Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-02

Study Completion Date

2029-12-31

Brief Summary

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

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Detailed Description

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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

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Chronic Pain Neuropathic Pain Persistent Spinal Pain Syndrome Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject is deemed a suitable candidate for SCS trial and permanent implant and has been routinely scheduled to undergo an SCS trial phase with the Evoke SCS System.
* Subject has a minimum of pain intensity of 5/10 on the numeric rating scale (NRS) at baseline
* Subject is ≥ 18 years old.
* Subject is not pregnant or nursing.
* Subject is willing and capable of giving informed consent.

Exclusion Criteria

* Subject currently has an active implantable device including pacemakers, spinal cord stimulator or intrathecal drug delivery system.
* Subject is incapable of understanding or responding to the study questionnaires.
* Subject is incapable of understanding or operating the patient programmer handset.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No