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Status unknownNCT03900247REMAPUpdated Apr 2, 2019

Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface

An interventional study of REMAP EEG based BCI and SEM-Glove BioServo in Amyotrophic Lateral Sclerosis, sponsored by University of Aarhus. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-04-02.

Sponsored by University of Aarhus · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
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Study 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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • brain computer interface
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In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's planned enrollment of 15 is below the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Other severe Neurological or Psychiatric disease
  • Drug or Alcohol dependency
  • Pregnancy
  • Severe cognitive disturbances found to impede with study completion
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Interventions

  • DeviceREMAP 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

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What researchers measure

Primary outcomes

  1. Action Research Armtest part b Grip

    performance with and without BCI/robotic device

    Time frame: At 6 months

Secondary outcomes

  1. Grip strength

    Hand held dynamometer with and without BCI/robotic device

    Time frame: At 6 months

  2. Bringing glass of water to the mouth

    Ability to bring a glass of water to the mouth with and without BCI/robotic device

    Time frame: At 6 months

07

Study locations

1 site
  • Center of Functionally Integrative Neuroscience
    Aarhus, 8000, Denmark
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03900247
Lead sponsor
University of Aarhus
Collaborators
University of Aalborg, Denmark, The Danish National Rehabilitation Center for Neuromuscular Diseases, Bioservo Technologies AB, Sweden, Aarhus University Hospital
Responsible party
Sponsor
First posted
Apr 2, 2019
Start date
Mar 18, 2019
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Apr 2, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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