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How Cerebral Plasticity Shapes Symptom Progression in Parkinson's Disease: A Longitudinal Neuroimaging Study

How Cerebral Plasticity Shapes Symptom Progression in Parkinson's Disease: A Longitudinal Neuroimaging Study - Symptom Progression in PD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46228
Enrollment
120
Registered
2018-12-06
Start date
2019-01-31
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

None listed

Sponsors

Radboud Universiteit Nijmegen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: General: 1) *40 years old. 2) Able to read and understand Dutch. 3) Subject is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule. Parkinson's Disease-specific: 1) Participation in motor and reward tasks Personalized Parkinson Project (NL59694.091.16) 2) Subject has Parkinson*s disease of *5 years* duration, defined as time since diagnosis made by a neurologist.

Exclusion criteria

Exclusion criteria: 1) Subject has co-morbidities that would hamper interpretation of parkinsonian disability or task performance, such as coincident musculoskeletal abnormalities, in the opinion of the investigator. 2) Contraindicated for MRI, e.g., claustrophobia, presence of an active implant, pacemaker, insulin pump, neurostimulator, ossicle prosthesis, pregnancy, and/or other medical device or other non-removable metal part incompatible with MRI.

Design outcomes

Primary

MeasureTime frame
For this study, we will assess 50 patients with PD once (OFF their dopaminergic medication) and 50 healthy volunteers twice (baseline and two-year follow up). We will use a subset of the protocols used in the PPP, in which 650 PD patients are assessed ON their dopaminergic medication. This protocol includes two functional MRI tasks (motor task in first half (n=325) of patients, reward task in second half (n=325) of patients) that quantify both (dysfunctional) processing in the basal ganglia and (compensatory) processing in the cortex (i.e. parietal cortex for the motor task, orbito-frontal cortex for the reward task). We will quantify clinical disease progression with clinical measures such as the MDS-UPDRS.

Secondary

MeasureTime frame
Secondary study parameters include participant characteristics (e.g. Age, Gender, Comorbidity, Medication use), clinical measures (e.g. severity of motor, cognitive and neuropsychiatric symptoms), and additional MRI-measures (Resting state functional connectivity, Diffusion tensor imaging, Quantitative susceptibility imaging and fluid-attenuated inversion recovery) to be used for thorough interpretation of primary outcomes.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)