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ID
Source
Brief title
Health condition
Parkinson's Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Secondary outcomes are symptom changes on the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale motor part III (MDS-UPDRS-III), Montgomery- Åsberg Depression Rating Scale (MADRS), 39-item Parkinson’s disease Questionnaire (PDQ-39) Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire (QUIP), changes in levodopa-equivalent daily dosage (LEDD), apathy rated by the caregiver (AES-I), and burden and quality of life of the caregiver (SF-36). Imaging data available from standard clinical care (pre-operative structural and diffusion-weighted MRI scans and post-operative CT-scan) will be used to determine the locations and white matter connections of the experimental and original stimulation contact, and to correlate this contact-specific neuroanatomical information with apathy scores and effectiveness of the intervention.
Background summary
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.
Study objective
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.
Study design
baseline, +1 month, +2 months
Intervention
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.
Inclusion criteria
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.
Exclusion criteria
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
Design
Recruitment
IPD sharing statement
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 | NL8279 |
| Other | METC AMC : METC2019_150 |