The influence of stress on Parkinson's tremor

• Register: EUCTR
• Last refreshed on: 30 May 2022
• Main ID: EUCTR2016-004629-18-NL
• Date of registration: 17/01/2017
• Prospective Registration: Yes
• Primary sponsor: Radboud University Nijmegen
• Public title: The influence of stress on Parkinson's tremor
• Scientific title: The noradrenergic basis of Parkinson’s tremor: a systems-level fMRI approach - Noradrenergic basis of Parkinson tremor
• Date of first enrolment: 13/04/2017
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004629-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: non-medicinal product (cellulose in water) Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Netherlands

Contacts

• Name: Administration
• Affiliation: Radboud, Donders Institute

• Name: Administration
• Affiliation: Radboud, Donders Institute

Key inclusion & exclusion 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:
- 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)


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Tremor in Parkinson's disease

Intervention(s)

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

Primary Outcome(s)

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)

Main Objective: To describe the critical role of the locus coeruleus-noradrenaline system in the pathophysiology of Parkinson’s tremor.

Timepoint(s) of evaluation of this end point: At the end of the study (01-02-2022)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At the end of the study (01-02-2022)

Secondary end point(s): - Change in clinical tremor score (UPDRS)
- Change in autonomous stress markers (salivary cortisol, heart rate, blood pressure, pupil diameter)

Secondary ID(s)

helmich-veni-2019

Source(s) of Monetary Support

Netherlands Organization for Scientific Research

Ethics review

Status: Approved
Approval date: 13/04/2017
Contact: