Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT03900247
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-18
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-04-01
• Last Update Submitted: 2019-04-01
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Action Research Armtest part b Grip	At 6 months	performance with and without BCI/robotic device

Secondary Outcome Measures

Name	Time	Method
Grip strength	At 6 months	Hand held dynamometer with and without BCI/robotic device
Bringing glass of water to the mouth	At 6 months	Ability to bring a glass of water to the mouth with and without BCI/robotic device

Trial Locations

Locations (1)

Center of Functionally Integrative Neuroscience; 🇩🇰 Aarhus, Denmark