Neuronal Activation Accuracy in Closed-loop Spinal Cord Stimulation

NCT06775535 | Recruiting

• 3 other identifiers: 51773CME AZ DeltaBelgium registration number
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with change in stimulation sensation

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

  6-months

Secondary Outcomes (3)

• NRS

  Baseline, 3-months, 6-months, 12-months post-implant

• Number of participants with reduced pain distribution

  Baseline, 3-months, 6-months and 12-months post-implant

• Paraesthesia mapping

  3-months, 6-months and 12-months post-implant

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karel Hanssens: lead

Study Sites (1)

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Karel Hanssens

  AZ Delta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karel Hanssens, Dr.

CONTACT

0032 51 23 69 12; ctc.pijn@azdelta.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: January 15, 2025
• Study Start: August 2, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 15, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)