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Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study | Clinical Trials | Clareo Health

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Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study

Open and Closed Loop Differential Target Multiplexed Spinal Cord Stimulation in Patients With Persistent Spinal Pain Syndrome Type II: a European Multicenter Cohort Study (ENDLESS)

NCT07211308•Universitair Ziekenhuis Brussel

View on ClinicalTrials.gov

Summary

Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•having chronic pain as a result of PSPS-T2 that exists for at least 6 months with at least moderate pain intensity (4 or higher measured on numeric rating scale (NRS) or 31mm or higher measured on visual analogue scale (VAS) for the dominant pain location.
•being offered treatment with DTM SCS
•being at least 18 years old

Exclusion Criteria

•Expected inability of patients to properly operate the SCS system
•History of coagulation disorders, lupus erythematosus, diabetic neuropathy
•Active malignancy
•Addiction to drugs and/or alcohol (more than 5 units /day)
•Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to complete questionnaires, as determined by the investigator
•Immune deficiency (e.g. HIV positive, immunosuppressiva)
•Life expectancy \< 1 year
•Local infection or other skin disorder at site of incision
•Pregnancy
•Other implanted active medical device

Locations (2)

UZ Brussel

Brussels, Belgium

Vitaz

Sint-Niklaas, Belgium

Key Dates

Start Date

October 1, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2029

Last Updated

October 7, 2025

Enrollment

200

ESTIMATED participants

Conditions

Persistent Spinal Pain Syndrome Type 2Failed Back Surgery SyndromeFailed Neck Surgery Syndrome

Interventions

Spinal Cord Stimulation

DEVICE

Contacts

Maarten TA Moens, MD, PhD

CONTACT

003224775514 maarten.moens@uzbrussel.be

Lisa Goudman, PT, MSc, PhD

CONTACT

003224775514 lisa.goudman@gmail.com

Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation

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Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), Lower SpineSpinal Cord Sensitivity to Neurostimulation+1 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study

Inclusion Criteria

Exclusion Criteria

Neurophysiological Effects of Medication Tapering During Treatment With Spinal Cord Stimulation

Comparing General Anesthesia, General Anesthesia With ESP Block or TLIP Block in Patients Undergoing Lumbar Surgeries

Subthreshold SCS or BMT

Burst Spinal Cord Stimulation (Burst-SCS) Study

Caregiver Burden and Correlation With Clinical Outcome in Spinal Cord Stimulation for Chronic Neuropathic Pain

NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators