- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02751216
EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome (EEGInspiration)
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Vlaams Brabant
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Brussels, Vlaams Brabant, Belgie, 1090
- UZ Brussel
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: stimulace míchy
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Functional connectivity
Časové okno: The change between baseline and 1 month after definitive implantation of the neurostimulator
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Functioning of the descending inhibitory pathway
Časové okno: 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
|
The change between baseline and 1 month after definitive implantation of the neurostimulator
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Visual Analogue Scale (VAS) pain diary
Časové okno: 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).
|
|
Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Maarten Moens, Prof. dr., Universitair Ziekenhuis Brussel
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- EEGInspiration1
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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