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Active Low-Intensity Transcranial Focused Ultrasound for Dystonia

N/A

Waitlist Available

Led By Robert Chen, MBBS

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Implantation of a Percept PC DBS system at least one month before the sonications

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-minute long recordings at 1) baseline (10 minutes before tus), 2) during tus (lasting either 120 seconds or 40 seconds, depending on the protocol), 3) 10 minutes after tus, 4) 30 minutes after tus, and 5) 45 minutes after tus

Summary

This trial aims to use a non-invasive brain stimulation technique called Transcranial Ultrasound Stimulation (TUS) to target specific areas of the brain in patients with Parkinson's disease and dystonia

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of TUS may include discomfort at the stimulation site, headache, dizziness, or temporary hearing changes. However, since it's non-invasive and targets specific brain areas, risks are considered lower than invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-minute long recordings at 1) baseline (10 minutes before tus), 2) during tus (lasting either 120 seconds or 40 seconds, depending on the protocol), 3) 10 minutes after tus, 4) 30 minutes after tus, and 5) 45 minutes after tus

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-minute long recordings at 1) baseline (10 minutes before tus), 2) during tus (lasting either 120 seconds or 40 seconds, depending on the protocol), 3) 10 minutes after tus, 4) 30 minutes after tus, and 5) 45 minutes after tus

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-minute long recordings at 1) baseline (10 minutes before tus), 2) during tus (lasting either 120 seconds or 40 seconds, depending on the protocol), 3) 10 minutes after tus, 4) 30 minutes after tus, and 5) 45 minutes after tus for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Any treatment-related adverse events and side effects of TUS applications

Modulations in the amplitude of the LFP power spectrum

Secondary study objectives

Modulations of the aperiodic activities derived from the LFPs

Trial Design

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)

0 / 1Eligibility criteria met