Wearable Garment vs Gel Electrodes for Electrical Muscle Stimulation

Condition(s) studied

Investigational drug(s) / intervention(s)

Hydrogel electrodes: Neurostimulation using standard self-adhesive hydrogel electrodes

Dry polymer-textile electrodes with Skin Lotion A: Neurostimulation with dry polymer-textile electrodes using Skin Lotion A

Dry textile electrodes with gel pads attached to the electrode: Neurostimulation with dry textile electrodes with gel pads attached to the electrode

Dry polymer-textile electrodes with Skin Lotion B: Neurostimulation with dry polymer-textile electrodes with Skin Lotion B

Dry polymer-textile electrodes with Skin Lotion C: Neurostimulation with dry polymer-textile electrodes using Skin Lotion C

Study summary

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

Primary outcome measure(s)

• Perceived intensity of stimulation — At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.
  Participants will rate the perceived intensity of electrical stimulation at the current required to elicit 20% of their maximal voluntary contraction (MVC). Intensity will be assessed using a 10-point numerical scale, where 0 represents no sensation and 10 represents painful stimulation.

Trial sites (1)

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