Recruiting

TUS

Sponsor:

University Health Network, Toronto

Code:

NCT05965960

Conditions

Parkinson Disease

Essential Tremor

Dystonia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TUS Active

TUS Sham

Study Details

Brief summary:

Transcranial Ultrasound Stimulation (TUS) is an emerging non-invasive brain stimulation(NIBS) technique that can be used on both superficial and deep brain targets with a high spatial resolution as small as a few cubic millimeters. Neural correlates of TUS have yet been elucidated. To date, no intracranial recordings (i.e., local field potential \[LFP\]) have been captured during or after TUS in patients with movement disorders. In this study, we are aiming to profile basal ganglia LFP activity during and after TUS by using a DBS system that is capable of recording LFP. This can shed light on mechanisms of TUS, as well as allow identification of a neurophysiological biomarker that can be used to tune the TUS sonication parameters for future clinical trials.

Conditions

Parkinson Disease

Essential Tremor

Dystonia

Study ID

NCT05965960

Start date

May 18, 2023

Status verified date

Jul, 2023

Completion date

Jun 1, 2024

Anticipated

Primary completion date

Jun 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult patients with movement disorders (diagnosed by a movement disorder specialist)
2. Implantation of a Percept PC DBS system at least one month before the sonications
3. Stable dopaminergic medication dose for a minimum of 4 weeks

Exclusion Criteria:

1. Concomitant neurological conditions (stroke, seizure, dementia, major depression / psychiatric disorders, active drug abuse/addiction and major neuromuscular/musculoskeletal diseases)
2. Declined cognitive scores (MoCA score < 22)
3. Implants (cardiac pacemaker, implantable cardioverter-defibrillator, intracranial devices other than DBS system such as shunts and MR-unsafe devices)
4. History of intracranial lesioning procedures
5. Major systemic illness, infection or pregnancy

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Active Low Intensity Transcranial Focused Ultrasound

NeuroFUS device stimulation with 4 channel transducer Stimulation target = M1/GPi Stimulation parameters = Theta burst protocol and 30 Watts

sham comparator: Sham Low Intensity Transcranial Focused Ultrasound

NeuroFUS device stimulation with 4 channel transducer Stimulation target = M1/GPi Stimulation parameters = Theta burst protocol and 0 Watts

Interventions

TUS Active

Bilateral M1s/GPis will be sonicated using NeuroFUS device for two minutes per hemisphere with theta burst protocol and 30 W/cm2 Isppa

TUS Sham

Bilateral M1s/GPis will be sonicated using NeuroFUS device for two minutes per hemisphere with theta burst protocol and 0 W/cm2 Isppa

Primary outcome measure

  • LFP power (Experiment 1) [ Time Frame: 5 minutes long recordings during both study visits at 1) Baseline (20-30 minutes before sonication), 2) during sonication, 3) 10 minutes after sonication, 4) 30 minutes after sonication, and 5) 45 minutes after sonication ]
  • Stimulation artifact (Experiment 2) [ Time Frame: Online during sonications ]

Central Contacts and Locations

Central contacts

Julian Kwok

1 416 603 5800julian.kwok@uhn.ca

Can Sarica, MD

1 437 777 2269can.sarica@mail.utoronto.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Julian Kwok

1 416 603 580julian.kwok@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 10, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2023-10-10.