BurstDR Spinal Cord Stimulation Versus Sham in Established Responders

NCT07779733 · tracked via the Priya Life Science Sweden tracker

Sponsor

Umeå University

Phase

Not applicable

Started

2026-09-30

Last updated

2026-08-21

Condition(s) studied

Chronic Pain

Investigational drug(s) / intervention(s)

BurstDR Spinal Cord StimulationSham Spinal Cord Stimulation

BurstDR Spinal Cord Stimulation: Active BurstDR spinal cord stimulation is delivered for 7 consecutive days using each participant's established clinically effective stimulation settings. Electrode configuration, pulse pattern, pulse width, frequency structure, and amplitude are maintained according to the participant's established therapeutic program, with any adjustment required to maintain imperceptible stimulation completed before the randomized treatment periods.

Sham Spinal Cord Stimulation: During sham stimulation, the implanted spinal cord stimulation system remains in place but stimulation output is switched off for 7 consecutive days. The participant-facing programmer is locked and visible device information that could reveal treatment allocation is masked. Study contacts, diary assessments, and follow-up procedures are otherwise equivalent to those during active stimulation.

Study summary

This study aims to determine whether ongoing BurstDR spinal cord stimulation (SCS) provides pain relief beyond sham stimulation in patients with chronic pain who are established responders to BurstDR therapy.

Participants already implanted with an SCS system and experiencing stable clinical benefit from BurstDR will undergo both active stimulation and sham stimulation in a randomized, double-blind crossover design. Each participant will therefore serve as their own control.

The primary question is whether pain intensity is lower during active BurstDR stimulation compared with sham stimulation. The study will also evaluate treatment satisfaction, patient-reported changes in sleep, mood, daily activity and social activity, the effectiveness of blinding, and short-term safety and tolerability.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria Participants must meet all of the following: 1. Be 18 years of age or older. 2. Have an implanted spinal cord stimulation system that can deliver BurstDR stimulation. 3. Have had a good and stable response to BurstDR therapy, defined as at least a 50% reduction in pain compared with pain before implantation or before starting BurstDR therapy, maintained for at least 3 months on stable stimulation settings. 4. Have had no major change in pain medication for at least 4 weeks before entering the study. 5. Be able to understand the study information and provide written informed consent. 6. Be willing and able to complete the study's electronic diaries and follow the study procedures. Exclusion Criteria Participants cannot take part if any of the following apply: 1. An active infection, wound problem, or other significant problem at the site of the implanted spinal cord stimulation system. 2. A known or suspected problem with the implanted stimulation system that could affect treatment delivery or safety. 3. A serious uncontrolled mental health condition, significant problems with memory or thinking, or another condition that could make it difficult to understand the study, provide informed consent, follow the study procedures, or provide reliable study information. 4. Planned surgery, planned changes to spinal cord stimulation programming outside the study, or an expected change in pain medication during the study period. 5. Pregnancy or breastfeeding. 6. Inability to use the electronic diary system when no practical alternative or assistance can be provided. 7. Any other medical or personal condition that, in the investigator's judgment, would make participation unsafe or inappropriate.

Primary outcome measure(s)

Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham — During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
Pain intensity is recorded twice daily, morning and evening, using an 11-point Numeric Rating Scale (NRS; 0=no pain to 10=worst pain) for each predefined pain area during each randomized treatment period. All available NRS ratings within each participant and treatment period are pooled, and the period-level median is calculated. The primary outcome is the within-participant paired difference between sham and active BurstDR stimulation (Sham minus Active), with positive values favoring active BurstDR. Baseline-day NRS data are not included in the primary endpoint.

Trial sites (1)

Facility	City	Region	Status
University Hospital of Northern Sweden	Umeå	Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07779733 on ClinicalTrials.gov ↗ ← All trials in Sweden