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

Explorations into the cerebral mechanisms of dopa-responsive and dopa-resistant Parkinson*s resting tremor - Dopa-responsive vs. dopa-resistant tremor in PD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40810

Enrollment

105

Registered

2014-03-27

Start date

2014-06-06

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease tremor

Interventions

All Parkinson patients (n=80) will be tested without dopaminergic medication (their own medication stopped for at least 12 hours). On one day they will receive a placebo (with 10 mg Domperidon), on

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Neurological or psychiatric co-morbidity (e.g. stroke, depression). - Severe head tremor or dyskinesias. - Cognitive impairment (MMSE

Design outcomes

Primary

Measure	Time frame
The primary outcome measure of this study is the difference in tremor-related brain activity at rest, during a motor task, and during a simple cognitive task, with and without dopaminergic therapy, between Parkinson patients with dopa-resistant and dopa-responsive tremor.	—

Secondary

Measure	Time frame
Secondary outcome measures are the difference in GABA concentrations in the thalamus, structural integrity of the brain stem (DTI), and functional connectivity between basal ganglia and the cerebello-thalamo-cortical circuit, between both Parkinson groups and healthy controls. We will also compare tremor characteristics (frequency, distribution over the body) between Parkinson patient with dopa-responsive and dopa-resistant tremor, and we will compare cognitive performance on dopamine-sensitive and dopamine-insensitive behavioral tasks.	—

Measure

Time frame

Secondary outcome measures are the difference in GABA concentrations in the thalamus, structural integrity of the brain stem (DTI), and functional connectivity between basal ganglia and the cerebello-thalamo-cortical circuit, between both Parkinson groups and healthy controls. We will also compare tremor characteristics (frequency, distribution over the body) between Parkinson patient with dopa-responsive and dopa-resistant tremor, and we will compare cognitive performance on dopamine-sensitive and dopamine-insensitive behavioral tasks.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)