Validation of cueStim for Reduction of Freezing of Gait in Parkinson's Disease

Fortis Medical Devices Limited

Status: Begins enrollment in 2 months

Conditions: Parkinson's Disease With Freezing of Gait

Treatments: Device: CueStim

Study type: Interventional

Funder types: Industry

Identifiers

NCT07675408

cueStim-PD

Details and patient eligibility

About

The goal of this clinical trial is to learn if the cueStim device can reduce the duration of freezing of gait (FoG) that occurs in patients with Parkinson's Disease. The study will compare two modes of operation of the cueStim device; both modes of operation use the same wearable device. The purpose of the study is to compare how the two modes affect symptoms across study participants. Because this is a research study, it is not yet known whether either mode reduces symptoms.

Participants will:

• Be randomized to one of the two modes available on the cueStim device
• Wear the device for 4 weeks as they go about their daily life
• Complete daily diary entries to document symptoms, falls and overall experience
• Check-in with the clinical site throughout participation
• Complete a final follow-up visit

Full description

This is a prospective, randomized, double-blind, parallel group, multicenter, pivotal clinical trial to validate the use of cueStim for reduction of duration of FoG in Parkinson's patients.

Enrolled subjects will be randomized 1:1 to two different modes of treatment. All subjects will be blinded to the study hypothesis. The clinician will not be blinded; however, specialists who will evaluate the outcome will be blinded. Enrolled subjects will be provided with training on the device during a clinic visit, and phone support is available throughout the home treatment duration.

Study procedures / visits consists of:

• In-clinic Screening visit to ensure eligibility
• Baseline visit for device setup and training (may be combined with screening visit)
• "Home" (unsupervised at and out of the home) use of the device for four (4) weeks) as the patient goes about their daily life
• End-of-treatment Follow-up visit

The primary objective of this clinical investigation is to determine if one mode of treatment demonstrates superiority after four weeks of device use, in reducing the duration of FoG, while the device is being worn by patients with PD receiving medication.

Enrollment: 60 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age 60-90 years, inclusive
• Diagnosis of idiopathic PD, confirmed by a neurologist/Medical Doctor (MD), medical records, and verified during a post consent in-clinic evaluation by a trained MD
• Patients can walk 12 meters without a walking aid (cane permitted during daily life)
• The patient is using levodopa treatment. PD medications are stable, with no changes in PD-related medications for at least four weeks prior to screening visit, and stable dosing expected for duration of the study
• Score greater or equal to 22 on the Montreal Cognitive Assessment (MoCA)
• Satisfactory standard neurological examination, including completion of MDS- UPDRS I, II, III and IV by study clinician
• PTF ≥20% during the baseline in-clinic FoG Provocation Test (conducted without the device) as determined by the centralized blinded video analysis using the FoG Switch tool by trained personnel independent of site investigators.

Exclusion Criteria

• Atypical or secondary parkinsonism, including vascular parkinsonism
• History of dementia, severe depression, psychosis, or active hallucinations
• History of migraines, tinnitus, seizures or sensory issues
• Other neurological or orthopedic impairment significantly affecting gait
• Previous use of cueing devices within the last 3 months
• Use of implanted electronic devices, including deep brain stimulation (DBS)
• Use of assistive devices incompatible with the device (DBS users will be excluded
• Is participating in another clinical trial during the study period
• Any condition that, in the investigator's opinion, makes the participant unsuitable
• As per medical records, any of the following identified within 3 months: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft, percutaneous coronary intervention, implantation or use of a cardiac resynchronization therapy device, active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse.
• Pregnant or breastfeeding women

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

First mode of cueStim

Active Comparator group

Description:

The first, unidentified mode delivers electrical stimulation to the legs to improve gait (i.e., reduce Freezing of Gait \[FoG\]) of patients with Parkinson's disease (PD). There are also 2 electrodes which connect the stimulators to the subject. Stimulators are attached to the thigh of each leg. The stimulators deliver sensory electrical stimulation (sES), a non-adaptive rhythmic cueing strategy consisting of a continuous series of biphasic electrical stimulation bursts, in an alternating rhythmic manner scaled to the patient's stride rate. Stimulation is customized to each patient prior to first-time use via a Clinician Tablet Controller. The Tablet Controller is used to program and to adjust device stimulation settings over time. The Stimulators' on-board electronics sense when the patient is sitting, has stopped walking or is attempting to walk and delivers stimulation only when the patient is actively walking or attempting to walk.

Treatment:

Device: CueStim

Second mode of cueStim

Active Comparator group

Description:

The second, unidentified mode is a modified version of the cueStim stimulator which uses a different mode of stimulation.

Treatment:

Device: CueStim