Adaptive Deep Brain Stimulation (DBS) based on neurophysiological biomarkers is equally effective as continuous DBS with less side-effects and energy consumption.
ID
Bron
Aandoening
Parkinson’s Disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
blinded Unified Parkinson’s Disease Rating Scale part III score
Achtergrond van het onderzoek
Rationale: Deep brain stimulations (DBS) is an established treatment for movement disorders like Parkinson’s Disease (PD), dystonia and Essential Tremor (ET). With DBS, small electrical pulses are applied to deep brain nuclei which lead to motor improvements in these disorders. Although DBS has been successfully applied for over 25 years there are still limitations in terms of effectiveness, side-effects and energy consumption. There is evidence that all these limitations might all be due to excessive electrical stimulation. The mechanism of the limited effectiveness and side-effects could be due to the fact that both pathological and physiological neural activity are disturbed with conventional, continuous DBS (cDBS). Very recent studies have found evidence that DBS might work better were it only to stimulate when necessary. This type of stimulation is called adaptive DBS (aDBS) and uses neurophysiological signals as indicator of symptom severity and trigger to stimulate.
Objective: Test whether aDBS is non-inferior to cDBS in terms of effectiveness and superior in terms of side-effects and energy consumption in patients with Parkinson’s disease.
Doel van het onderzoek
Adaptive Deep Brain Stimulation (DBS) based on neurophysiological biomarkers is equally effective as continuous DBS with less side-effects and energy consumption.
Onderzoeksopzet
Primary: after 15 minutes of stimulation
Secondary I: after 20 minutes of stimulation
Secondary II: after 15 minutes of stimulation
Secondary III: 15 minute interval
Onderzoeksproduct en/of interventie
Intervention:
- application of adaptive deep
brain stimulation
Control interventions:
- continous stimulation
- no stimulation
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
sound of mind
eligible for battery replacement surgery
ability to provide written informed consent
ability to undergo testing in the OFF medication state
physical condition that enables 90 minutes of testing
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
all contra-indications that apply to normal DBS surgery (eg pregnancy, life expectancy of less than one year)
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL5232 |
NTR-old | NTR5456 |
Ander register | NL54475.042.15 : ABR |