The influence of stress on Parkinson's tremor

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004629-18-NL

Enrollment

Registered

2017-01-17

Start date

2017-04-13

Completion date

Unknown

Last updated

2022-05-30

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

Conditions

Tremor in Parkinson's disease

Interventions

Trade Name: Propranolol Product Name: Propranolol HCl CF 40 mg tablet Product Code: RVG 55618 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the critical role of the locus coeruleus-noradrenaline system in the pathophysiology of Parkinson’s tremor. ;Secondary Objective: - To test the ability of propranolol to inhibit stress-induced resting tremor. - 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)	—

Measure

Time frame

Main Objective: To describe the critical role of the locus coeruleus-noradrenaline system in the pathophysiology of Parkinson’s tremor. ;Secondary Objective: - To test the ability of propranolol to inhibit stress-induced resting tremor. - 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)

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Secondary

Measure	Time frame
Secondary end point(s): - Change in clinical tremor score (UPDRS) - 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)	—

Countries

Netherlands

Contacts

Public ContactAdministration

Radboud, Donders Institute

0031243610750

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026