NCT06775535

Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

Assessment of Neuronal Activation Accuracy and Stimulation Sensation in Patients with Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: Karel Hanssens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Observational, prospective, single-center to assess neuronal activation accuracy and stimulation sensation in patients with closed-loop spinal cord stimulation therapy.

Detailed description

The study follow patients with chronic pain who received an EvokeTM spinal cord stimulator. The main aim of this study is to evaluate what influence different settings on nerve activation have and how this affects patients\' sensation.

Conditions

• Chronic Pain
• Neuropathic Pain
• Persistent Spinal Pain Syndrome Type 2

Interventions

Type	Name	Description
DEVICE	ECAP-controlled, closed-loop SCS	Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Timeline

• Start date: 2023-08-02
• Primary completion: 2028-08-01
• Completion: 2029-12-01
• First posted: 2025-01-15
• Last updated: 2025-01-15

Locations

1 site across 1 country: Belgium