Investigating LFP Correlates of TUS in Patients With Movement Disorders

NCT05965960 | Unknown

• 1 other identifier: 20-5740#2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• LFP power (Experiment 1)

  The change of power of LFPs across different frequencies

  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)

  Presence of a stimulation artifact during LFP recordings

  Online during sonications

Secondary Outcomes (3)

• UPDRS (Experiment 1)

  Two assessments will be conducted during each study visit: one at baseline (within the first minute of the study) and the other upon completion of the study visit (between 120 and 130 minutes after the study visit initiation).

• Finger tapping task (Experiment 1)

  LFPs during finger tapping will be recorded at each visit for half minute at 1) Baseline (20-30 minutes before sonication), 2) 10 minutes after sonication, 3) 30 minutes after sonication, and 4) 45 minutes after sonication

• Adverse effect profile (Experiment 1 and 2)

  From the initiation of the study up to 1 day after its completion.

Study Arms (2)

Active Low Intensity Transcranial Focused Ultrasound

ACTIVE COMPARATOR

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

Device: TUS Active

Sham Low Intensity Transcranial Focused Ultrasound

SHAM COMPARATOR

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

Device: TUS Sham

Interventions

TUS Active DEVICE

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

Active Low Intensity Transcranial Focused Ultrasound

TUS Sham DEVICE

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

Sham Low Intensity Transcranial Focused Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor; Dystonia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Chen, MBBS

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Kwok

CONTACT

1 416 603 5800; julian.kwok@uhn.ca

Can Sarica, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The subject will be blind to stimulation condition (sham/active TUS). The assessor will be blind to stimulation condition (sham/active TUS) while analyzing LFPs. The UPDRS examination will be video-recorded and blindly assessed by a research team member.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 28, 2023
• Study Start: May 18, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)