NCT07695233

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
28mo left

Started May 2024

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress49%
May 2024Dec 2028

Study Start

First participant enrolled

May 17, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3.5 years

First QC Date

February 22, 2026

Last Update Submit

July 5, 2026

Conditions

Parkinson DiseaseFreezing of Gait Symptoms in Parkinson Disease

Outcome Measures

Primary Outcomes (3)

  • New Freezing of Gait Questionnaire

    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

    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

    Mat that detects pressure data during standing and walking to evaluate gait such as speed, profile, step time, step length, strid time, stride length, and more.

    Occurs twice at Visits 2, 3, and 4. For each of those visits, it will be conducted once before stimulation and another after stimulation.

Study Arms (1)

Arm 1

ACTIVE COMPARATOR

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.

Device: Excitatory StimulationDevice: Inhibitory StimulationDevice: Sham

Interventions

Excitatory StimulationDEVICE

Excitatory Stimulation to the PPN

Arm 1
Inhibitory StimulationDEVICE

Inhibitory Stimulation to the PPN

Arm 1
ShamDEVICE

Sham stimulation to PPN

Arm 1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Confirmed diagnosis of a movement disorder with Freezing of Gait
  • Stable dopaminergic medication dose for a minimum of 4 weeks

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Robert Chen, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julian Kwok

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

February 22, 2026

First Posted

July 10, 2026

Study Start

May 17, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

July 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)