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

NCT07675408 | Not Yet Recruiting

• 1 other identifier: cueStim-PD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Parkinson's Disease With Freezing of Gait

Keywords

Parkinson's Disease; Freezing of Gait

Outcome Measures

Primary Outcomes (1)

• Demonstrate Superiority

  The main goal of this study is to determine whether one mode of the cueStim device works better than another. After four weeks of use, it will be compared how well each mode reduces the duration of freezing of gait in patients with Parkinson's Disease who are taking medication, while they are wearing the device.

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

First mode of cueStim

ACTIVE COMPARATOR

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.

Device: CueStim

Second mode of cueStim

ACTIVE COMPARATOR

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

Device: CueStim

Interventions

CueStim DEVICE

Enrolled patients will be assigned to one of two modes and will be blinded to their assignment. The Device will be worn for four weeks throughout the patient's daily life. The patient will complete daily diary entries, periodically check in with the clinical staff, and complete questionnaires related to the impact of freezing of gait and Parkinson's Disease on daily life and function.

First mode of cueStim; Second mode of cueStim

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fortis Medical Devices Limited: lead
• Avania: collaborator

Study Sites (6)

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Arrow Clinical Trials

Daytona Beach, Florida, 32117, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Evergreen Health Research Program

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 30, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)