Parkinson's Disease With Freezing of GaitNCT07675408
Validation of cueStim for Reduction of Freezing of Gait in Parkinson's Disease
A study testing CueStim in people with Parkinson's Disease With Freezing of Gait, run by Fortis Medical Devices Limited at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Parkinson's Disease With Freezing of Gait
- What is being tested?
- CueStim
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2026to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30329
Lucas McKay, PhD MSCR, 404-550-5157, j.lucas.mckay@emory.edu
Lucas McKay, PhD MSCR
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Research Coordinator, 561-392-1818 ext. 2, info@ParkinsonsCenter.org
Stuart Isaacson, MD
Arrow Clinical Trials
Daytona Beach, Florida, 32117
Lexi Bancroft, (386) 278-8000 ext. 0307, ABancroft@arrowtrials.com
David Billmeier, MD
University of Kansas
Kansas City, Kansas, 66160
Kelly Lyons, PhD, 913-588-7159, klyons@kumc.edu
Kelvin Au, MD, FRCPC
Evergreen Health Research Program
Kirkland, Washington, 98034
Evergreen Health, 425-899-5385, evergreenresearch@evergreenhealthcare.org
Pinky Agarwal, MD, FAAN
Oregon Health and Science University
Portland, Oregon, 97239
Graham Harker, MPH, (503) 418-2601, balance@ohsu.edu
Martina Mancini, PhD
About this study
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
Read the detailed 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.
- Being tested
- CueStim
- Keywords
- Parkinson's Disease, Freezing of Gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CueStimDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: CueStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease With Freezing of GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fortis Medical Devices Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675408
- Sponsor's protocol ID
- cueStim-PD
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No