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BurstDR Spinal Cord Stimulation Versus Sham in Established Responders

18. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

28

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Schweden
      • Umeå, Schweden, 90185
        • University Hospital of Northern Sweden
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Andere Namen:
  • Passive Recharge Burst Spinal Cord Stimulation
Gerät: 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.
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.
Gerät: 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.
Andere Namen:
  • Passive Recharge Burst Spinal Cord Stimulation
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Within-Participant Difference in End-of-Period Treatment Satisfaction Score Between Active BurstDR and Sham
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Umeå University

Ermittler

  • Hauptermittler: Pedram Tabatabaei, MD, PhD, Umeå University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. September 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

31. März 2027

Studienanmeldedaten

Zuerst eingereicht

13. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. August 2026

Zuerst gepostet (Tatsächlich)

21. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Dnr 2026-03871-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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