Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

26 juni 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Apparaat: 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.
Actieve vergelijker: Second mode of cueStim
The second, unidentified mode is a modified version of the cueStim stimulator which uses a different mode of stimulation.
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Demonstrate Superiority
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fortis Medical Devices Limited

Medewerkers

Avania

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 februari 2027

Studieregistratiedata

Eerst ingediend

18 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

30 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

26 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • cueStim-PD

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren