Parkinson DiseaseTwinBrainPDNCT05477654
Motor-cognitive Dual-task in Healthy Older Adults and Early Parkinson's Disease Patients
An observational study of Parkinson Disease and Motor Disorders, run by Science and Research Centre Koper at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Motor Disorders, Cognitive Impairment
- What is being tested?
- Extensive motor-cognitive testing protocol
- How many people
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Aug 2022to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include healthy age-matched controls and patients with an early diagnosis of Parkinson's disease.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parkinson Disease, Motor Disorders, Cognitive Impairment
- Being tested
- Extensive motor-cognitive testing protocol
- Medical subject headings
- Parkinson Disease, Motor Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensive motor-cognitive testing protocolDiagnostic test
Screening of their functional performance while monitoring brain and muscle activity
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Patients with an early diagnosis of Parkinson's disease Receives: Diagnostic Test: Extensive motor-cognitive testing protocol | |
| Healthy controls | Healthy controls who are age-matched Receives: Diagnostic Test: Extensive motor-cognitive testing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
dual-task costs while walking
Test for dual-task costs associated with the concurrent execution of overground walking and a secondary cognitive task
Measured: 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
Measured: 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
Measured: Day 1
Secondary outcomes (1)
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science and Research Centre Koper
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Berlin, University of Geneva, Switzerland, University of Trieste, University Maribor
- Responsible party
- Principal investigator, Marusic, Science and Research Centre Koper
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477654
- Sponsor's protocol ID
- TwinBrainPDstudy
- Acronym
- TwinBrainPD
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38009088
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TwinBrain Parkinson's Disease Clinical Trial
- ClinicalTrials.gov ID
- NCT05477654
- Acronym / sponsor ID
- TwinBrainPD / TwinBrainPDstudy
- Conditions
- Parkinson Disease, Motor Disorders, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Science and Research Centre KoperUniversity, hospital or other
- Collaborators
- Technische Universität Berlin, University of Geneva, Switzerland, University of Trieste, University Maribor
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Diagnostic Test: Extensive motor-cognitive testing protocolPatients with an early diagnosis of Parkinson's disease |
| Healthy controls | – | Diagnostic Test: Extensive motor-cognitive testing protocolHealthy controls who are age-matched |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include healthy age-matched controls and patients with an early diagnosis of Parkinson's disease.
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extensive motor-cognitive testing protocolScreening of their functional performance while monitoring brain and muscle activity | Diagnostic test | Healthy controls, Parkinson's disease patients |
Primary outcome
dual-task costs while walking
Time frame: Day 1
Test for dual-task costs associated with the concurrent execution of overground walking and a secondary cognitive task
dual-task costs while standing
Time frame: Day 1
Test for dual-task costs associated with the concurrent execution of semi-tandem stance and a secondary cognitive task
dual-task costs while execution of isometric task
Time frame: Day 1
Test for dual-task costs associated with the concurrent execution of isometric contraction and a secondary cognitive task
1 secondary outcome
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Derived from this study: PubMed 38009088Marusic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Motor Disorders, run by Science and Research Centre Koper at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uros Marusic, PhD (+386 5 66 37 700, uros.marusic@zrs-kp.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dual-task costs while walking (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05477654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.