- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02751216
EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome (EEGInspiration)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Based on the reimbursement rules in Belgium, a trial implantation of 4 weeks is necessary before implanting the definitive neurostimulator. The definitive neurostimulator will be implanted minimum 4 weeks after the trial implantation, when the patient reports more than 50% pain reduction and/or more than 50% reduction in pain medication.
Patients who are included in this study will have four extra study visits at the University Hospital Brussels. The first assessment will take place during the week prior to surgery, the second minimal one month after definitive implantation of the stimulator. The assessments consist of filling in the Pittsburgh Sleep Quality Index (PSQI) and the Pain Catastrophizing Scale (PCS) and recording brain activity before and during the pain protocol. Additionally, patients will wear an Actiwatch for measuring sleep patterns and fill in a VAS diary (back and leg pain separately), one month before the baseline assessment and one month before the second assessment.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Vlaams Brabant
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Brussels, Vlaams Brabant, Bélgica, 1090
- UZ Brussel
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Subject is at least 18 years old.
- Subject is able and willing to comply with the follow-up schedule and protocol
- Diagnosis of FBSS with predominant leg pain (VAS) > 5) and non-dominant back pain.
- Cognitive and language functioning enabling coherent communication between the examiner and the subject;
- Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy
- Stable neurologic function in the past 30 days
- In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device
- Subject is able to provide written informed consent
- Subject speaks Dutch or French.
Exclusion Criteria:
- Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial
- Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
- Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator, deep brain stimulator or intrathecal drug pump
- Subject is unable to operate the device or has no relative available.
- Subjects with indwelling devices that may pose an increased risk of infection
- Subjects currently has an active infection
- Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device
- Subject has participated in another clinical investigation within 30 days
- Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
- Subject has been diagnosed with cancer in the past 2 years
- Life expectancy < 6 months
- Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the Investigator's opinion, contraindicates lead placement
- Existing extreme fear for entering MRI
- General contraindication for MRI (pacemaker, etc…)
- Age male/female patient <18 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: estimulación de la médula espinal
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Functional connectivity
Periodo de tiempo: The change between baseline and 1 month after definitive implantation of the neurostimulator
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EEG recordings to measure functional connectivity in the brain
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The change between baseline and 1 month after definitive implantation of the neurostimulator
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Functioning of the descending inhibitory pathway
Periodo de tiempo: The change between baseline and 1 month after definitive implantation of the neurostimulator
|
Functioning of the descending pathway will be measured with the conditioned pain modulation paradigm by using electrical stimulation and cold water
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The change between baseline and 1 month after definitive implantation of the neurostimulator
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Visual Analogue Scale (VAS) pain diary
Periodo de tiempo: Three times every day (morning, afternoon and evening), starting 1 month before baseline measurements up to the second measurement 1 month after definitive implantation of the neurostimulator (at study completion).
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Three times every day (morning, afternoon and evening), starting 1 month before baseline measurements up to the second measurement 1 month after definitive implantation of the neurostimulator (at study completion).
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Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
Periodo de tiempo: The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation).
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This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality
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The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation).
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Pain Catastrophizing
Periodo de tiempo: The change between baseline and 1 month after definitive implantation of the neurostimulator
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Pain catastrophizing is assess be using the 'pain catastrophizing scale'.
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The change between baseline and 1 month after definitive implantation of the neurostimulator
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Subjective sleep quality
Periodo de tiempo: The change between baseline and 1 month after definitive implantation of the neurostimulator
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Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
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The change between baseline and 1 month after definitive implantation of the neurostimulator
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Maarten Moens, Prof. dr., Universitair Ziekenhuis Brussel
Publicaciones y enlaces útiles
Publicaciones Generales
- Moens M, Marien P, Brouns R, Poelaert J, De Smedt A, Buyl R, Droogmans S, Van Schuerbeek P, Sunaert S, Nuttin B. Spinal cord stimulation modulates cerebral neurobiology: a proton magnetic resonance spectroscopy study. Neuroradiology. 2013 Aug;55(8):1039-1047. doi: 10.1007/s00234-013-1200-7. Epub 2013 May 12.
- De Ridder D, Vanneste S. Burst and Tonic Spinal Cord Stimulation: Different and Common Brain Mechanisms. Neuromodulation. 2016 Jan;19(1):47-59. doi: 10.1111/ner.12368. Epub 2015 Nov 20.
- Goudman L, Brouns R, De Groote S, De Jaeger M, Huysmans E, Forget P, Moens M. Association Between Spinal Cord Stimulation and Top-Down Nociceptive Inhibition in People With Failed Back Surgery Syndrome: A Cohort Study. Phys Ther. 2019 Jul 1;99(7):915-923. doi: 10.1093/ptj/pzz051.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EEGInspiration1
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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