Health TrialsbyHealthPanel

Pedunculopontine Nucleus Transcranial Ultrasound Stimulation as a Treatment of Freezing of Gait in Parkinson's Disease

ConditionsParkinson DiseaseFreezing of Gait Symptoms in Parkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRobert Chen

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

History of stroke or seizure

Comorbid dementia

Scored below 22 on the Montreal Cognitive Assessment (MoCA)

Has intracranial implant(s) or device(s)

Trial design

Design model

Single group

Treatments tested in this trial

  • Excitatory Stimulation

    Device

    Excitatory Stimulation to the PPN

  • Inhibitory Stimulation

    Device

    Inhibitory Stimulation to the PPN

  • Sham

    Device

    Sham stimulation to PPN

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Arm 1Active comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Robert Chen

Lead sponsor

University Health Network, Toronto

Sponsor institution

Source ClinicalTrials.gov
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