Test whether aDBS is superior to continuous DBS (cDBS) in terms of effectiveness, side-effects and energy consumption in patients with Parkinson*s disease (PD) and dystonia.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PD
clinical effect of aDBS compared placebo and cDBS based on blinded clinical
ratings
dystonia:
feasibility and tolerability of aDBS based on LFP low-frequency power
Secondary outcome
PD
side effect profile of aDBS compared to cDBS and placebo
energy consumption of aDBS compared to cDBS
dystonia:
effect of aDBS on subcortico-muscular coherence and clinical ratings
energy consumption of aDBS compared to cDBS
Background summary
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.
Study objective
Test whether aDBS is superior to continuous DBS (cDBS) in terms of
effectiveness, side-effects and energy consumption in patients with Parkinson*s
disease (PD) and dystonia.
Study design
PD: Double-blind head-to head placebo controlled intervention study. Dystonia:
pilot study.
Intervention
Application of adaptive DBS (aDBS) in patients who have already implanted DBS
electrodes.
Study burden and risks
PD
During the DBS battery replacement surgery patient will stay in theatre for 90
minutes longer than usual. During this 90 minutes patients will mainly undergo
clinical testing during a new form of stimulation which is proven safe. Given
the sterile environment in theatre, there is virtually no increased risk of
infections and there are no extra surgical procedures required. Patients will
be tested OFF medication. This will exaggerate symptoms to certain extend.
Dystonia
In dystonia, aDBS will be applied after the placement of the DBS electrodes but
before the battery placement. In dystonia the experimental procedure will last
approximately 15 minutes and the burden and risks is similar to that of the PD
patients.
All patients
There is no direct benefit from participation in the study. However, given the
current DBS hardware developments it is very likely that new adaptive
strategies can be applied within the next five years.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
PD
- 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
Dystonia:
- sound of mind
- eligible for DBS surgery
- ability to provide written informed consent
- dystonia in at least one muscle that is suitable for prolonged EMG recording
Exclusion criteria
all contra-indications that apply to normal DBS surgery (eg pregnancy, life expectancy of less than one year)
< 18 yo
other disorder that interferes with clinical assessment
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 |
|---|---|
| CCMO | NL54475.042.15 |
| Other | NTR nummer volgt |