LIFUP for Treatment of Motor Deficits in Parkinson's Disease (LIFUP PD)

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Sham LIFUP Treatment; Device: Active LIFUP Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04593875

IRB#20-001901

Details and patient eligibility

About

The study will test the feasibility of using Low Intensity Focused Ultrasound Pulsation (LIFUP) to treat motor symptoms in Parkinson's Disease (PD). LIFUP is a new technique that can increase brain activity in highly specific target areas and is MRI compatible. Thus, in real-time, it is possible to directly observe how LIFUP changes the brain areas important in PD by measuring its effects on brain activity, blood flow, and brain connectivity. If successful, this research will mark the first step towards a novel, non-invasive, non-medication treatment for PD.

Full description

This trial is a proof-of-concept, proof-of-mechanism study of a novel neuromodulation technology - LIFUP - to treat motor symptoms in PD. Much like Deep Brain Stimulation, LIFUP can be focused on deep brain structures with high spatial accuracy, including those implicated in PD; however, it can do so non-invasively. Other non-invasive neuromodulation tools such as Transcranial Magnetic Stimulation can only target surface brain structures and are not optimal PD treatment tools. This study will test this new technology in 30 participants with PD during simultaneous resting state functional MRI, and collect pre- and post-LIFUP functional MRI, arterial spin labeling, motor performance data, and behavioral data, in a double-blind crossover trial to determine whether LIFUP: 1) will improve motor symptoms during and after treatment; 2) can modulate neural activity in the target brain region important for PD, the internal globus pallidus; and 3) enhance cortico-striatal motor circuit connectivity. All participants in this study will receive active ultrasound at one of the two in-person sessions and sham at the other.

Enrollment: 31 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of Parkinson's disease
2. Age 18-85
3. Fluent in the English language

Exclusion criteria

1. Metal implants that are not MR compatible
2. Neurological diagnosis other than Parkinson's
3. Not fluent in the English language

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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31 participants in 2 patient groups

Active, then Sham

Experimental group

Description:

Active Low intensity focused ultrasound pulsation (LIFUP) will be administered to the internal globus pallidus while participants are in the MRI scanner. Then, 2 weeks later, sham LIFUP will be administered.

Treatment:

Device: Active LIFUP Treatment

Device: Sham LIFUP Treatment

Sham, then Active

Experimental group

Description:

Sham low intensity focused ultrasound pulsation (LIFUP) will be administered while participants are in the MRI scanner. Then, 2 weeks later, active LIFUP will be administered to the internal globus pallidus.

Treatment:

Device: Active LIFUP Treatment

Device: Sham LIFUP Treatment