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Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface (REMAP)

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ClinicalTrials.gov Identifier: NCT03900247
Recruitment Status : Enrolling by invitation
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborators:
University of Aalborg, Denmark
The Danish National Rehabilitation Center for Neuromuscular Diseases
Bioservo Technologies AB, Sweden
Department of Neurology, Aarhus University Hospital, Denmark
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Device: REMAP EEG based BCI and SEM-Glove BioServo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Action Research Armtest part b Grip [ Time Frame: At 6 months ]
    performance with and without BCI/robotic device


Secondary Outcome Measures :
  1. Grip strength [ Time Frame: At 6 months ]
    Hand held dynamometer with and without BCI/robotic device

  2. Bringing glass of water to the mouth [ Time Frame: At 6 months ]
    Ability to bring a glass of water to the mouth with and without BCI/robotic device



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900247


Locations
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Denmark
Center of Functionally Integrative Neuroscience
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
University of Aalborg, Denmark
The Danish National Rehabilitation Center for Neuromuscular Diseases
Bioservo Technologies AB, Sweden
Department of Neurology, Aarhus University Hospital, Denmark

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03900247     History of Changes
Other Study ID Numbers: 6153-00010A
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
brain computer interface
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases