Clinical trial NCT04593875: LIFUP for Treatment of Motor Deficits in Parkinson&#39;s Disease
Official title: Low-Intensity Focused Ultrasound Pulsation for Treatment of Motor Deficits in Parkinson&#39;s Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: LIFUP
Ultrasound
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be assigned to both study arms; the order in which they complete the arms will be randomized and counterbalanced. The two visits will be spaced apart by 2 weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Motor Assessment 1: Finger Tapping
timeFrame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
measure: Motor Assessment 2: 9-Hole Pegboard Dexterity Test
timeFrame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
measure: Motor Assessment 3: Unified Parkinson Disease Rating Scale (UPDRS) Section 3
timeFrame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
Secondary outcomes:
measure: BOLD fMRI Signal in Internal Globus Pallidus
timeFrame: During LIFUP (or sham) sonication on Day 1 and Day 15
measure: Perfusion throughout Brain
timeFrame: Pre-LIFUP and Post-LIFUP at Day 1 and Day 15
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Taylor P Kuhn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: