The noradrenergic basis of Parkinson*s tremor: a systems-level fMRI approach

Phase 4

Completed

• Conditions: Parkinson's disease; tremor; 10028037

• Registration Number: NL-OMON55729
• Lead Sponsor: eurologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

- idiopathic Parkinson*s disease according to UK Brain Bank criteriaPatients
will fall in one of two groups (Parkinson phenotypes); either:
- tremor-­dominant phenotype (defined as a resting tremor score of ><= 2 UPDRS
points for at least one arm) or:
- non-tremor phenotype (defined as a resting tremore score of 0 points on the
UPDRS).

Exclusion Criteria

- use of beta-blockers
- neuropsychiatric co-morbidity
- contraindications for MRI scanning (e.g. pacemaker, implanted metal parts,
deep brain stimulation, claustrophobia)
- Cardiac arrhythmias (in patient history or visible on ECG)
- contraindications for beta blockers (e.g. bradycardia, peripheral circulation
disturbances, asthma or obstructive lung disease, hypotension)
- Use of medication that may interact with propranolol, e.g. other bèta-
blockers, calcium antagonists, digoxine, cimetidine, hydralazine, fluvoxamine,
rifampicine, barbiturates, amiodaron, flecainide, kinidine, propafenon,
disopyramide, chlorpromazine, and clonidine
- Use of medication that inhibits relevant CYP enzymes that are involved in
metabolizing propranolol (CYP2D6, CYP1A2, and CYP2C19): fluoxetine, paroxetine,
sertraline, duloxetine, terbinafine, cinacalcet, bupropion, and ciprofloxacine
- Severe head tremor or dyskinesias
- Cognitive impairment (MMSE < 26)
- Severe PD: disease duration > 10 years, severe ON/OFF fluctuations, or
levodopa equivalent dose >1200 mg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Tremor-related activity and connectivity (quantified using concurrent<br /><br>EMG-fMRI). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Structural integrity of the locus coeruleus (quantified using neuromelanin<br /><br>sensitive MRI).<br /><br>Functional integrity of the locus coeruleus (quantified using task fMRI).<br /><br>Clinical parameters </p><br>