Improving the clinical effect and efficiency of DBS for PD by investigating patient specific patterns of neuronal cell activity in the brain that are associated with symptom-severity. This may improve the clinical effect of DBS, and also result in…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The development of a patient specific profile of neuronal activity that is
associated with the presence and severity of the symptoms, forming a *neuronal
fingerprint*.
Secondary outcome
N\A
Background summary
Deep brain stimulation (DBS) is a very efficacious treatment for Parkinson*s
disease (PD). However, the programming of DBS is a laborious process and
requires frequent hospital visits. Furthermore, current DBS protocols use
continuous electric current at constant intensity, which may hamper efficacy
and induce side-effects.
Study objective
Improving the clinical effect and efficiency of DBS for PD by investigating
patient specific patterns of neuronal cell activity in the brain that are
associated with symptom-severity. This may improve the clinical effect of DBS,
and also result in less burdensome hospital visits, thereby reducing healthcare
consumption.
Study design
A longitudinal prospective diagnostic study that will include patients with PD
who are implanted with a DBS-sensing system (PerceptTM PC, Medtronic). In the
first six months after implantation, neuronal activity will be recorded. The
data will be correlated with symptom-severity, assessed with (i) kinematic
smartwatch data, (ii) clinical rating scales and (iii) patient diaries, and
analyzed using artificial intelligence (AI) algorithms.
Study burden and risks
Patients will not directly benefit from their participation. However,
stimulation parameters might be changed after the experiment if collected data
indicates possible advantages. Disadvantage of participation is limited since
readout of the neural recordings is safe and non-invasive. The project does not
bear any risks and adds only slight discomfort of wearing a smartwatch, making
small diary notes and undergoing two extra testing moments, partly without
Parkinson's medication (off-drugs). In the AMC, participation includes five
test moments, two of which may be extra compared to care as usual. Patients are
off-drugs during visits 2 and 5, which is already the case during the normal
procedure. At the HagaZiekenhuis, the study includes six outpatient visits and
one clinical visit one day postoperatively. Of these, two visits are extra
compared to care as usual. Patients are off-drugs during all visits except
visit 4. This can cause additional symptoms of Parkinson's disease, but at that
time patients already have an active DBS system, which suppresses the symptoms
(possibly to a lesser extent than with medication).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age 18 years or older
- Diagnosed with Parkinson's Disease and eligible for DSB
- Parkinson's Disease patients receiving Medtronic PerceptTM PC STN DBS in the
care as usual setting between
Exclusion criteria
- Inability to provide informed consent
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
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In other registers
Register | ID |
---|---|
CCMO | NL80384.018.22 |