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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
REMAP EEG based BCI and SEM-Glove BioServo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Amyotrophic Lateral Sclerosis focused on measuring brain computer interface

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center of Functionally Integrative Neuroscience

Outcomes

Primary Outcome Measures

Action Research Armtest part b Grip
performance with and without BCI/robotic device

Secondary Outcome Measures

Grip strength
Hand held dynamometer with and without BCI/robotic device
Bringing glass of water to the mouth
Ability to bring a glass of water to the mouth with and without BCI/robotic device

Full Information

First Posted
March 18, 2019
Last Updated
April 1, 2019
Sponsor
University of Aarhus
Collaborators
University of Aalborg, Denmark, The Danish National Rehabilitation Center for Neuromuscular Diseases, Bioservo Technologies AB, Sweden, Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03900247
Brief Title
Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface
Acronym
REMAP
Official Title
Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
University of Aalborg, Denmark, The Danish National Rehabilitation Center for Neuromuscular Diseases, Bioservo Technologies AB, Sweden, Aarhus University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
brain computer interface

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
REMAP EEG based BCI and SEM-Glove BioServo
Intervention Description
EEG-based brain computer interface (BCI) will be adapted to individual ALS patients and modified to control external robotic devices
Primary Outcome Measure Information:
Title
Action Research Armtest part b Grip
Description
performance with and without BCI/robotic device
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Grip strength
Description
Hand held dynamometer with and without BCI/robotic device
Time Frame
At 6 months
Title
Bringing glass of water to the mouth
Description
Ability to bring a glass of water to the mouth with and without BCI/robotic device
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Center of Functionally Integrative Neuroscience
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

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