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

Conditions

• Parkinson's Disease With Freezing of Gait

Eligibility Criteria

Sex

ALL

Age

60 Years - 90 Years

Healthy Volunteers

Not accepted

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.

Study Details

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

Key Dates

Start date

Oct 31, 2026

Status verified

Jun 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: First mode of cueStim
  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.
• Active Comparator: Second mode of cueStim
  The second, unidentified mode is a modified version of the cueStim stimulator which uses a different mode of stimulation.

Primary Outcome Measure

Demonstrate Superiority [ Time Frame: From enrollment to the end of treatment at 4 weeks ]

Locations (6)

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