Wearable Garment vs Gel Electrodes for Electrical Muscle Stimulation

NCT07050784 | Not Yet Recruiting

• 1 other identifier: 157491
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is the perceived sensation of stimulation using textile electrodes non-inferior to that of hydrogel electrodes?
2. 2.Is the current required to evoke muscle contractions similar between textile and hydrogel electrodes?
3. 3.hydrogel electrodes (standard),
4. 4.dry polymer-textile electrodes with lotion, and
5. 5.dry textile electrodes with hydrogel pads

Conditions

Healthy

Keywords

Textile electrodes; Smart clothing; Neuromuscular electrical stimulation; Transcutaneous electrical nerve stimulation; Functional electrical stimulation

Outcome Measures

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.

  At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.

Secondary Outcomes (5)

• Sensorimotor responses to electrical stimulation

  At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.

• Kinematic recruitment curves

  At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.

• Torque

  At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.

• Sensation questionnaire

  At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.

• Skin-electrode impedance

  At each of the 5 study visits (Visit 1 through Visit 5) over approximately a 3-week period.

Study Arms (5)

Hydrogel electrodes

ACTIVE COMPARATOR

Gold-standard comparator

Device: Hydrogel electrodes

Dry polymer-textile electrodes with Skin Lotion A

EXPERIMENTAL

Device: Dry polymer-textile electrodes with Skin Lotion A

Dry textile electrodes with gel pads attached to the electrode

EXPERIMENTAL

Device: Dry textile electrodes with gel pads attached to the electrode

Dry polymer-textile electrodes with Skin Lotion B

EXPERIMENTAL

Device: Dry polymer-textile electrodes with Skin Lotion B

Dry polymer-textile electrodes with Skin Lotion C

EXPERIMENTAL

Device: Dry polymer-textile electrodes with Skin Lotion C

Interventions

Hydrogel electrodes DEVICE

Neurostimulation using standard self-adhesive hydrogel electrodes

Hydrogel electrodes

Dry polymer-textile electrodes with Skin Lotion A DEVICE

Neurostimulation with dry polymer-textile electrodes using Skin Lotion A

Dry polymer-textile electrodes with Skin Lotion A

Dry textile electrodes with gel pads attached to the electrode DEVICE

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

Dry textile electrodes with gel pads attached to the electrode

Dry polymer-textile electrodes with Skin Lotion B DEVICE

Neurostimulation with dry polymer-textile electrodes with Skin Lotion B

Dry polymer-textile electrodes with Skin Lotion B

Dry polymer-textile electrodes with Skin Lotion C DEVICE

Neurostimulation with dry polymer-textile electrodes using Skin Lotion C

Dry polymer-textile electrodes with Skin Lotion C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Severe frailty such that donning or doffing the garment may cause a danger of falling

Sponsors & Collaborators

• Myant Medical Corp.: lead

Study Sites (1)

Myant Medical Corp

Mississauga, Ontario, L5K 2L1, Canada

Location

Study Officials

• Milad Alizadeh Meghrazi

  Myant Medical Corp.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amirali Toossi

CONTACT

4164237906; amirali.toossi@myant.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover randomized controlled trial

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 3, 2025
• Study Start: July 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)