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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Hydrogel electrodes
DeviceNeurostimulation using standard self-adhesive hydrogel electrodes
Dry polymer-textile electrodes with Skin Lotion A
DeviceNeurostimulation with dry polymer-textile electrodes using Skin Lotion A
Dry textile electrodes with gel pads attached to the electrode
DeviceNeurostimulation with dry textile electrodes with gel pads attached to the electrode
Dry polymer-textile electrodes with Skin Lotion B
DeviceNeurostimulation with dry polymer-textile electrodes with Skin Lotion B
Dry polymer-textile electrodes with Skin Lotion C
DeviceNeurostimulation with dry polymer-textile electrodes using Skin Lotion C
Treatment groups
20 Participants
are divided into 5 treatment groupsGroup A: Hydrogel electrodesActive comparator 1 intervention
Group B: Dry polymer-textile electrodes with Skin Lotion AExperimental treatment 1 intervention
Group C: Dry textile electrodes with gel pads attached to the electrodeExperimental treatment 1 intervention
Group D: Dry polymer-textile electrodes with Skin Lotion BExperimental treatment 1 intervention
Group E: Dry polymer-textile electrodes with Skin Lotion CExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Perceived intensity of stimulation
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.
Time frame
At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.Secondary outcomes
1
Sensorimotor responses to electrical stimulation
Current amplitude required to elicit various sensorimotor responses will be recorded. Participants will receive electrical stimulation to the lower leg. The study will measure: * Detection threshold: the smallest current the participant can feel. * Motion threshold: the lowest current that causes visible movement. * Full range of motion amplitude: the current needed for full joint range of motion. * Just noticeable difference: the smallest change in current a participant can detect. Stimulation will be increased gradually and stopped if discomfort is reported. All stimulation will not exceed safe current limits (i.e., 100 mA).
Time frame
At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.2
Kinematic recruitment curves
Kinematic recruitment curves will be created by measuring ankle movement during stimulation. A camera will record the ankle as stimulation amplitude increases in small increments. Joint angles will be measured from the video and plotted against stimulation intensity to produce kinematic recruitment curves.
Time frame
At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.3
Torque
Maximum voluntary contraction (MVC) will be determined through three maximal effort contractions of the ankle. Electrical stimulation will then be applied to determine the current required to produce 20% of the MVC.
Time frame
At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.4
Sensation questionnaire
Participants will complete a questionnaire following stimulation to report: * How the stimulation felt * Where it was felt * How comfortable it was, rated on a 7-point scale, with 0 being comfortable and 7 being uncomfortable
Time frame
At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: