BurstDR Spinal Cord Stimulation Versus Sham in Established Responders
18. august 2026 oppdatert av: Pedram Tabatabaei Shafiei, Umeå University
Passive Recharge Burst Spinal Cord Stimulation vs Sham Stimulation in Established Responders: A Randomized, Double-Blind Crossover Clinical Trial
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
BurstDR spinal cord stimulation is a paresthesia-free neuromodulation therapy used for the treatment of chronic pain. Although clinical studies have demonstrated beneficial outcomes with BurstDR therapy, the specific contribution of ongoing stimulation, separate from contextual effects, expectation, natural symptom variation, and other nonspecific influences, remains incompletely defined.
This study uses a randomized, double-blind, two-period crossover design in patients who are already implanted with a spinal cord stimulation system and have an established clinical response to BurstDR therapy. Studying established responders avoids potential confounding associated with implantation, postoperative recovery, and initial programming and optimization, and allows the effect of ongoing stimulation to be evaluated under controlled conditions.
Before the randomized treatment periods, each participant will complete a baseline observation under their established active BurstDR settings, followed by a washout period with stimulation switched off. Participants will then undergo two randomized treatment periods: one with active BurstDR stimulation and one with sham stimulation, separated by a second washout period. The order of the two conditions will be randomly assigned, allowing each participant to serve as their own control and thereby reducing the influence of between-patient variability.
During the active condition, stimulation will be delivered using the participant's established clinically effective BurstDR program. During the sham condition, stimulation output will be switched off while study procedures, participant contacts, and data collection will otherwise remain comparable between conditions.
Because BurstDR stimulation is intended to be paresthesia-free, it provides an opportunity for blinded comparison with sham stimulation. Before the randomized treatment phase, a standardized perceptibility assessment will be performed to confirm that participants cannot reliably perceive whether stimulation is active. Device access and information that could reveal treatment allocation will be restricted, and treatment programming will be performed by designated study personnel who are not involved in outcome assessment or the primary analysis.
The crossover and washout design is intended to minimize residual stimulation effects and provide a controlled assessment of the specific contribution of ongoing BurstDR therapy in patients who have previously demonstrated clinical benefit from this treatment.
Studietype
Intervensjonell
Registrering (Antatt)
28
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Pedram Tabatabaei, MD, PhD
- Telefonnummer: +46-70-7603239
- E-post: pedram.tabatabaei@umu.se
Studiesteder
-
-
-
Umeå, Sverige, 90185
- University Hospital of Northern Sweden
-
Ta kontakt med:
- Pedram Tabatabaei, MD, PhD
- Telefonnummer: +46707603239
- E-post: pedram.tabatabaei@umu.se
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria
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.
Exclusion Criteria
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
Andre navn:
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.
|
|
Eksperimentell: 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.
|
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.
Andre navn:
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham
Tidsramme: 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.
|
During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Within-Participant Difference in End-of-Period Treatment Satisfaction Score Between Active BurstDR and Sham
Tidsramme: At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
|
Overall treatment satisfaction is assessed on a 0-10 scale at the end of each 7-day randomized treatment period.
Scores obtained following active BurstDR and sham stimulation are compared within each participant.
|
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
Tidsramme: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
|
Patient Global Impression of Change for sleep quality is assessed once daily using a 5-point scale during each randomized treatment period.
For each participant and treatment period, the median of all available daily sleep ratings is calculated and compared between active BurstDR and sham stimulation.
|
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
Tidsramme: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
|
Patient Global Impression of Change for mood is assessed once daily using a 5-point scale during each randomized treatment period.
For each participant and treatment period, the median of all available daily mood ratings is calculated and compared between active BurstDR and sham stimulation.
|
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
Tidsramme: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
|
Patient Global Impression of Change for daily activity is assessed once daily using a 5-point scale during each randomized treatment period.
For each participant and treatment period, the median of all available daily ratings is calculated and compared between active BurstDR and sham stimulation.
|
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
Tidsramme: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
|
Patient Global Impression of Change for social activity is assessed once daily using a 5-point scale during each randomized treatment period.
For each participant and treatment period, the median of all available daily ratings is calculated and compared between active BurstDR and sham stimulation.
|
Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
|
|
Perceptibility of Active BurstDR Stimulation Before Randomized Treatment
Tidsramme: At the baseline/programming visit, before the 1-day baseline diary and before Washout 1
|
A standardized perceptibility assessment using brief randomized stimulation ON/OFF intervals is performed before the first randomized treatment period to verify that the participant cannot reliably perceive active BurstDR stimulation.
|
At the baseline/programming visit, before the 1-day baseline diary and before Washout 1
|
|
Number of Participants With Adverse Events, Serious Adverse Events, and Stimulation-Related Complaints
Tidsramme: From baseline through Day 22 after baseline (completion of the second randomized treatment period)
|
Adverse events, serious adverse events, and stimulation- or device-related complaints are recorded during study participation.
Events will be summarized descriptively and, where feasible, according to whether they occurred during active BurstDR stimulation, sham stimulation, or washout.
|
From baseline through Day 22 after baseline (completion of the second randomized treatment period)
|
|
Participant-Reported Perception of Stimulation During Each Randomized Treatment Period
Tidsramme: At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
|
At the end of each randomized treatment period, participants are asked whether they felt stimulation or paresthesia at any time during that treatment period.
Responses are summarized by treatment condition to assess the integrity of masking.
|
At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Pedram Tabatabaei, MD, PhD, Umeå University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
30. september 2026
Primær fullføring (Antatt)
31. desember 2026
Studiet fullført (Antatt)
31. mars 2027
Datoer for studieregistrering
Først innsendt
13. august 2026
Først innsendt som oppfylte QC-kriteriene
18. august 2026
Først lagt ut (Faktiske)
21. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Dnr 2026-03871-01
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data underlying the primary and secondary results of the study will be available to qualified researchers upon reasonable request following publication of the main study results, subject to applicable data protection legislation, institutional governance, participant confidentiality requirements, and approval of the proposed research purpose.
IPD-delingstidsramme
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.
Tilgangskriterier for IPD-deling
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.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .