Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

Study Purpose:

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.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Device

Intervention Name:

REMAP EEG based BCI and SEM-Glove BioServo

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

N/A

Clinicaltrials.gov ID:

NCT03900247

Neals Affiliated?

No

Coordinating Center Contact Information

Study Sponsor:

University of Aarhus

Estimated Enrollment:

15

Estimated Study Start Date:

03 / 18 / 2019

Estimated Study Completion Date:

12 / 31 / 2022

Posting Last Modified Date:

04 / 02 / 2019

Date Study Added to neals.org:

04 / 02 / 2019

Minimum Age:

18 Years

Maximum Age:

90 Years

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

Center of Functionally Integrative Neuroscience

Aarhus 8000
Denmark