Non-invasive Brain Mapping of Movement Facilitation in Parkinson's Disease

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT05179187

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Several strategies or contexts help patients with Parkinson's disease to move more quickly or normally, however the brain mechanisms underlying these phenomena are poorly understood. The proposed studies use complimentary brain mapping techniques to understand the brain mechanisms supporting improved movements elicited by external cues. The central hypothesis is that distinct networks are involved in movement improvement depending on characteristics of the facilitating stimulus. Participants will perform movement tasks during recording of brain activity with EEG and MRI. The identified biomarkers may provide targets for future neuromodulation therapies to improve symptoms that are refractory to current treatments, such as freezing of gait.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Behavioral: Movement task	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All participants undergo the same behavioral interventions in which upper extremity movements are made in response to different sensory stimuli.All participants undergo the same behavioral interventions in which upper extremity movements are made in response to different sensory stimuli.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Non-invasive Brain Mapping of Movement Facilitation in Parkinson's Disease

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Parkinson disease patients Participants diagnosed with Parkinson's disease	Behavioral: Movement task Computer task with experimental conditions manipulating sensory and motivation cues for movement. Other Names: Computer task
Active Comparator: Healthy adults Healthy adult age-matched controls	Behavioral: Movement task Computer task with experimental conditions manipulating sensory and motivation cues for movement. Other Names: Computer task

Arm

Intervention/Treatment

Experimental: Parkinson disease patients

Participants diagnosed with Parkinson's disease

Behavioral: Movement task

Computer task with experimental conditions manipulating sensory and motivation cues for movement.

Other Names:

Computer task

Active Comparator: Healthy adults

Healthy adult age-matched controls

Behavioral: Movement task

Computer task with experimental conditions manipulating sensory and motivation cues for movement.

Other Names:

Computer task

Outcome Measures

Primary Outcome Measures

EEG recordings [baseline]
EEG power in the beta band
BOLD fMRI: functional brain connectivity [up to 4 weeks]
Blood oxygen level dependent (BOLD) resting state network activity as a function of behavioral benefits from external cues
Diffusion tractography imaging (MRI): structural brain connectivity [up to 4 weeks]
Diffusion tensor fractional anisotropy as a function of behavioral benefits from external cues

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles	Los Angeles	California	United States	90095

Sponsors and Collaborators

University of California, Los Angeles
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kathryn A. Cross, MD, PhD, Assistant Professor in Residence, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT05179187

Other Study ID Numbers:

19-002135
1K23NS119568

First Posted:

Jan 5, 2022

Last Update Posted:

Jan 5, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kathryn A. Cross, MD, PhD, Assistant Professor in Residence, University of California, Los Angeles

movement

external cueing

brain mapping

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Jan 5, 2022