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Differences between dopa-responsive and dopa-resistant Parkinson's tremor


- candidate number21598
- NTR NumberNTR5042
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2015
- Secondary IDsNL47614.091.14 
- Public TitleDifferences between dopa-responsive and dopa-resistant Parkinson's tremor
- Scientific TitleCerebral mechanisms of dopa-responsive and dopa-resistant Parkinson¡¯s resting tremor
- ACRONYMTREMOR-DOPA
- hypothesisWe 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.
- Healt Condition(s) or Problem(s) studiedParkinson's disease, Tremor, fMRI
- Inclusion criteriaPHASE 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).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 23-jan-2015
- planned closingdate23-jan-2017
- Target number of participants50
- InterventionsLevodopa-Benserazide (Madopar) 200-50 mg + Domperidone 10 mg.
- 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).
- Timepointsnot applicable. Comparison of 2 sessions (intervention vs. placebo).
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Helmich
- CONTACT for SCIENTIFIC QUERIESDr. Helmich
- Sponsor/Initiator Radboud University Medical Center Nijmegen, Donders Institute for Brain, Cognition, and Behaviour, Centre for Cognition, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Dutch Brain Foundation (Hersenstichting)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD21-jan-2015 - 25-apr-2015


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