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

2026년 6월 26일 업데이트: Fortis Medical Devices Limited

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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Florida
      • Boca Raton, Florida, 미국, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
        • 수석 연구원:
          • Stuart Isaacson, MD
        • 연락하다:
      • Daytona Beach, Florida, 미국, 32117
        • Arrow Clinical Trials
        • 수석 연구원:
          • David Billmeier, MD
        • 연락하다:
    • Georgia
      • Atlanta, Georgia, 미국, 30329
        • Emory University
        • 연락하다:
        • 수석 연구원:
          • Lucas McKay, PhD MSCR
    • Kansas
      • Kansas City, Kansas, 미국, 66160
        • University of Kansas
        • 연락하다:
        • 수석 연구원:
          • Kelvin Au, MD, FRCPC
    • Oregon
      • Portland, Oregon, 미국, 97239
        • Oregon Health and Science University
        • 수석 연구원:
          • Martina Mancini, PhD
        • 연락하다:
    • Washington
      • Kirkland, Washington, 미국, 98034

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
장치: CueStim
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.
활성 비교기: Second mode of cueStim
The second, unidentified mode is a modified version of the cueStim stimulator which uses a different mode of stimulation.
장치: CueStim
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Demonstrate Superiority
기간: From enrollment to the end of treatment at 4 weeks
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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fortis Medical Devices Limited

협력자

Avania

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 1일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2026년 6월 18일

QC 기준을 충족하는 최초 제출

2026년 6월 26일

처음 게시됨 (실제)

2026년 6월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 26일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • cueStim-PD

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다