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NCT Number: NCT06775535

Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

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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Key information

Conditions

Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Persistent Spinal Pain Syndrome Type 2 Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECAP-controlled, closed-loop SCS

Device

Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Primary outcomes

  1. Number of participants with change in stimulation sensation

    Time frame: 6-months

    Stimulation sensation will be characterized by study participants as better, worse or same for 5 different closed-loop sensitivity settings.

Secondary outcomes

  1. NRS

    Time frame: Baseline, 3-months, 6-months, 12-months post-implant

    The numeric rating scale (NRS) is a pain screening tool. It is used to assess pain severity at that moment in time using a 0-10 scale. Zero meaning "no pain" and 10 meaning "the worst pain imaginable".

  2. Number of participants with reduced pain distribution

    Time frame: Baseline, 3-months, 6-months and 12-months post-implant

    Pain distribution will be assessed by showing a visual representation of the body that enables participants to indicate the locations of their pain.

  3. Paraesthesia mapping

    Time frame: 3-months, 6-months and 12-months post-implant

    Paraesthesia mapping will be assessed by showing a visual representation of the body that enables participants to indicate the locations where they feel paraesthesia.

Study contacts

Contact information is provided by the study sponsor or research team.

Karel Hanssens, Dr.

CONTACT

[email protected]

0032 51 23 69 12

Sponsors and collaborators

Lead sponsor

Karel Hanssens

Other

Registry information

Official study title

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

Acronym: NAA

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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