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A Feasibility Study to Investigate the Dynamic Brain Imaging in Patients Following SCS- DRG

NCT04508127 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2020-08-11

No results posted yet for this study

Summary

Targeted SCS is a standard and safe interventional pain procedure that is offered to patients with intractable neuropathic pain for their symptomatic relief. The known and reported complications include technical failure to perform the procedure, failure to gain symptomatic relief, trauma to nerve, and infection. These risks are very low in incidence and part of any interventional pain procedure in the spine.

PET-CT scan involves insertion of a cannula and administration of a dye (FDG) as a contrast in a patient who has been fasted for at least 6 hours. The procedure is lengthy and can take up to 2 to 3 hours. This includes a 30-60 minute resting time following the injection of contrast. The actual scan itself takes up to 30 minutes. There is a small chance of pain and redness at the injection site. Allergic reaction to the radio-contrast is rare and is usually mild. Patients with known allergy to FDG will not be recruited in the study. Some patients can feel claustrophobic at the time of the scan which can make them feel anxious. The PET-CT scan involves radiation with associated risks as detailed in the previous section. All these risks will be explained to the patients at the time of the informed consent.

Conditions

  • Neuropathic Pain

Interventions

DEVICE

Spinal cord stimulation

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2018-03-01
Completion
2018-03-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04508127 on ClinicalTrials.gov