Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

Amyotrophic Lateral Sclerosis Clinical Trial

— REMAP  

Official title:

Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03900247
• Other study ID #: 6153-00010A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

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

Locations

Country	Name	City	State
Denmark	Center of Functionally Integrative Neuroscience	Aarhus

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Bioservo Technologies AB, Sweden, Department of Neurology, Aarhus University Hospital, Denmark, The Danish National Rehabilitation Center for Neuromuscular Diseases, University of Aalborg, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Armtest part b Grip	performance with and without BCI/robotic device	At 6 months
Secondary	Grip strength	Hand held dynamometer with and without BCI/robotic device	At 6 months
Secondary	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