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

NCT07211308 | Not Yet Recruiting DMC

• 1 other identifier: ENDLESS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall pain intensity

  The primary effectiveness outcome measure is pain intensity measured with the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (maximal pain) in electronic format. Two scales will be presented for low back/neck pain and for leg/arm pain. Ecological momentary Assessment (EMA) will be used to collect pain intensity scores for VAS, whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias.

  The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

Secondary Outcomes (20)

• Pain intensity for the lower back and leg pain or neck and arm pain component

  The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

• Medication use

  The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

• Negative affect

  The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

• Functional disability

  The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

• Health related quality of life

  The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

Interventions

Spinal Cord Stimulation DEVICE

Differential target multiplexed stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (2)

UZ Brussel

Brussels, Belgium

Location

Vitaz

Sint-Niklaas, Belgium

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Maarten TA Moens, MD, PhD

CONTACT

003224775514; maarten.moens@uzbrussel.be

Lisa Goudman, PT, MSc, PhD

CONTACT

003224775514; lisa.goudman@gmail.com

Study Design

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

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: October 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 7, 2025

Record last verified: 2025-09

Locations

BE (2)