Motor-cognitive Dual-task in Healthy Older Adults and Early Parkinson's Disease Patients (TwinBrainPD)

TwinBrain Parkinson's Disease Clinical Trial

Neuromuscular dysfunction is common in older adults and even more pronounced in neurodegenerative diseases. In Parkinson's disease (PD), a complex set of factors often prevents effective performance of activities of daily living that require intact and simultaneous performance of motor and cognitive tasks. In the current study we aim at employing the Mobile Brain/Body Imaging approach (MoBI) to gain further insides of neuromuscular biomarkers revealing the decrements of older adults with an early PD. The cross-sectional study will be evaluated through the multifactorial mixed-measure design.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease; Cognitive Impairment; Motor Disorders
• Intervention / Treatment: Diagnostic test: Extensive motor-cognitive testing protocol

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Uros Marusic, PhD; Phone Number: +386 5 66 37 700; Email: uros.marusic@zrs-kp.si

Study Locations

• Slovenia
  • Koper, Slovenia, 6000
    • Science and Research Centre Koper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include healthy age-matched controls and patients with an early diagnosis of Parkinson's disease.

Description

Inclusion Criteria:

Inclusion criteria for the healthy older participants will be:

• no diagnosis of cognitive or movement disorder,
• score > 7 for the Short Physical Performance Battery (SPPB),
• living independently in the community,
• age range between 55 and 70 years,
• no color blindness.

Inclusion criteria for the early-stage PD patients:

• diagnosed according to the last MDS criteria (2015),
• duration of the disease less than 5 years,
• positive DATSCAN,
• diagnosed akinetic-rigid or mixed phenotype,
• score of 1 or maximally 2 on the Hoehn and Yahr scale (Hoehn & Yahr, 1967),
• MoCA score ≥ 24 points,
• score > 7 for the SPPB,
• age range between 50 and 75 years,
• no color blindness
• living independently in the community.

Exclusion Criteria:

• advanced stages of PD (Hoehn and Yahr score > 2)
• any acute or chronic diseases, especially of the peripheral and central nervous system, heart failure, respiratory failure, severe osteoarthritis, and major psychiatric illness such as depression
• MoCA score < 24 points,
• severe disabling tremor,
• recurrent falls,
• impaired vision that is not corrected with e.g., glasses,
• low SPPB score

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's disease patients; Patients with an early diagnosis of Parkinson's disease	Diagnostic test: Extensive motor-cognitive testing protocol; Screening of their functional performance while monitoring brain and muscle activity
Healthy controls; Healthy controls who are age-matched	Diagnostic test: Extensive motor-cognitive testing protocol; Screening of their functional performance while monitoring brain and muscle activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dual-task costs while walking	Test for dual-task costs associated with the concurrent execution of overground walking and a secondary cognitive task	Day 1
dual-task costs while standing	Test for dual-task costs associated with the concurrent execution of semi-tandem stance and a secondary cognitive task	Day 1
dual-task costs while execution of isometric task	Test for dual-task costs associated with the concurrent execution of isometric contraction and a secondary cognitive task	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	Assessment of various aspects of PD including motor and non-motor experience of daily living and the related complications	Day 1

Collaborators and Investigators

• Sponsor: Science and Research Centre Koper
• Collaborators: University of Trieste; Technische Universität Berlin; University of Geneva, Switzerland; University Maribor

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Motor Disorders
• Other Study ID Numbers: TwinBrainPDstudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No