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

NCT05477654 | Unknown

• 1 other identifier: TwinBrainPDstudy
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Motor Disorders; Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  Day 1

Study Arms (2)

Parkinson's disease patients

Patients with an early diagnosis of Parkinson's disease

Diagnostic Test: Extensive motor-cognitive testing protocol

Healthy controls

Healthy controls who are age-matched

Diagnostic Test: Extensive motor-cognitive testing protocol

Interventions

Extensive motor-cognitive testing protocol DIAGNOSTIC_TEST

Screening of their functional performance while monitoring brain and muscle activity

Healthy controls; Parkinson's disease patients

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Science and Research Centre Koper: lead
• Technische Universität Berlin: collaborator
• University of Geneva, Switzerland: collaborator
• University of Trieste: collaborator
• University Maribor: collaborator

Study Sites (1)

Science and research centre Koper

Koper, 6000, Slovenia

Location

Related Publications (1)

• Marusic U, Peskar M, Somen MM, Kalc M, Holobar A, Gramann K, Wollesen B, Wunderlich A, Michel C, Miladinovic A, Catalan M, Buoite Stella A, Ajcevic M, Manganotti P. Neuromuscular assessment of force development, postural, and gait performance under cognitive-motor dual-tasking in healthy older adults and people with early Parkinson's disease: Study protocol for a cross-sectional Mobile Brain/Body Imaging (MoBI) study. Open Res Eur. 2023 Nov 10;3:58. doi: 10.12688/openreseurope.15781.3. eCollection 2023.

  PMID: 38009088 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Central Study Contacts

Uros Marusic, PhD

CONTACT

+386 5 66 37 700; uros.marusic@zrs-kp.si

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 28, 2022
• Study Start: August 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: October 30, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)