Towards Noninvasive DBS of the Basal Ganglia in Parkinson's Disease Using TUS

Recruiting in Palo Alto (17 mi)

Overseen byRobert Chen, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?Transcranial Ultrasound Stimulation (TUS) is an emerging non-invasive brain stimulation technique capable of targeting both superficial and deep brain areas with high spatial resolution, down to a few cubic millimeters. In this study, the investigators aim to use TUS to non-invasively modulate the globus pallidus internus (GPi) in patients with Parkinson's disease (PD) and dystonia. These patients have previously been implanted with deep brain stimulation (DBS) leads. The investigators plan to simultaneously record local field potentials (LFPs) from the DBS leads using the Percept PC device (Medtronic Inc.) while the DBS is turned off. The study's goal is to investigate the mechanism of action of TUS and its neuromodulatory effects on LFPs recorded from the GPi. This will enable us to compare the effects of TUS with those of DBS.

Eligibility Criteria

This trial is for adults with Parkinson's Disease or dystonia, diagnosed by a specialist. Participants must have had a Percept PC DBS system implanted at least one month prior and been on a stable dose of dopaminergic medication for at least four weeks.

Inclusion Criteria

I have been diagnosed with a movement disorder by a specialist.

I had a Percept PC DBS system implanted at least a month ago.

My Parkinson's medication dose has been the same for at least 4 weeks.

Participant Groups

The study tests Transcranial Ultrasound Stimulation (TUS) as a non-invasive alternative to Deep Brain Stimulation (DBS). It aims to modulate brain activity in the globus pallidus internus using TUS while recording local field potentials from previously implanted DBS leads.

2Treatment groups

Active Control

Placebo Group

Group I: Active Low-Intensity Transcranial Focused UltrasoundActive Control1 Intervention

NeuroFUS device stimulation with 4-channel transducer Stimulation target = GPi Stimulation parameters = 5Hz and 10 Hz protocols at ISPPA=30 W/cm2

Group II: Sham Low-Intensity Transcranial Focused UltrasoundPlacebo Group1 Intervention

NeuroFUS device stimulation with 4-channel transducer Stimulation target = GPi and occipital cortex Stimulation parameters = for the passive sham protocol: GPi target (5Hz and 10 Hz protocols at 0 ISPPA) and for the active sham protocol: occipital target (5Hz and 10 Hz protocol at 30 ISPPA)