A Two-step Training Paradigm for Voluntary Control of the Peri-auricular Muscles

The current study intends to test the effectiveness of a two-step training paradigm for a set of skeletal muscles, which are above and behind the external portion of the ear (Peri-auricular muscles).

Study Overview

• Status: Completed
• Conditions: Non-disabled Volunteers; Lacking Voluntary Control of Ear Muscles
• Intervention / Treatment: Device: FastStart neuromuscular electrical stimulator

Detailed Description

Survivors of spinal cord injury (SCI) usually have severe mobility limitation due to their paralysis.In order to improve the independence of living for those patients, scientists and engineers invented many different types of assistive devices, such as breath controlled "sip and puff" devices, speech controlled devices, eye movement controlled devices, and head movement controlled devices. However, one limitation of the previous designs is that they all require usurping the intact function of a functional organ like mouth or eyes. A recent design by Reach Bionic's company takes advantage of a set of ear muscles-the peri-auricular muscles-that are present in more than 95% of the population, but do not serve any physiologic function in humans. These muscles are innervated by branches of cranial nerves that are controlled through the brain stem, above the spinal cord. Therefore, it is unlikely they will be affected even by a very high SCI. The design intention is to translate the ear contraction signal from the muscles into the meaningful control signal to direct a wheelchair or operate a computer cursor in a fashion to a joystick or mouse. However, since most people do not have the ability to voluntarily contract their ear muscles, the question remains how to best learn to contract our ear muscles and design an effective training paradigm.

Since norm volunteers will have the same voluntary control of their peri-auricular muscles as the patients suffering from spinal cord injury, thus, the investigators are going to test the effectiveness of our two-step training paradigm among the healthy participants at this explorative stage.

In specific, at the first step of training, participants will be asked to voluntarily contract their ear muscles with the facilitation of electrical stimulation. At the second step of training, they will take part in a computer game and will be asked to move a cursor to a specific target that will randomly appear on the computer screen. The cursor will be controlled by the electrical activities produced by the ear muscles contractions that will be captured by surface electromyography (EMG) signals.

The computer game performance of each participant before and after the second step of training with surface EMG signals feedback and the mean surface EMG signal amplitude of the auricular muscles at the maximum voluntary contraction at baseline, after the first step of training, and after the second step of training will be compared.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • University of Southern California-Health Sciences Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy participants
• can't control their peri-auricular muscles at the beginning of the study (no visible movement of the ears on command).

Exclusion Criteria:

• Suffering any comorbid neuromuscular disease.
• Having a history of severe traumatic brain injury.
• Demonstrating cognitive impairment that would prevent them from providing inform consent or following the directions of the study protocol.
• Having a history of migraine headaches that could be exacerbated with the use of the electrical stimulation or the prolonged training sessions.
• Temporomandibular Joint (TMJ) dysfunction that could lead to unusual discomfort following training session.
• Having a history of prior seizure.
• Being implanted with pacemaker or defibrillators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Peri-auricular muscles voluntary contraction training paradigm; The whole training paradigm consists of two steps. At the first step of training, the electrical stimulation (FastStart neuromuscular electrical stimulator) will be applied to facilitate the voluntary contractions of the ear muscles, and the motion of the outer ear in two directions (up/down, forward/backward) will be videotaped and played back to the participants so that they can get real-time visual feedback about their ear movement. At the second step of training, surface EMG electrodes will be placed on the skin around participants' ears. During the training, they are required to move a cursor to a specific target that will randomly appear on the computer screen. The cursor will be controlled by the electrical signal from the contraction of their bilateral peri-auricular muscles. In the computer game, contraction of the left ear muscles will move the cursor to the left side and contraction of your right ear muscles will move the cursor to the right side.

Device: FastStart neuromuscular electrical stimulator; Other Names: Biosemi Active two EMG measurement system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The surface EMG signal amplitude of the auricular muscles at the maximum voluntary contraction	Up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The computer game performance score	Up to 2 weeks

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Carolee J. Winstein, Ph.D, University of Southern California; Principal Investigator: Baker Lucinda, Ph.D, University of Southern California

Publications and helpful links

General Publications

• Chanthaphun S, Heck SL, Winstein CJ, Baker L. Development of a training paradigm for voluntary control of the peri-auricular muscles: a feasibility study. J Neuroeng Rehabil. 2019 Jun 14;16(1):75. doi: 10.1186/s12984-019-0540-x.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 9, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HS-14-00672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED