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

Sponsor
Science and Research Centre Koper (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05477654
Collaborator
Technische Universität Berlin (Other), University of Geneva, Switzerland (Other), University of Trieste (Other), University Maribor (Other)
60
1
14.9
4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Extensive motor-cognitive testing protocol

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
TwinBrain Parkinson's Disease Clinical Trial
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Oct 30, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. dual-task costs while walking [Day 1]

    Test for dual-task costs associated with the concurrent execution of overground walking and a secondary cognitive task

  2. dual-task costs while standing [Day 1]

    Test for dual-task costs associated with the concurrent execution of semi-tandem stance and a secondary cognitive task

  3. dual-task costs while execution of isometric task [Day 1]

    Test for dual-task costs associated with the concurrent execution of isometric contraction and a secondary cognitive task

Secondary Outcome Measures

  1. The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Day 1]

    Assessment of various aspects of PD including motor and non-motor experience of daily living and the related complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Science and research centre Koper Koper Slovenia 6000

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marusic, Associate professor, Science and Research Centre Koper
ClinicalTrials.gov Identifier:
NCT05477654
Other Study ID Numbers:
  • TwinBrainPDstudy
First Posted:
Jul 28, 2022
Last Update Posted:
Aug 1, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 1, 2022