BurstDR Spinal Cord Stimulation Versus Sham in Established Responders

Sponsor
Umeå University
Study ID
NCT07779733
Status
Not Yet Recruiting

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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • BurstDR Spinal Cord Stimulation — DEVICE
    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 — DEVICE
    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 Details

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.

Key Dates

First listed
Aug 21, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: equence 1: Active BurstDR → Sham
    Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings. After a second 4-day washout period with stimulation switched off, participants receive 7 days of sham stimulation, during which stimulation output remains switched off.
  • Experimental: Sequence 2: Sham → Active BurstDR
    Following a 1-day baseline observation under established active BurstDR settings, participants undergo a 4-day washout period with stimulation switched off. They then receive 7 days of sham stimulation, during which stimulation output remains switched off. After a second 4-day washout period with stimulation switched off, participants receive 7 days of active BurstDR spinal cord stimulation using their established clinically effective settings.

Primary Outcome Measure

Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham [ Time Frame: During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline) ]

Central Contacts

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