--- title: Ultrasound stimulation reduces freezing episodes nct_id: NCT07695233 phase: NA status: RECRUITING sponsor: Robert Chen study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07695233" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07695233" last_fetched: "2026-07-11T14:01:54.759Z" source: "Parkinson's Pathways (curated)" --- # Ultrasound stimulation reduces freezing episodes **Goal (in five words):** Ultrasound stimulation reduces freezing episodes **Official Title:** Pedunculopontine Nucleus Transcranial Ultrasound Stimulation as a Treatment of Freezing of Gait in Parkinson's Disease **Trial ID:** [NCT07695233](https://clinicaltrials.gov/study/NCT07695233) ## Key Facts - **Phase:** NA - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Robert Chen - **Target Enrollment:** 50 participants - **Start Date:** 2024-05-17 - **Completion Date:** 2027-12 - **Conditions:** Parkinson Disease, Freezing of Gait Symptoms in Parkinson Disease - **Interventions:** Excitatory Stimulation, Inhibitory Stimulation, Sham - **Intervention Types:** DEVICE ## Summary For Families Researchers are testing whether stimulating a small brain area called the pedunculopontine nucleus, which helps control voluntary movement, walking, and muscle tone, can reduce freezing of gait in people with Parkinson's. They use focused ultrasound through the skull to target that area, giving sessions that are excitatory, inhibitory, or sham, and they will measure patient-reported changes, detailed gait analysis, and brain scans before and after to look at changes in how the area connects with the rest of the brain and in blood flow. The study is enrolling adults 18 to 90 who have Parkinson's with freezing of gait and a stable Parkinson's medication dose for at least four weeks; people with prior brain surgery or implanted devices, stroke or seizure history, diagnosed dementia, pregnancy, certain psychiatric conditions or use of antipsychotics or recreational drugs, or incompatible metal implants are not eligible. ## What This Actually Involves **Placebo** _(Ask the coordinator)_: This trial's group design isn't clear enough in the registry data to rule out a placebo or sham. Ask the coordinator whether there is a placebo group and what your chance of being assigned to it would be. **Visits** _(From the protocol)_: PD patients have Visit 1 and Visits 2-4, with Visits 2-4 spaced at least a week apart. > "Visit 1: Obtain anatomical MRI for TUS planning and rsfMRI for functional connectivity analysis in PD patients with FOG. This session also includes baseline clinical evaluation, kinematic gait analysis in the ON-medication state. Between Visits 1 and 2: Structural MRI data of each participant will be processed using BabelBrain software to configure the TUS parameters. The depth required to stimulate the PPN will be calculated, and a precise model of the pressure distribution and thermal dynamics of the TUS based on individual skull thickness and geometry will be created. Visits 2-4: The TUS will be applied using a 4-element NeuroFUS LT system (BrainBox Neuro Ltd., UK). This system allows for adjustments of the focus point of the ultrasound, which in essence changes the stimulation depth. Participants receive excitatory, inhibitory, or sham TUS for three sets of sonication, targeting the PPN bilaterally, with each stimulation set separated by one hour (accelerated TUS). We will be using excitatory and inhibitory protocols since DBS has complex excitatory and inhibitory effects and it is not known whether excitatory or inhibitory protocols will be most effective. The type of sonication (excitatory, inhibitory, or sham) will be the same within a visit but different across visits. The visits will be spaced at least a week apart to allow for a washout period." **Procedures** _(From the protocol)_: - Ultrasound (Non-invasive) > "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." - MRI scan (Non-invasive) > "The study will also investigate the effects of the stimulation on the PPN and surrounding connectivity by using magnetic resonance imaging (MRI)." - Walking & movement tests (Non-invasive) > "This session also includes baseline clinical evaluation, kinematic gait analysis in the ON-medication state." **Washout** _(From the protocol)_: The visits will be spaced at least a week apart to allow for a washout period. > "The visits will be spaced at least a week apart to allow for a washout period." **Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered. _Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._ ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 90 Years - **Sex:** ALL ### Full Criteria ``` 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 ``` ## Locations (1) - Toronto Western Hospital, Toronto, Ontario, Canada _(43.7064, -79.3986)_ - Julian Kwok, (CONTACT), 416-603-5800, julian.kwok@uhn.ca - Robert Chen, MD, (PRINCIPAL_INVESTIGATOR) ## Central Contacts - Julian Kwok, (CONTACT), 416-603-5800, julian.kwok@uhn.ca --- *Canonical: https://parkinsonspathways.com/trial/NCT07695233* *HTML version: https://parkinsonspathways.com/trial/NCT07695233* *Source data: https://clinicaltrials.gov/study/NCT07695233*