Relief From Side Effects: Clinical Use of Electrodes With Direction (RESCUED)
6. januar 2019 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
6
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E3
- Rekruttering
- 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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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tremor Control
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of life based on participant's best real life setting
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. september 2018
Primær færdiggørelse (Forventet)
1. juli 2019
Studieafslutning (Forventet)
1. august 2019
Datoer for studieregistrering
Først indsendt
17. september 2018
Først indsendt, der opfyldte QC-kriterier
6. januar 2019
Først opslået (Faktiske)
8. januar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. januar 2019
Sidst verificeret
1. januar 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H17-00672
Plan for individuelle deltagerdata (IPD)
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