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

26 giugno 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Dispositivo: 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.
Comparatore attivo: Second mode of cueStim
The second, unidentified mode is a modified version of the cueStim stimulator which uses a different mode of stimulation.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Demonstrate Superiority
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fortis Medical Devices Limited

Collaboratori

Avania

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

1 febbraio 2027

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • cueStim-PD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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