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NCT07502612: ECAP-MED Pilot

Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)

Recruiting now Last updated 31 March 2026
What this trial tests

trial testing Spinal Cord Stimulation with Evoke Closed-Loop System in Failed Back Surgery Syndrome (FBSS) in 20 participants. Currently enrolling.

Timeline
8 June 2022
Primary endpoint
28 July 2026
28 August 2026

Quick facts

Lead sponsorBrai²n
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment20
Start date8 June 2022
Primary completion28 July 2026
Estimated completion28 August 2026
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Brai²n

Who can join

18 and older, any sex, with Failed Back Surgery Syndrome (FBSS) or Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 responses (activation plots, conduction velocity, chronaxie, rheobase) and patient-reported outcomes (VAS, activity, sleep, medication intake) will be collected during the trial and up to 6 months after implantation. The goal is to evaluate the relationship between medication tapering and spinal cord sensitivity

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Spinal Cord Stimulation with Evoke Closed-Loop System

Trials testing the same drug.

Other Brai²n trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07502612.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing