BurstDR Spinal Cord Stimulation Versus Sham in Established Responders

NCT07779733 | Not Yet Recruiting

• 1 other identifier: Dnr 2026-03871-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pain

Keywords

Spinal Cord Stimulation; Passive Recharge Burst Spinal Cord Stimulation; Burst Stimulation; Neuromodulation; Sham Stimulation; Paresthesia-Free Stimulation; Established Responders

Outcome Measures

Primary Outcomes (1)

• Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham

  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.

  During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)

Secondary Outcomes (8)

• Within-Participant Difference in End-of-Period Treatment Satisfaction Score Between Active BurstDR and Sham

  At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)

• Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Sleep Quality

  Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)

• Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Mood

  Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)

• Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Daily Activity

  Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)

• Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Social Activity

  Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)

Study Arms (2)

equence 1: Active BurstDR → Sham

EXPERIMENTAL

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.

Device: BurstDR Spinal Cord Stimulation; Device: Sham Spinal Cord Stimulation

Sequence 2: Sham → Active BurstDR

EXPERIMENTAL

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.

Device: BurstDR Spinal Cord Stimulation; Device: Sham Spinal Cord Stimulation

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.

Also known as: Passive Recharge Burst Spinal Cord Stimulation

Sequence 2: Sham → Active BurstDR; equence 1: Active BurstDR → Sham

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.

Sequence 2: Sham → Active BurstDR; equence 1: Active BurstDR → Sham

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following:
• Be 18 years of age or older.
• Have an implanted spinal cord stimulation system that can deliver BurstDR stimulation.
• 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.
• Have had no major change in pain medication for at least 4 weeks before entering the study.
• Be able to understand the study information and provide written informed consent.
• Be willing and able to complete the study's electronic diaries and follow the study procedures.

You may not qualify if:

• Participants cannot take part if any of the following apply:
• An active infection, wound problem, or other significant problem at the site of the implanted spinal cord stimulation system.
• A known or suspected problem with the implanted stimulation system that could affect treatment delivery or safety.
• 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.
• Planned surgery, planned changes to spinal cord stimulation programming outside the study, or an expected change in pain medication during the study period.
• Pregnancy or breastfeeding.
• Inability to use the electronic diary system when no practical alternative or assistance can be provided.
• Any other medical or personal condition that, in the investigator's judgment, would make participation unsafe or inappropriate.

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

University Hospital of Northern Sweden

Umeå, 90185, Sweden

Location

Related Publications (5)

• De Ridder D, Plazier M, Kamerling N, Menovsky T, Vanneste S. Burst spinal cord stimulation for limb and back pain. World Neurosurg. 2013 Nov;80(5):642-649.e1. doi: 10.1016/j.wneu.2013.01.040. Epub 2013 Jan 12.

  PMID: 23321375 BACKGROUND

• Deer TR, Falowski SM, Moore GA, Hutcheson JK, Pena I, Candido K, Cornidez EG, Fraunberg VUZ, Blomme B, Capobianco RA. Passive Recharge Burst Spinal Cord Stimulation Provides Sustainable Improvements in Pain and Psychosocial Function: 2-year Results From the TRIUMPH Study. Spine (Phila Pa 1976). 2022 Apr 1;47(7):548-556. doi: 10.1097/BRS.0000000000004283.

  PMID: 34812195 BACKGROUND

• Deer T, Slavin KV, Amirdelfan K, North RB, Burton AW, Yearwood TL, Tavel E, Staats P, Falowski S, Pope J, Justiz R, Fabi AY, Taghva A, Paicius R, Houden T, Wilson D. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2018 Jan;21(1):56-66. doi: 10.1111/ner.12698. Epub 2017 Sep 29.

  PMID: 28961366 BACKGROUND

• Schu S, Slotty PJ, Bara G, von Knop M, Edgar D, Vesper J. A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. Neuromodulation. 2014 Jul;17(5):443-50. doi: 10.1111/ner.12197. Epub 2014 Jun 19.

  PMID: 24945621 BACKGROUND

• Tabatabaei P, Wanman J, Awad A, Eriksson M, Salomonsson J, Bredemo L, Sjoberg R, Hariz MI, Blomstedt P. Subperception dorsal root ganglion stimulation versus sham stimulation in established responders: a randomized, double-blind crossover clinical trial. Reg Anesth Pain Med. 2026 May 13:rapm-2026-107906. doi: 10.1136/rapm-2026-107906. Online ahead of print.

  PMID: 42128597 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pedram Tabatabaei, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedram Tabatabaei, MD, PhD

CONTACT

+46-70-7603239; pedram.tabatabaei@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data analysts will also remain masked to treatment allocation. Only the designated programmer or study nurse responsible for randomization-linked device programming will have access to the treatment allocation. This individual will have no role in outcome assessment or the primary analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: This is a randomized, double-blind, two-period crossover study. Participants are randomized 1:1 to one of two treatment sequences: active BurstDR spinal cord stimulation followed by sham stimulation, or sham stimulation followed by active BurstDR spinal cord stimulation. Each treatment period lasts 7 days and the two randomized treatment periods are separated by a 4-day washout period during which stimulation is switched off. Before the first randomized treatment period, participants complete a 1-day baseline observation under their established active BurstDR settings followed by an initial 4-day washout period. Each participant receives both study conditions and therefore serves as their own control.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning after publication of the main study results. Data will remain available for a period consistent with institutional data-retention policies and applicable legal requirements.
• Access Criteria: Access may be granted to qualified researchers with a scientifically sound proposal and an appropriate research purpose. Requests will be reviewed by the principal investigator and/or the responsible institution. Data will be shared only in de-identified form and subject to applicable data protection requirements, institutional approval, and, where required, a data-sharing agreement.

Locations

SE (1)