Relief From Side Effects: Clinical Use of Electrodes With Direction (RESCUED)
6. Januar 2019 aktualisiert von: Christopher Honey, University of British Columbia
Relief From Side Effects: Clinical Use of Electrodes With Direction: a Prospective, Open Label, Clinical Trial for Thalamic Deep Brain Stimulation
Deep Brain Stimulation (DBS) uses electrical pulses sent through a lead (insulated wire) to help stop unwanted symptoms in a variety of brain diseases, including the tremor seen in patients with Essential Tremor (ET).
The current standard lead allows this stimulation to spread out uniformly in all directions.
As these diseases progress, however, the amount of electrical stimulation required to stop the symptom usually increases.
This may become problematic because the increased electrical stimulation required for advanced symptoms may spread outside the desired targeted area, and effect other parts of the brain and causing unwanted side effects.
A new type of DBS lead has been developed which can steer, or focus, the electrical stimulation in a given direction toward the desired target area and away from areas that would cause side effects.
We would like to quantify the benefit seen in patients who have been switched from the traditional lead to this new directional lead.
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Patients implanted with a DBS may experience unwanted side effects such as motor contractures, paresthesia, or dysarthria.
This occurs when the electrical field of the stimulation spreads out beyond the targeted area.
This is especially common in patients whose disease has progressed, and must use increasingly higher currents in order to regain control of their tremor.
Unfortunately, because the electrical field affects neurons in a symmetrical sphere around the DBS, it is often impossible to reach the additional desired neuronal elements without simultaneously affecting equidistant brain regions responsible for side effects.
For many of our advanced patients, this means choosing between a debilitating tremor or disabling side effects.The directional lead is a FDA and Health Canada approved DBS lead which features radially segmented electrodes which can selectively steer the electrical field in a predefined direction, orthogonal to the lead trajectory.
This will allow DBS clinicians to steer current towards desired structural areas, while avoiding locations, which produce negative side effects.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
6
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 4E3
- Rekrutierung
- The Vancouver General Hospital
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Kontakt:
- Christopher R Honey, MD, DPhil
- Telefonnummer: 604.875.5894
- E-Mail: chris.honey@telus.net
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Participants must have been implanted with the DBS
- Participants must have been diagnosed with Essential Tremor
- Participants must experience negative side effects from their DBS which limit control over their tremor
- Participants must be able to receive benefit from their stimulator, but at the cost of negative side effects
Exclusion Criteria:
- All individuals who meet criteria outlined in "inclusion criteria" may be eligible for this study
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Treatment
Patients who were previously implanted with a traditional DBS lead and have subsequently developed stimulation induced side effects will gain significantly more tremor control without side effects when re-implanted with a directional DBS lead.
We expect these patients' quality of life will improve.
These patients typically will have had significant tremor relief (greater than 75% reduction from preoperative tremor rating scale) without side effects at their one year post operative follow-up.
With the expected disease progression they will have had to increase their DBS stimulation to the degree that their DBS now causes side effects in order to block their tremor
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Individuals in this arm will have their stimulator settings programmed to the point in which they have maximum tremor control with no side effects.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Tremor Control
Zeitfenster: Assessed once all tests performed - 1 to 2 months post-operatively
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Maximum percentage change in tremor (as measured by the Tremor Rating Scale) without side-effects (comparing DBS "on" versus "off") in each patient using the standard lead compared to the directional lead.
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Assessed once all tests performed - 1 to 2 months post-operatively
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Quality of life based on participant's best real life setting
Zeitfenster: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
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Quality of life will be based on each participant's subjective opinion using the Short Form 36 (SF36) (a patient-reported survey focusing on health and quality of life) assessment form.
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Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
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Quality of life based on tremor management participant's best real life setting
Zeitfenster: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
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Quality of life will be based on each participant's subjective opinion using the Quality of Life in Essential Tremor Questionare.
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Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
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Quality of life based on voice handicap with participant's best real life setting
Zeitfenster: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
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Quality of life will be based on each participant's subjective opinion using the Vocal handicap Index scale.
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Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Toader E, Decre MM, Martens HC. Steering deep brain stimulation fields using a high resolution electrode array. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2061-4. doi: 10.1109/IEMBS.2010.5626472.
- Reinacher PC, Kruger MT, Coenen VA, Shah M, Roelz R, Jenkner C, Egger K. Determining the Orientation of Directional Deep Brain Stimulation Electrodes Using 3D Rotational Fluoroscopy. AJNR Am J Neuroradiol. 2017 Jun;38(6):1111-1116. doi: 10.3174/ajnr.A5153. Epub 2017 Apr 6.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
17. September 2018
Primärer Abschluss (Voraussichtlich)
1. Juli 2019
Studienabschluss (Voraussichtlich)
1. August 2019
Studienanmeldedaten
Zuerst eingereicht
17. September 2018
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
6. Januar 2019
Zuerst gepostet (Tatsächlich)
8. Januar 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Januar 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Januar 2019
Zuletzt verifiziert
1. Januar 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H17-00672
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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