CompletedNot Applicable

A High Frequency Spinal Cord Stimulation PET-CT Scan Study

United Kingdom22 participantsStarted 2018-02-09

Plain-language summary

This study aims to investigate the clinical response to Spinal Cord Stimulation frequency parameters: 40Hz, 4000Hz and 10000Hz and explore the brain imaging changes using PET-CT scans. The response to these stimulator settings on health related quality of life will also be measured using validated questionnaires.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with intractable lumbar neuropathic pain who are due to receive Percutaneous Spinal Cord Stimulation as part of their standard treatment per NICE HTA guidance 159 at Barts Health NHS Hospitals. * Patients between 18 and 75 years of age. * Patients who have given their written informed consent. * Female patients of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test. * Patients must be able to communicate in English in order to complete validated questionnaires written in English only. Exclusion Criteria: * Patients with diabetes or any underlying neurological condition. * Patients known to have a condition that in the investigator's judgement precludes participation in the study. * Patients who have received an investigational drug or have used an investigational device in the 30 days preceding study entry. * Patients unable to comply with the study assessments and to complete the questionnaires.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The change in patient reported back pain levels (Numerical Rating Score)

Timeframe: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover

Trial details

NCT IDNCT03716557

SponsorBarts & The London NHS Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-31

View on ClinicalTrials.gov More Neuropathic Pain trials