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Explorations into the cerebral mechanisms of dopa-responsive and dopa-resistant Parkinson*s resting tremor

Recruiting
Conditions
Parkinson's disease
tremor
10028037
Registration Number
NL-OMON40810
Lead Sponsor
niversitair Medisch Centrum Sint Radboud
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
105
Inclusion Criteria

- Idiopathic Parkinson*s disease according to UK brain bank criteria.
- Presence of a clear resting tremor of at least one arm (UPDRS tremor-score 2 or more).
- Dopaminergic therapy with a clear clinical response of non-tremor symptoms (bradykinesia, rigidity).
- Milde tot moderate disease severity (Hoehn and Yahr 1-3).

Exclusion Criteria

- Neurological or psychiatric co-morbidity (e.g. stroke, depression).
- Severe head tremor or dyskinesias.
- Cognitive impairment (MMSE < 26).
- General MRI exclusion criteria (e.g. pacemaker, implanted metal parts, deep brain stimulation, claustrophobia).
- Co-medication associated with elongated QT-time.
- Pregnancy.
- Age < 25 years.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary outcome measure of this study is the difference in tremor-related<br /><br>brain activity at rest, during a motor task, and during a simple cognitive<br /><br>task, with and without dopaminergic therapy, between Parkinson patients with<br /><br>dopa-resistant and dopa-responsive tremor. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary outcome measures are the difference in GABA concentrations in the<br /><br>thalamus, structural integrity of the brain stem (DTI), and functional<br /><br>connectivity between basal ganglia and the cerebello-thalamo-cortical circuit,<br /><br>between both Parkinson groups and healthy controls. We will also compare tremor<br /><br>characteristics (frequency, distribution over the body) between Parkinson<br /><br>patient with dopa-responsive and dopa-resistant tremor, and we will compare<br /><br>cognitive performance on dopamine-sensitive and dopamine-insensitive behavioral<br /><br>tasks.</p><br>
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