Recruiting

LIFUS

Sponsor:

University Health Network, Toronto

Code:

NCT07846007

Conditions

Parkinson Disease (PD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LIFUS: Active 5 Hz Theta Burst

LIFUS: Active 10 Hz

LIFUS: Sham

Study Details

Brief summary:

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.

Conditions

Parkinson Disease (PD)

Study ID

NCT07846007

Start date

Feb 14, 2024

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Low Intensity Focused Ultrasound

3 different LIFUS paradigms in random order: 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.

Interventions

LIFUS: Active 5 Hz Theta Burst

LIFUS 5 Hz theta burst bilaterally on the GPi

LIFUS: Active 10 Hz

LIFUS 10 Hz bilaterally on the GPi

LIFUS: Sham

Sham: LIFUS theta burst to occipital lobe

Primary outcome measure

  • Stop-Signal Task [ Time Frame: Visits 2-4: before stimulation, 20 minutes post round 1 of stimulation, and 25 minutes post round 2 of stimulation ]

Central Contacts and Locations

Central contacts

Julian Kwok

416-603-5800julian.kwok@uhn.ca

Regina Annirood

regina.annirood@uhn.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T2S8

Contacts

Julian Kwok

416-603-5800julian.kwok@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.