Wearable Garment vs Gel Electrodes for Electrical Muscle Stimulation

ConditionHealthy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMyant Medical Corp.

About this trial

The goal of this study is to evaluate whether textile-based electrodes can provide neurostimulation that is comparable in comfort and effectiveness to traditional hydrogel electrodes in healthy adults.

The main questions it aims to answer are:

1. Is the perceived sensation of stimulation using textile electrodes non-inferior to that of hydrogel electrodes? 2. Is the current required to evoke muscle contractions similar between textile and hydrogel electrodes?

Each participant will complete three stimulation conditions in random order across separate visits:

1. hydrogel electrodes (standard), 2. dry polymer-textile electrodes with lotion, and 3. dry textile electrodes with hydrogel pads

Electrical stimulation will be delivered to the lower leg muscles using a wearable sleeve with integrated electrodes. The investigators will assess sensorimotor thresholds (e.g., detection, motor, and full motor threshold), skin-electrode impedance, and torque. Participants will also rate stimulation comfort, intensity, and sensation location via questionnaire.

After the three primary arms, participants may optionally complete two additional arms using different moisturizers applied to the textile electrodes to evaluate their impact on stimulation performance.

The results of this study will help determine whether textile electrodes can be used as an effective and comfortable alternative to hydrogel electrodes in wearable neurostimulation applications.

Eligibility criteria

Qualifiers

Healthy (without a known diagnosis of cardiovascular, pulmonary or neurological condition)

Disqualifiers

Known pregnancy

Implanted defibrillator or pacemaker

Pain in the body part being tested

Open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the electrodes

Trial design

Treatments tested in this trial

  • Hydrogel electrodes
  • Dry polymer-textile electrodes with Skin Lotion A
  • Dry textile electrodes with gel pads attached to the electrode
  • Dry polymer-textile electrodes with Skin Lotion B
  • Dry polymer-textile electrodes with Skin Lotion C

Treatment groups

20 Participants
are divided into 5 treatment groups

Sponsors and collaborators