Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

Study Overview
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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.

Official Title
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Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Device: REMAP EEG based BCI and SEM-Glove BioServo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: 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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Armtest part b Grip | performance with and without BCI/robotic device | At 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Hand held dynamometer with and without BCI/robotic device | At 6 months | 
| Bringing glass of water to the mouth | Ability to bring a glass of water to the mouth with and without BCI/robotic device | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain computer interface