Amyotrophic Lateral SclerosisREMAPNCT03900247
Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface
A study testing REMAP EEG based BCI and SEM-Glove BioServo in people with Amyotrophic Lateral Sclerosis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- REMAP EEG based BCI and SEM-Glove BioServo
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Mar 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other severe Neurological or Psychiatric disease
- Drug or Alcohol dependency
- Pregnancy
- Severe cognitive disturbances found to impede with study completion
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- REMAP EEG based BCI and SEM-Glove BioServo
- Keywords
- brain computer interface
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMAP EEG based BCI and SEM-Glove BioServoDevice
EEG-based brain computer interface (BCI) will be adapted to individual ALS patients and modified to control external robotic devices
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Armtest part b Grip
performance with and without BCI/robotic device
Measured: At 6 months
Secondary outcomes (2)
Grip strength
Hand held dynamometer with and without BCI/robotic device
Measured: At 6 months
Bringing glass of water to the mouth
Ability to bring a glass of water to the mouth with and without BCI/robotic device
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start18 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University, The Danish National Rehabilitation Center for Neuromuscular Diseases, Bioservo Technologies AB, Sweden, Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900247
- Sponsor's protocol ID
- 6153-00010A
- Acronym
- REMAP
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restore Motor Function Through Robotic Arm Exoskeleton and Brain Computer Interface
- ClinicalTrials.gov ID
- NCT03900247
- Acronym / sponsor ID
- REMAP / 6153-00010A
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- brain computer interface
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aalborg University, The Danish National Rehabilitation Center for Neuromuscular Diseases, Bioservo Technologies AB, Sweden, Aarhus University Hospital
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Other severe Neurological or Psychiatric disease
- Drug or Alcohol dependency
- Pregnancy
- Severe cognitive disturbances found to impede with study completion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMAP EEG based BCI and SEM-Glove BioServoEEG-based brain computer interface (BCI) will be adapted to individual ALS patients and modified to control external robotic devices | Device | – |
Primary outcome
Action Research Armtest part b Grip
Time frame: At 6 months
performance with and without BCI/robotic device
2 secondary outcomes
Grip strength
Time frame: At 6 months
Bringing glass of water to the mouth
Time frame: At 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMAP EEG based BCI and SEM-Glove BioServo in people with Amyotrophic Lateral Sclerosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Armtest part b Grip (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.