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Smart brain stimulation in Parkinsonís disease


- candidate number22848
- NTR NumberNTR5456
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2015
- Secondary IDsABR NL54475.042.15
- Public TitleSmart brain stimulation in Parkinsonís disease
- Scientific TitleAdaptive Deep Brain Stimulation in Movement Disorders
- ACRONYM
- hypothesisAdaptive Deep Brain Stimulation (DBS) based on neurophysiological biomarkers is equally effective as continuous DBS with less side-effects and energy consumption.
- Healt Condition(s) or Problem(s) studiedParkinson's disease
- Inclusion criteriasound 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
- Exclusion criteriaall contra-indications that apply to normal DBS surgery (eg pregnancy, life expectancy of less than one year)
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-jan-2018
- Target number of participants16
- InterventionsIntervention:
- application of adaptive deep brain stimulation
Control interventions:
- continous stimulation
- no stimulation
- Primary outcomeblinded Unified Parkinsonís Disease Rating Scale part III score
- Secondary outcomeI blinded Speech Intelligibility Test score
II blinded Unified Dyskinesia Rating Scale
III amount of stimulation
- TimepointsPrimary: after 15 minutes of stimulation
Secondary I: after 20 minutes of stimulation
Secondary II: after 15 minutes of stimulation
Secondary III: 15 minute interval
- Trial web sitena
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD PhD M Beudel
- CONTACT for SCIENTIFIC QUERIESMD PhD M Beudel
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Hersenstichting Nederland
- PublicationsLittle S, Beudel M, Zrinzo L, et al. Bilateral adaptive Deep Brain Stimulation is effective in Parkinsonís disease. J Neurol Neurosurg Psychiatr. 2015 (In Press)
- Brief summaryRationale: Deep brain stimulations (DBS) is an established treatment for movement disorders like Parkinsonís 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 Parkinsonís disease.
- Main changes (audit trail)
- RECORD9-sep-2015 - 22-nov-2015


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