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BurstDR Spinal Cord Stimulation Versus Sham in Established Responders

2026년 8월 18일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

28

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 스웨덴
      • Umeå, 스웨덴, 90185
        • University Hospital of Northern Sweden
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: 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.
다른 이름들:
  • Passive Recharge Burst Spinal Cord Stimulation
장치: 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.
실험적: 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.
장치: 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.
다른 이름들:
  • Passive Recharge Burst Spinal Cord Stimulation
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Within-Participant Difference in End-of-Period Treatment Satisfaction Score Between Active BurstDR and Sham
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Umeå University

수사관

  • 수석 연구원: Pedram Tabatabaei, MD, PhD, Umeå University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 30일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2027년 3월 31일

연구 등록 날짜

최초 제출

2026년 8월 13일

QC 기준을 충족하는 최초 제출

2026년 8월 18일

처음 게시됨 (실제)

2026년 8월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 18일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • Dnr 2026-03871-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다