NCT05179187

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
4mo left

Started Jul 2022

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Jul 2022Sep 2026

First Submitted

Initial submission to the registry

December 16, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 6, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

4.2 years

First QC Date

December 16, 2021

Last Update Submit

January 5, 2026

Conditions

Keywords

movementexternal cueingbrain mapping

Outcome Measures

Primary Outcomes (3)

  • EEG recordings

    EEG power in the beta band

    baseline

  • BOLD fMRI: functional brain connectivity

    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

    Diffusion tensor fractional anisotropy as a function of behavioral benefits from external cues

    up to 4 weeks

Study Arms (2)

Parkinson disease patients

EXPERIMENTAL

Participants diagnosed with Parkinson's disease

Behavioral: Movement task

Healthy adults

ACTIVE COMPARATOR

Healthy adult age-matched controls

Behavioral: Movement task

Interventions

Movement taskBEHAVIORAL

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

Also known as: Computer task
Healthy adultsParkinson disease patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Dementia as indicated by score on Montreal Cognitive Assessment \< 19
  • Active hallucinations or psychosis
  • Contraindications to MRI (metal implant, claustrophobia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: All participants undergo the same behavioral interventions in which upper extremity movements are made in response to different sensory stimuli.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Residence

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 5, 2022

Study Start

July 6, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

De-identified resting state data and diffusion tractography (in raw form) will be available through the LONI Imaging and Data Archive (IDA) along with details of acquisition methods and clinical data and distributed upon approval by the PI. Electrophysiological and behavioral data obtained during task performance will be made available upon request to Dr. Cross (PI) via secured server access. Data sharing agreement will be required for all requests.

Locations