Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001307
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Positron Emission Tomography to Measure Pain and Pain Control
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine how the brain processes pain signals and how the different parts of the brain work with each other in response to painful stimuli A better understanding of how people experience pain may be helpful in developing more effective treatments
Healthy normal volunteers patients requiring third molar wisdom tooth extraction and patients with persistent pain due to disease injury or other reason may be eligible for this study
Participants will receive one or more of the following sensory stimuli which may cause brief discomfort or pain
HeatCold - applied by an electronically controlled device that touches the skin or by temperature-controlled water baths or by a thermally controlled brass cylinder the subject grasps
Capsaicin active ingredient in hot chili peppers - injected in a small volume of fluid under the skin or into a muscle
Mechanical stimulation - brushings or vibrations that do not normally cause pain
Ischemic stimulation - inflation of a blood pressure cuff on the arm or leg for up to 30 minutes
These stimuli will be applied both before and during positron emission tomography PET scanning This test shows which parts of the brain are active and which are not and is important for studying how different parts of the brain work together to feel and react to specific sensations For this procedure the subject lies on a table in the PET scanner while a series of scans are taken during different sensory conditions At the beginning of each scan radioactive water is injected into an arm vein through a catheter a thin plastic tube A special camera records the arrival and disappearance of the radiation in various brain areas creating a picture of the brains activity in various regions Oral surgery patients may have PET scans both before and after their wisdom tooth extraction Alfentanil a commonly used narcotic pain reliever will also be given during the PET procedure to determine how the brain responds to sensory stimuli while under the effects of a pain killer
Participants will also have a magnetic resonance imaging MRI scan of the brain to help interpret the PET results MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues During the scan the subject lies on a table in a cylindrical machine the scanner He or she can speak with a staff member via an intercom system
Some sensory studies may require placing an arterial andor intravenous line Following injection of a local anesthetic a catheter is placed in an artery in the arm At regular intervals during various sensory stimuli small blood samples are drawn from the artery to measure blood gases and other substances Samples may also be drawn from a catheter placed in a vein
Subjects may also have ultrasound monitoring to evaluate blood flow in the arteries veins and brain A gel is spread over the skin above the blood vessel and a hand-foot-and-mouth device is placed on the gel The device emits high-frequency sound waves to produce a picture of the speed of blood flow in the artery and the diameter of the vessel
Healthy normal volunteers patients requiring third molar wisdom tooth extraction and patients with persistent pain due to disease injury or other reason may be eligible for this study
Participants will receive one or more of the following sensory stimuli which may cause brief discomfort or pain
HeatCold - applied by an electronically controlled device that touches the skin or by temperature-controlled water baths or by a thermally controlled brass cylinder the subject grasps
Capsaicin active ingredient in hot chili peppers - injected in a small volume of fluid under the skin or into a muscle
Mechanical stimulation - brushings or vibrations that do not normally cause pain
Ischemic stimulation - inflation of a blood pressure cuff on the arm or leg for up to 30 minutes
These stimuli will be applied both before and during positron emission tomography PET scanning This test shows which parts of the brain are active and which are not and is important for studying how different parts of the brain work together to feel and react to specific sensations For this procedure the subject lies on a table in the PET scanner while a series of scans are taken during different sensory conditions At the beginning of each scan radioactive water is injected into an arm vein through a catheter a thin plastic tube A special camera records the arrival and disappearance of the radiation in various brain areas creating a picture of the brains activity in various regions Oral surgery patients may have PET scans both before and after their wisdom tooth extraction Alfentanil a commonly used narcotic pain reliever will also be given during the PET procedure to determine how the brain responds to sensory stimuli while under the effects of a pain killer
Participants will also have a magnetic resonance imaging MRI scan of the brain to help interpret the PET results MRI uses a magnetic field and radio waves to show structural and chemical changes in tissues During the scan the subject lies on a table in a cylindrical machine the scanner He or she can speak with a staff member via an intercom system
Some sensory studies may require placing an arterial andor intravenous line Following injection of a local anesthetic a catheter is placed in an artery in the arm At regular intervals during various sensory stimuli small blood samples are drawn from the artery to measure blood gases and other substances Samples may also be drawn from a catheter placed in a vein
Subjects may also have ultrasound monitoring to evaluate blood flow in the arteries veins and brain A gel is spread over the skin above the blood vessel and a hand-foot-and-mouth device is placed on the gel The device emits high-frequency sound waves to produce a picture of the speed of blood flow in the artery and the diameter of the vessel
Detailed Description:
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 ie rating 49 degrees C as a 08 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 92-D-0243 | None | None | None |