BurstDR Spinal Cord Stimulation Versus Sham in Established Responders
18 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
28
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Pedram Tabatabaei, MD, PhD
- Número de teléfono: +46-70-7603239
- Correo electrónico: pedram.tabatabaei@umu.se
Ubicaciones de estudio
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Umeå, Suecia, 90185
- University Hospital of Northern Sweden
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Contacto:
- Pedram Tabatabaei, MD, PhD
- Número de teléfono: +46707603239
- Correo electrónico: pedram.tabatabaei@umu.se
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
Otros nombres:
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.
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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.
|
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.
Otros nombres:
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Within-Participant Difference in Period-Level Median Numeric Rating Scale Pain Intensity Between Active BurstDR and Sham
Periodo de tiempo: During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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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.
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During each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Within-Participant Difference in End-of-Period Treatment Satisfaction Score Between Active BurstDR and Sham
Periodo de tiempo: At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
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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.
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At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
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Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Sleep Quality
Periodo de tiempo: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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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.
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Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Mood
Periodo de tiempo: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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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.
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Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Daily Activity
Periodo de tiempo: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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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.
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Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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Within-Participant Difference in Period-Level Median Patient Global Impression of Change Score for Social Activity
Periodo de tiempo: Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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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.
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Daily during each 7-day randomized treatment period (Days 5-11 and Days 16-22 after baseline)
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Perceptibility of Active BurstDR Stimulation Before Randomized Treatment
Periodo de tiempo: At the baseline/programming visit, before the 1-day baseline diary and before Washout 1
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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.
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At the baseline/programming visit, before the 1-day baseline diary and before Washout 1
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Number of Participants With Adverse Events, Serious Adverse Events, and Stimulation-Related Complaints
Periodo de tiempo: From baseline through Day 22 after baseline (completion of the second randomized treatment period)
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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.
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From baseline through Day 22 after baseline (completion of the second randomized treatment period)
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Participant-Reported Perception of Stimulation During Each Randomized Treatment Period
Periodo de tiempo: At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
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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.
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At the end of each 7-day randomized treatment period (Day 11 and Day 22 after baseline)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Pedram Tabatabaei, MD, PhD, Umeå University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
30 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
13 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2026
Publicado por primera vez (Actual)
21 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Dnr 2026-03871-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
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.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .