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Effects of Excitatory and Inhibitory LIFUS of GPi in Parkinsonian Patients Without DBS

Effects of Excitatory and Inhibitory LIFUS of GPi in Parkinsonian Patients Without DBS

Recruiting
18-90 years
All
Phase N/A

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Overview

Low intensity focused ultrasound (LIFUS) is a novel non-invasive brain stimulation (NIBS) technique that permits stimulation with high spatial focality and can reach greater depth compared other methods. This study will look at the effects of two different LIFUS stimulations on task performance in patients with Parkinson's disease. The effects of real stimulation will also be compared to sham stimulation. The evaluations will include behavioral tasks on the computer, the Unified Parkinson's Disease Rating Scale (UPDRS) motor scoring, and finger accelerometry recordings. These will be done before the LIFUS simulations and repeated after. This is to evaluate the different mechanisms and efficacy of these stimulations on deep brain areas.

Description

The goal of this study is to evaluate the effects of two different deep brain LIFUS protocols on task performance in PD patients. We will use two different protocols (5 Hz theta Burst vs 10 Hz inhibitory), bilaterally on the GPi of PD patients in two different sessions and evaluate their performance in visuomotor tasks using stop signal paradigm. We will also use active sham in a separate session bilaterally on the occipital cortex, more specifically Brodmann area 19 to compare differences in tremor activity. We will record behavioral performance of the patients to disentangle effects of different TUS protocols on PD patients. We will also use finger accelerometer on the tremor dominant hand, to evaluate possible changes in tremor.

For each participant, there will be four visits. In the first visit, a structural MRI scan will be obtained. In the subsequent three visits, the LIFUS experiments including the behavioral tasks on the computer, UPDRS motor scoring, and finger accelerometry recordings will be conducted in random order. In these visits, the task performance (stop-signal task) will be recorded before and after applying the 3 different LIFUS paradigms: 1) theta burst TUS of the GPi in one session, 2) 10Hz TUS of the GPi in one session, and 3) active sham condition in the occipital cortex (bilateral) where we will use theta burst LIFUS to the Brodmann area 19 at a TPO distance of \~30mm. Visits 2, 3, and 4 will be separated by at least 1 week each and theta burst TUS (2 minutes x2 =4 min), 10 Hz protocol (Burst length 30ms, period 1000, 30% dc. Total Time: 40 seconds x2= 80 seconds) and sham theta bust TUS will be tested in random order.

Eligibility

Inclusion Criteria:

  • 18-90 years of age
  • Confirmed diagnosis of Parkinson's disease
  • Stable dopaminergic medication dose for a minimum of 4 weeks

Exclusion Criteria:

  • History of stroke or seizure
  • Comorbid dementia
  • Scored below 22 on the Montreal Cognitive Assessment (MoCA)
  • Has intracranial implant(s) or device(s)
  • Has an implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
  • Has a previous surgical intervention to treat the movement disorder such as lesioning or a Deep Brain Stimulation system in place.
  • Presence of metal implanted in body that is contraindicated in TMS/MRI/peripheral electrical stimulation
  • Pregnancy
  • Major depression/psychiatric disorder that in the opinion of the Investigator will affect patient's understanding of study procedures and willingness to abide by all procedures during the course of the study
  • Is on antipsychotics, anti-depressants, marijuana, or other recreational drugs that affect the nervous system
  • Major musculoskeletal or neuromuscular disease or disorder of the hands, wrists and limbs
  • Severe Dyskinesia
  • Major systemic illness or infection

Study details
    Parkinson Disease (PD)

NCT07846007

University Health Network, Toronto

20 October 2026

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