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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179187
• Other study ID #: 19-002135
• Secondary ID: 1K23NS119568
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2022
• Est. completion date: September 2026

Study information

• Verified date: December 2023
• Source: University of California, Los Angeles
• Contact: Katy Cross, MD, PhD
• Phone: 310-206-2828
• Email: kcross[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Movement task
Computer task with experimental conditions manipulating sensory and motivation cues for movement.

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG recordings	EEG power in the beta band	baseline
Primary	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
Primary	Diffusion tractography imaging (MRI): structural brain connectivity	Diffusion tensor fractional anisotropy as a function of behavioral benefits from external cues	up to 4 weeks