The influence of stress on Parkinson's tremor

Phase 1

• Conditions: Tremor in Parkinson's disease; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-004629-18-NL
• Lead Sponsor: Radboud University Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-17
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- idiopathic Parkinson’s disease according to UK Brain Bank criteria
- tremor-­dominant phenotype (defined as a resting tremor score of >= 2 UPDRS points for at least one arm)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the critical role of the locus coeruleus-noradrenaline system in the pathophysiology of Parkinson’s tremor.<br>;Secondary Objective: - To test the ability of propranolol to inhibit stress­-induced resting tremor.<br>- To identify patient-specific noradrenergic markers (functional and structural) that predict how sensitive his/her tremor is to acute psychological stress and a targeted pharmacological intervention (propranolol).;Primary end point(s): Change in tremor-related cerebral activity and connectivity (fMRI BOLD signal) ;Timepoint(s) of evaluation of this end point: At the end of the study (01-02-2022)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Change in clinical tremor score (UPDRS)<br>- Change in autonomous stress markers (salivary cortisol, heart rate, blood pressure, pupil diameter);Timepoint(s) of evaluation of this end point: At the end of the study (01-02-2022)