Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation (NAA)

January 9, 2025 updated by: Karel Hanssens

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Roeselare, Belgium, 8800
        • Recruiting
        • Az Delta
        • Contact:
        • Contact:
          • Karel Hanssens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subjects suffering from chronic pain and are eligible for SCS trial and permanent implant.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Baseline, 3-months, 6-months, 12-months post-implant
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.
Baseline, 3-months, 6-months and 12-months post-implant
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.
3-months, 6-months and 12-months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karel Hanssens

Investigators

  • Principal Investigator: Karel Hanssens, Az Delta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 51773
  • CME AZ Delta (Other Identifier: Studie 20130)
  • Belgium registration number (Other Identifier: B1172021000026)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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