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BurstDR Spinal Cord Stimulation Versus Sham in Established Responders

NCT07779733 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-08-21

No results posted yet for this 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.

Conditions

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Principal Investigators

  • Pedram Tabatabaei, MD, PhD · Umeå University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07779733 on ClinicalTrials.gov