Recruiting

TUS

Sponsor:

Robert Chen

Code:

NCT07695233

Conditions

Parkinson Disease

Freezing of Gait Symptoms in Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Excitatory Stimulation

Inhibitory Stimulation

Sham

Study Details

Brief summary:

This study is investigating the use of transcranial ultrasound stimulation (TUS) on the Pedunculopontine nucleus (PPN) in changing freezing of gait in people with Parkinson's disease. The PPN is noted to be involved in voluntary movements, locomotion, and muscle tone. This will be assessed by patient-reported outcomes and analyzing the gait. The study will also investigate the effects of the stimulation on the PPN and surrounding connectivity by using magnetic resonance imaging (MRI).

Conditions

Parkinson Disease

Freezing of Gait Symptoms in Parkinson Disease

Study ID

NCT07695233

Start date

May 17, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-90 years of age
  • Confirmed diagnosis of a movement disorder with Freezing of Gait
  • 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 DBS system in place.
  • Presence of metal implanted in body that is contraindicated in TMS/MRI
  • 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, marijuana, or other recreational drugs that affect the nervous system
  • Major musculoskeletal or neuromuscular disease or disorder of the hands, wrists and limbs
  • Major systemic illness or infection

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Arm 1

All participants will receive excitatory, inhibitory, and sham stimulation to the PPN. The order that they receive it is randomized across Visits 2 - 4. All stimulation within a visit will be the same.

Interventions

Excitatory Stimulation

Excitatory Stimulation to the PPN

Inhibitory Stimulation

Inhibitory Stimulation to the PPN

Sham

Sham stimulation to PPN

Primary outcome measure

  • New Freezing of Gait Questionnaire [ Time Frame: Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation. ]
  • Timed Up-and-Go Task [ Time Frame: Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation. ]
  • ZenoTM Walkway [ Time Frame: Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation. ]

Central Contacts and Locations

Central contacts

Julian Kwok

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

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Julian Kwok

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

Principal Investigator:

Robert Chen, MD

More Information

Sponsor

Robert Chen

Last update posted

Jul 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert Chen on 2026-07-10.