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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will compare two modes of operation of the cueStim device; both modes of operation use the same wearable device."
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the wearable cueStim device can shorten freezing of gait, when a person gets stuck while trying to walk. It is for adults ages 60–90 with Parkinson’s disease. Participants will use one of two device modes for 4 weeks; researchers do not yet know if either mode helps.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 60–90 years old.
  • Have Parkinson’s disease with no known cause, confirmed by doctors, medical records, and a study exam.
  • Be able to walk 12 meters (about 39 feet) without a walking aid. A cane is allowed in daily life.
  • Take levodopa for Parkinson’s. Parkinson’s medicines must be unchanged for at least 4 weeks before screening, with no dose changes expected during the study.
  • Score at least 22 on the MoCA, a test of memory and thinking.
  • Have a satisfactory exam of the brain and nerves, including the study’s Parkinson’s symptom checks.
  • Have freezing of gait during at least 20% of the first clinic walking test, done without the device and checked by independent video reviewers.

Who can't join

  • Have another type of parkinsonism, a condition with symptoms like Parkinson’s, or another brain, nerve, bone, or joint problem that greatly affects walking.
  • Have a history of dementia, severe depression, psychosis (trouble knowing what is real), or current hallucinations (seeing or hearing things that are not there).
  • Have a history of migraines, ringing in the ears, seizures, or problems with the senses.
  • Have used a cueing device to help walking in the past 3 months, have an implanted electronic device such as deep brain stimulation, or use an aid that cannot work with cueStim.
  • Be in another clinical trial during this study, or have any condition the study doctor thinks makes participation unsuitable.
  • Have records showing any of these in the past 3 months: heart attack, hospital stay for unstable chest pain, stroke, heart bypass surgery, a procedure to open heart arteries, placement or use of a device to coordinate heartbeats, or severe uncontrolled heart failure.
  • Have records showing active cancer treatment, acute psychosis, a major mental health disorder, or ongoing substance abuse in the past 3 months.
  • Be pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (6)

FL

GA

KS

OR

WA