- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02358915
A Two-step Training Paradigm for Voluntary Control of the Peri-auricular Muscles
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- Première phase 1
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90089
- University of Southern California-Health Sciences Campus
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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.
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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The surface EMG signal amplitude of the auricular muscles at the maximum voluntary contraction
Délai: Up to 5 weeks
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Up to 5 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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The computer game performance score
Délai: Up to 2 weeks
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Up to 2 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Carolee J. Winstein, Ph.D, University of Southern California
- Chercheur principal: Baker Lucinda, Ph.D, University of Southern California
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HS-14-00672
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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