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Investigating LFP Correlates of TUS in Patients With Movement Disorders (TUS-LFP)

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ClinicalTrials.gov Identifier: NCT05965960
Recruitment Status : Recruiting
First Posted : July 28, 2023
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Essential Tremor Dystonia Device: TUS Active Device: TUS Sham Not Applicable

Detailed Description:

Experiment 1: Subjects will be randomly assigned to either the sham or active stimulation group during the first study visit. In the second study visit, there will be a crossover between the groups, with all subjects undergoing one sham and one active stimulation visit before the study is completed. During the active stimulation visit, a theta burst protocol (Isppa: 30 W/cm2, burst length: 20 ms, period: 200 ms, frequency 500 kHz) will be used to sonicate the bilateral primary motor cortices (M1) or globus pallidus interna (GPi) for 2 minutes. The sham group involves sonications performed with the power set to 0 watts over bilateral M1s/GPis. In both groups, the subjects will be masked using white noise transmitted through earbuds. The targets will be identified anatomically using structural MRIs and a neuronavigation system.

The Percept PC DBS system will be used to record local field potentials (LFPs) from the subthalamic nucleus (STN) or globus pallidus internus (GPI) at various time points: before (baseline) and during the sonications, as well as at 10-, 30-, and 45-minute intervals after the sonications. These recordings will be obtained while the subjects engage in a finger tapping task monitored by an accelerometer, as well as during resting periods. The power of LFPs across different frequencies will be compared and correlated with the velocity observed during the finger tapping task.

Following the completion of sham and active stimulation visits, the subjects will have the opportunity to participate in an optional control group visit, which entails sonication of the occipital cortex utilizing the theta burst protocol.

Experiment 2: TUS will be utilized to target the area directly over the DBS lead, while concurrently recording LFPs to identify any stimulation artifact indicative of target area-sonication engagement.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Investigating Local Field Potential Correlates of Transcranial Ultrasound Stimulation in Patients With Movement Disorders
Actual Study Start Date : May 18, 2023
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : June 1, 2024

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Arms and Interventions
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Arm Intervention/treatment
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
 Device: 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
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
 Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    The change of power of LFPs across different frequencies

  2. Stimulation artifact (Experiment 2) [ Time Frame: Online during sonications ]
    Presence of a stimulation artifact during LFP recordings


Secondary Outcome Measures :
  1. UPDRS (Experiment 1) [ Time Frame: 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). ]
    Change of UPDRS score

  2. Finger tapping task (Experiment 1) [ Time Frame: 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 ]
    Correlation of LFP power change with the velocity change during finger tapping task as recorded by an accelerometer

  3. Adverse effect profile (Experiment 1 and 2) [ Time Frame: From the initiation of the study up to 1 day after its completion. ]
    Presence of adverse effects as reported subjectively by the patient


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05965960


Contacts
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Contact: Julian Kwok 1 416 603 5800 ext 2708 julian.kwok@uhn.ca
Contact: Can Sarica, MD 1 437 777 2269 can.sarica@mail.utoronto.ca

Locations
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Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Julian Kwok    1 416 603 580 ext 2708    julian.kwok@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Robert Chen, MBBS University Health Network, Toronto
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT05965960    
Other Study ID Numbers: 20-5740#2
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Movement Disorders
Essential Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Synucleinopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations