- ICH GCP
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- Klinische Studie NCT02751216
EEG Mapping During High Frequency/High Density Spinal Cord Stimulation in Patients With Failed Back Surgery Syndrome (EEGInspiration)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Vlaams Brabant
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Brussels, Vlaams Brabant, Belgien, 1090
- UZ Brussel
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Rückenmarkstimulation
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Functional connectivity
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Functioning of the descending inhibitory pathway
Zeitfenster: The change between baseline and 1 month after definitive implantation of the neurostimulator
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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
Zeitfenster: 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).
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Maarten Moens, Prof. dr., Universitair Ziekenhuis Brussel
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- EEGInspiration1
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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