Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy

Official title

Randomized, Sham-Controlled, Multicenter Investigation of the Leia Sensory Prosthesis on Gait and Balance in Peripheral Neuropathy.

Overview

This study will evaluate a wearable device intended to support balance and gait in adults with peripheral neuropathy. Participants will use the device for a defined period, and outcomes related to safety, usability, and functional performance will be assessed.

Detailed description

This clinical investigation will assess a non-invasive wearable device designed to enhance gait and balance in individuals with peripheral neuropathy. The study will evaluate whether the device can improve balance and gait stability during daily activities, and will also examine safety, comfort, and overall user acceptability over the study period.

Interventions

• Device Active wearable device
  A non-invasive wearable device used to assess balance, gait, and usability in individuals with peripheral neuropathy.
• Device Sham wearable device
  A sham version of the wearable device without active functionality.

Primary outcome measures

• Functional Gait Assessment (FGA) total score [Time frame: Change in Functional Gait Assessment (FGA) total score from baseline (day 0) to day 56.]

Secondary outcome measures (12)

• Functional Gait Assessment (FGA) total score [Time frame: From baseline (day 0) to the end of the supervised period (day 28), change from day 28 to day 56, and evaluation of evolution across all timepoints, with and without stimulation]
• Timed-up and Go (TUG) in seconds [Time frame: Change from Baseline to day 56]
• Neuropathic pain symptoms (NPSI questionnaire) [Time frame: Change from baseline to each of the follow-up time points (day 7, 14, 28, 35, 42, 49, 56 and 80)]
• Quality of life (NORFOLK QOL-DN, EQ-5D-5L questionnaire) [Time frame: Change from baseline to day 28, day 56 and day 80]
• Sensory function - Monofilament test [Time frame: Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28 and 56)]
• Sensory function - Rydel-Seiffer tuning fork test [Time frame: Change from baseline value from day 7 pre-stimulation to follow-up time points (day 28, and 56)]
• Sensory function - Sudoscan (subset of patients) [Time frame: Change from baseline to day 56]
• Impact on fall risk: fall questionnaire [Time frame: Change from baseline to day 28, day 56 and day 80]
• Neuroimaging (MRI) (subset of patients) [Time frame: Change from baseline to day 56]
• Treatment compliance [Time frame: Through home use phase of 4 weeks]
• Objective gait parameters (Movement Lab): step length in cm [Time frame: Baseline, day 28 and day 56]
• Objective gait parameters (Movement Lab): step width in cm [Time frame: Baseline, day 28 and day 56]

Eligibility criteria

Inclusion criteria

• Signed informed consent prior to any study procedure
• Adults ≥ 18 years
• Clinical diagnosis of peripheral neuropathy, confirmed per site procedures and neurophysiological testing (e.g. NCV)
• Gait or balance difficulties as self-reported and confirmed by Functional Gait Assessment (FGA score ≤ 23) and/or single-leg stance < 30 seconds
• Able to walk without walking aids
• Stable supplements and medications ≥ 1 month before baseline and willing to maintain stability during the investigation (same dosage and same medication within the last month)
• Willingness and ability to attend weekly sessions, perform home use, and return for follow-up

Exclusion criteria

• Untreated/unhealed lesion of any kind (e.g., wounds, swelling, infection, inflamed area of skin or eruptions on the lower leg (foot and ankle) or near product use (e.g., untreated lymphedema, phlebitis, thrombo-phlebitis or varicose veins)
• Untreated/unhealed fractures in the foot and ankle
• Cancerous growth in the planned treatment area
• Severe peripheral vascular disease (e.g., gangrene)
• Cognitive impairment that precludes informed consent or device use
• Implanted electrical devices or pacemakers
• Lower-limb orthoses/braces that cannot be removed for assessments
• Pregnant or breast-feeding females
• Usage of other medical devices for the relief of neuropathic symptoms during the study
• Current participation in any other clinical study using an investigational device or investigational drug
• Orthopedic conditions substantially limiting gait (e.g., failed back surgery syndrome (FBSS), recent hip or knee replacement, unstable fractures) as judged by the investigator
• For patients who have been randomized in the active treatment group only: Incapability to perceive somatotopic sensations (tested at screening by MYNERVA staff)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Switzerland · 3 centers

• Hôpital de la Tour — Meyrin
• Ensemble Hospitalier de la Côte (EHC) — Morges
• Universitätsklinik Balgrist — Zurich

Publications

• Gozzi N, Chee L, Odermatt I, Kikkert S, Preatoni G, Valle G, Pfender N, Beuschlein F, Wenderoth N, Zipser C, Raspopovic S. Wearable non-invasive neuroprosthesis for targeted sensory restoration in neuropathy. Nat Commun. 2024 Dec 30;15(1):10840. doi: 10.1038/s41467-024-55152-7. PMID 39738088

Identifiers

NCT: NCT07236515 · MYN-L001-001 · Unique Device Identifiers

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗