Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2022-12-31

Brief Summary

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The current project will aid patients with motor impairment to reduce the need for homecare. Specifically the aim is to develop and implement a robotic exoskeleton and brain computer interface to assist and eventually perform arm and hand movement in patients with the progressive neurodegenerative disease ALS. This proposal brings together state-of-the-art robotic technology, EEG-based brain computer interface (BCI) know-how, clinical expertise, patient perspective and industrial partners to develop and implement a robotic arm/hand device that will adapt, with increasing brain-computer control, based on the need of the patient. In short the BCI will measure electroencephalography (EEG) from the surface of the scalp and recognize signature EEG as the patient intents to move. As the patient loses muscle power the BCI robotic-device will gradually take over and support motor activity, even when the patient is totally paralyzed. As the device supports hand/arm function only, the investigators aim to address ADLs associated to hand function, specifically eating activities.

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Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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REMAP EEG based BCI and SEM-Glove BioServo

EEG-based brain computer interface (BCI) will be adapted to individual ALS patients and modified to control external robotic devices

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ALS according to the latest revision of El Escorial Criteria (Ludorph et al. 2015)
* Loss of muscle force or fine motor skills in a hand

Exclusion Criteria

* Other severe Neurological or Psychiatric disease
* Drug or Alcohol dependency
* Pregnancy
* Severe cognitive disturbances found to impede with study completion

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No