Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

NCT03900247 | Unknown

• 1 other identifier: 6153-00010A
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

brain computer interface

Outcome Measures

Primary Outcomes (1)

• Action Research Armtest part b Grip

  performance with and without BCI/robotic device

  At 6 months

Secondary Outcomes (2)

• Grip strength

  At 6 months

• Bringing glass of water to the mouth

  At 6 months

Interventions

REMAP EEG based BCI and SEM-Glove BioServo DEVICE

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aalborg University: collaborator
• The Danish National Rehabilitation Center for Neuromuscular Diseases: collaborator
• Bioservo Technologies AB, Sweden: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Center of Functionally Integrative Neuroscience

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: April 2, 2019
• Study Start: March 18, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: April 2, 2019

Record last verified: 2019-03

Locations

DK (1)