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NCT00078364 · ClinicalTrials.gov registry record · Phase 2
Pain Pathways in the Brain
A Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00078364 is a Phase 2 study that has completed, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 30 participants.
The verdict
NCT00078364, a Phase 2 study, has completed, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will evaluate brain pathways involved in feeling pain and pain relief following administration of pain medication. Magnetic resonance imaging (MRI) will be used to measure brain activity at sites that become more active following oral surgery and then to see if the activity changes after pain medication is administered. MRI combines a powerful magnet with an advanced computer system and radio waves to produce detailed pictures of organs and tissues. During the scan, the subject lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member via an intercom system at all times during the procedure. Healthy dental patients recruited through the NIH Clinical Research Volunteer Program may enroll in this study. Participants will undergo the following tests and procedures in two clinic visits: Visit 1 - Sensitivity Testing Participants are tested for sensitivity to warm and hot temperatures. A probe is applied to the skin (usually the forearm) and heated to temperatures ranging from room temperature to that of a hot cup of coffee. Participants rate the temperature using a scale ranging from "no pain" to the "worst pain imaginable" and rate the unpleasantness of the heat using a similar scale. The probe is applied up to 30 times, using random heat intensities. Participants are also asked compare the heat intensity to varying levels of sounds and to rate the magnitude of different sensations they have experienced in the past, such as the brightness of the sun and the loudness of a jet plane. A blood sample of about 2 ounces is also collected at this visit for DNA analysis to look for genes related to pain. Visit 2 - Oral Surgery Under local anesthetic, participants undergo extraction of their lower right wisdom tooth. After surgery, the patient is moved to the MRI scanner for brain imaging over 1-2 hours while the local anesthetic wears off. Patients may request a postoperative pain drug (Toradol) during the procedu
Interventions
- PROCEDURE MRI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-02 |
| Est. Completion | 2005-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00078364
The ClinicalTrials.gov registry entry for NCT00078364 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MRI is the first listed.
NCT00078364 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00078364 about?
NCT00078364 is a clinical study titled "Pain Pathways in the Brain". This study will evaluate brain pathways involved in feeling pain and pain relief following administration of pain medication. Magnetic resonance imaging (MRI) will be used to measure brain activity at sites that become more active following oral surgery and then to see if the activity changes after ...
What is the current status of trial NCT00078364?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2004-02. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00078364?
The interventions under investigation include: MRI (PROCEDURE).
Who is sponsoring clinical trial NCT00078364?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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