No registrations found.
ID
Source
Brief title
Health condition
Parkinson's disease; tremor; fMRI; GABA
Sponsors and support
Donders Institute for Brain, Cognition and Behaviour, Centre for Cognitive Neuroimaging
Intervention
Outcome measures
Primary outcome
- fMRI activity (cerebral activity related to the onset and the amplitude of each patient’s tremor episodes).
- GABA concentration in the ventrolateral thalamus contralateral to the tremulous arm.
- structural integrity of the mesencephalon contralateral to the tremulous arm.
Secondary outcome
- Cognitive performance on dopamine-dependent and dopamine-independent
behavioural tasks.
- Electrophysiological markers of dopa-responsive and dopa-resistant tremor (EMG).
Study objective
We hypothesize that PD patients with dopa-responsive and dopa-resistant tremor have different tremor-related brain activity, different inter-regional functional connectivity, and different GABA-ergic tone in the thalamus.
Study design
not applicable. Comparison of 2 sessions (intervention vs. placebo).
Intervention
Levodopa-Benserazide (Madopar) 200-50 mg + Domperidone 10 mg.
Helmich
PO Box 9101,
Nijmegen
The Netherlands
+31-24-3616600
Helmich
PO Box 9101,
Nijmegen
The Netherlands
+31-24-3616600
Inclusion criteria
PHASE 1 (polymography):
- Idiopathic Parkinson's disease according to UK brain bank criteria.
- Mild to moderate disease severity (Hoehn and Yahr 1-3).
- Presence of a clear resting tremor of at least one arm (UPDRS tremor-score >= 2).
PHASE 2 (neuroimaging):
- Dopaminergic therapy with a clear clinical response of non-tremor symptoms (improvement of total limb bradykinesia on the UPDRS >= 20% after 250 mg levodopa-benserazide).
- Dopamine-responsive tremor (improvement of total limb resting tremor score on the UPDRS >= 60% after 250 mg levodopa-benserazide) OR dopamine-resistant tremor (improvement of total limb resting tremor score on the UPDRS <= 20% after 250 mg levodopa-benserazide).
Exclusion criteria
- Neurological or psychiatric co-morbidity (e.g. stroke, depression).
- Severe head tremor or dyskinesias.
- Cognitive impairment (MMSE < 26).
- Neurological or psychiatric co-morbidity (e.g. stroke, depression).
- Severe head tremor or dyskinesias.
- Cognitive impairment (MMSE < 26).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4940 |
| NTR-old | NTR5042 |
| CCMO | NL47614.091.14 |
| OMON | NL-OMON40810 |