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

Parkinson Disease Clinical Trial

— TwinBrainPD  

Official title:

TwinBrain Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05477654
• Other study ID #: TwinBrainPDstudy
• Status: Not yet recruiting
• Start date: August 1, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: July 2022
• Source: Science and Research Centre Koper
• Contact: Uros Marusic, PhD
• Phone: +386 5 66 37 700
• Email: uros.marusic[@]zrs-kp.si
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 30, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Impairment
• Motor Disorders
• Parkinson Disease

Intervention

Diagnostic Test:
• Extensive motor-cognitive testing protocol
Screening of their functional performance while monitoring brain and muscle activity

Locations

Country	Name	City	State
Slovenia	Science and research centre Koper	Koper

Sponsors (5)

Lead Sponsor	Collaborator
Science and Research Centre Koper	Technische Universität Berlin, University Maribor, University of Geneva, Switzerland, University of Trieste

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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