No registrations found.
ID
Source
Health condition
Parkinson’s Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
blinded Unified Parkinson’s Disease Rating Scale part III score
Secondary outcome
I blinded Speech Intelligibility Test score
II blinded Unified Dyskinesia Rating Scale
III amount of stimulation
Background summary
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.
Study objective
Adaptive Deep Brain Stimulation (DBS) based on neurophysiological biomarkers is equally effective as continuous DBS with less side-effects and energy consumption.
Study design
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
Intervention
Intervention:
- application of adaptive deep
brain stimulation
Control interventions:
- continous stimulation
- no stimulation
Inclusion criteria
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
Exclusion criteria
all contra-indications that apply to normal DBS surgery (eg pregnancy, life expectancy of less than one year)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5232 |
| NTR-old | NTR5456 |
| Other | NL54475.042.15 : ABR |