging (DTI) data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    DTI data measures the integrity of white matter tracts in the brain, based on principles of water diffusion.


Estimated Enrollment: 80
Study Start Date: May 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy human volunteers

Criteria

Inclusion Criteria:

  • Right-handed subjects
  • Good physical health
  • No history of claustrophobia
  • English speaking and reading ability sufficient to comprehend consent without assistance

Exclusion Criteria:

  • 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
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Eric Alan Moulton, Assistant Professor, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01738126     History of Changes
Other Study ID Numbers: NIH-K01DA025289
Study First Received: November 28, 2012
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mclean Hospital:
trigeminal system
cerebellum
fMRI
DTI
pain
heat
noxious
aversion
unpleasantness
anger
aversive stimulus
motor
human
image analysis
perception
central nervous system
sensory
somatosensory cortex
white matter

ClinicalTrials.gov processed this record on July 29, 2014