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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2029-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Spinal Cord Stimulation

Differential target multiplexed stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No