Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)
Recruiting
Observational Study
Failed Back Surgery Syndrome (FBSS)
Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine
Neurophysiological Sensitivity to Spinal Cord Stimulation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 20 (estimated)
- Sponsor
- Brai²n · Other
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About This Trial
This pilot study investigates the effects of reducing pain medication including opioids and anticonvulsants, on spinal cord sensitivity during closed-loop spinal cord stimulation (SCS). Patients with Persistent Spinal Pain Syndrome Type 2 (FBSS/FNSS) will undergo a standard 21-day SCS trial with the Evoke closed-loop system, followed by permanent implantation if successful. Neurophysiological resp…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Candidate for SCS and scheduled for trial with Evoke system.
* Diagnosis of FBSS or FNSS (PSPS-T2).
* Current use of ≥1 qualifying pain medication at or above minimum daily dose:
* Gabapentin ≥150 mg
* Pregabalin ≥75 mg
* Morphine ≥40 mg
* Hydromorphone ≥10 mg
* Oxycodone ≥20 …
Contacts