- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05179187
Non-invasive Brain Mapping of Movement Facilitation in Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The studies proposed here test the overarching hypothesis that different types of cues (visual targets, rhythmic auditory stimuli and reward incentives) facilitate movement through distinct neuroanatomic circuits and electrophysiological mechanisms, by leveraging known variability in behavioral cueing benefits across patients.
Aim 1 is to demonstrate behavioral dissociations between different forms of movement facilitation within patients and relate variability in cueing benefits to integrity of dissociable neuroanatomic circuits as measured by resting state and diffusion tensor magnetic resonance imaging (MRI). Aim 2 is to characterize the electrophysiological correlates of behavioral benefits for the different cue types using electroencephalography (EEG).
Patients will perform two computer tasks involving reaching and tapping movements during video recording of movements and electrophysiological recording of brain signals. Experimental manipulations involve different computer stimuli that manipulate the presence or absence of sensory and motivational movement cues. The same experimental manipulations are delivered to all individual subjects. 60 patients with Parkinson's disease and 30 healthy controls will perform the task during recording of brain waves from the scalp (EEG) and return for a second session to record brain activity with MRI. Each of the total of 2 sessions will last about 1.5 hours. Patients may be asked to delay taking their morning Parkinson's disease medications and perform clinical rating scales and questionnaires and undergo a movement disorders neurological exam.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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Los Angeles, California, United States, 90095
- University of California Los Angeles
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of Parkinson's disease based on presence of at least 2 cardinal features (tremor, rigidity or bradykinesia) OR healthy adult with no neurologic disease
- Age > 18 years old
Exclusion Criteria:
- Dementia as indicated by score on Montreal Cognitive Assessment < 19
- Active hallucinations or psychosis
- Contraindications to MRI (metal implant, claustrophobia)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parkinson disease patients
Participants diagnosed with Parkinson's disease
|
Computer task with experimental conditions manipulating sensory and motivation cues for movement.
Other Names:
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Active Comparator: Healthy adults
Healthy adult age-matched controls
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Computer task with experimental conditions manipulating sensory and motivation cues for movement.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG recordings
Time Frame: baseline
|
EEG power in the beta band
|
baseline
|
|
BOLD fMRI: functional brain connectivity
Time Frame: up to 4 weeks
|
Blood oxygen level dependent (BOLD) resting state network activity as a function of behavioral benefits from external cues
|
up to 4 weeks
|
|
Diffusion tractography imaging (MRI): structural brain connectivity
Time Frame: up to 4 weeks
|
Diffusion tensor fractional anisotropy as a function of behavioral benefits from external cues
|
up to 4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-002135
- 1K23NS119568 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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