To test the hypothesis that apathy after STN DBS may be reversed by switching the activated contact on the DBS-electrode from a ventral to a more dorsal contact.
ID
Bron
Verkorte titel
Aandoening
Parkinson's Disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is the comparison of the SAS score following one month of DBS on the original contact and the SAS score following one month of DBS on the more dorsal contact.
Achtergrond van het onderzoek
A multicenter double blind randomized crossover study in PD patients with STN DBS, comparing severity of apathy between the experimental dorsal stimulation setting and the original stimulation settings.
Doel van het onderzoek
To test the hypothesis that apathy after STN DBS may be reversed by switching the activated contact on the DBS-electrode from a ventral to a more dorsal contact.
Onderzoeksopzet
baseline, +1 month, +2 months
Onderzoeksproduct en/of interventie
26 PD patients will be randomly assigned to one of two arms. Arm-A will undergo 1 month of dorsal stimulation (intervention) followed by 1 month of regular stimulation (control). Arm-B will undergo 1 month of regular stimulation followed by 1 month of dorsal stimulation.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients suffering from Parkinson’s disease.
2. At least three months of STN DBS surgery.
3. Apathy — i.e., a 14 or more points on the SAS in PD patients.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Peri-operative intracerebral complications related to SNT-DBS placement (e.g., bleeding or infection) inflicting permanent changes.
2. Dementia (MOCA score of 25 or less)
3. Patients who are not sufficient in the Dutch language
4. Patients who are already stimulated on the most dorsal contact point on both electrodes
4. Legally incompetent adults
5. No signed informed consent
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8279 |
| Ander register | METC AMC : METC2019_150 |