Completed

Somatosensory Studies of Pain and Pain Control Measured With Oxygen-15 Water Positron Emission Tomography and Functional MRI in Normals and Patients With Neuropathic or Chronic Pain Conditions

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What is being collected

Drug Data

+ drug Data

Drug
Who is being recruted

Autonomic Nervous System Diseases+14

+ Nervous System Diseases

+ Neurologic Manifestations

See all eligibility criteria
How is the trial designed

Observational
Study Start: August 1992
See protocol details

Summary

Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1992

Actual date on which the first participant was enrolled.

Regional cerebral blood flow (rCBF) will be measured while normal subjects, patients with post-operative pain, and patients with neuropathic abnormalities of pain sensation are exposed to a battery of somatosensory stimuli that activate known pathways subserving touch, temperature and pain sensations. We have performed a series of studies on the genetics of pain, which assessed sensitivity (via subjective ratings) to a series of warm and painfully hot thermal pulses. Subjects ranged from insensitive (i.e. rating 49 degrees C as a 0.8 versus a 10 on a 10 point scale), yet mathematically we could define an inflection point at the transition from warm to hot in nearly everyone, thus they most subjects encode the nociceptive input and they all alter their ratings at the threshold for C-fiber afferent firing (45 degrees C). We need to understand how the brain responds using objective blood flow endpoints. Our previous studies disclosed distinct pain-intensity driven network of regions activated by hot thermal stimuli and we will use repetitive scans to determine the degree of activation of this network in the sensitive and insensitive subjects. We have also developed a new treatment for cancer and arthritic pain that involves deletion of the primary afferent C-fibers. We are in the midst of getting approval from the FDA for use of this in patients with cancer pain. Assuming we obtain approval, we may then have the potential to scan some of the appropriate patients before and after treatment to determine the impact of the treatment and to explore alterations in the pain network in subjects with and without C-fiber afferents using experimental stimuli. We also expect to eventually treat patients with peripheral neuropathies and other chronic pain conditions that cause spontaneous pain, hyperalgesia, and allodynia (pain sensation to a normally non-noxious stimulus) and they will be examined with and without applied experimental stimuli before and after treatment.

NCT00001307
Principal SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

273 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autonomic Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesPerceptual DisordersSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral ManifestationsSomatosensory DisordersComplex Regional Pain SyndromesAgnosiaHyperalgesiaPainPeripheral Nervous System DiseasesReflex Sympathetic DystrophyChronic Pain

Criteria

INCLUSION CRITERIA Healthy Normal Volunteers between the ages of 18 and 80 years Certain Chronic Pain Patients EXCLUSION CRITERIA Structural or Functional Brain Defects Metallic Surgical Implants Chronic Drug Treatments

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, United StatesOpen National Institute of Dental And Craniofacial Research (NIDCR) in Google Maps
CompletedOne Study Center