Spinal Cord InjuryPhase 1NCT02336321
Daily-life Brain Control Of A Hand Exoskeleton After Cervical Spinal Cord Injury
A Phase 1 study of Spinal Cord Injury, run by University Hospital Tuebingen at 1 site in Spain.
Trial summary
In this study, 6 volunteer participants with chronic spinal cord injury will be invited to use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction (BNCI) system fusing electroencephalography (EEG) and electrooculography (EOG) to detect the intention of the user to grasp objects of… Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to May 2015
- Phase
- Phase 1
- 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 15 to 65 years
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B \& C (Lower Extremity Motor Score <20)
- Motor level of injury from cervical level 4 to cervical level 7, according to ASIA guidelines
- Male and non-pregnant, non-lactating female
- Age 15-65 years old
- At least 12 months after injury
Who cannot join
- History of severe neurological injuries other than spinal cord injury (e.g. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
- Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study
- Unstable spine or unhealed limbs or pelvic fractures
- Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus
- Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.
- Psychiatric or cognitive conditions that may interfere with the trial
- Patients incapable of providing informed consent
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Guttmann, Hospital de Neurorehabilitació
Badalona, Catalonia, 08916
About this study
Official title: Restoration of Daily-life Hand Function Using a Brain/Neural-Computer Interaction (BNCI) System in Paralysis After Cervical Spinal Cord Injury
In this study, 6 volunteer participants with chronic spinal cord injury will be invited to use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction (BNCI) system fusing electroencephalography (EEG) and electrooculography (EOG) to detect the intention of the user to grasp objects of daily life. The BNCI system consists of a lightweight hand exoskeleton connected to portable motors, rechargeable batteries and a computerized control system integrated into a wheelchair. Before, during and after use of the BNCI system the volunteers will perform standardized assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on motor function in performing daily life actions while psychological outcomes primarily focus on safety, reliability as well as predisposition and perceptions of disability.
- Conditions
- Spinal Cord Injury
- Being tested
- BNCI controlled hand exoskeleton
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNCI controlled hand exoskeletonDevice
The BNCI system fuses and translates bio-signals related to user intention into control signals of an assistive device performing grasping motions
| Study group | Role | What they receive |
|---|---|---|
| BNCI hand-exoskeleton | Experimental | Hand motor function before, during and after application of the device Receives: Device: BNCI controlled hand exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) Score
The TRI-HFT will be applied once before and while the patients wear the hand exoskeleton
Measured: Hand function will be assessed twice on the same day. Once before the hand exoskeleton is applied (absence of the assistive device) and once after the brain-controlled hand exoskeleton was attached to the patients' hand and arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startApr 2014
- Primary completionOct 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Guttmann, Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336321
- Sponsor's protocol ID
- 288551-2
- Other IDs
- SO-932, WAY-288551, 01GQ0831
- Status last verified
- Mar 2014
- First submitted
- 19 Dec 2014
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Soekadar SR, Witkowski M, Vitiello N, Birbaumer N. An EEG/EOG-based hybrid brain-neural computer interaction (BNCI) system to control an exoskeleton for the paralyzed hand. Biomed Tech (Berl). 2015 Jun;60(3):199-205. doi: 10.1515/bmt-2014-0126.
PubMed 25490027Witkowski M, Cortese M, Cempini M, Mellinger J, Vitiello N, Soekadar SR. Enhancing brain-machine interface (BMI) control of a hand exoskeleton using electrooculography (EOG). J Neuroeng Rehabil. 2014 Dec 16;11:165. doi: 10.1186/1743-0003-11-165.
PubMed 25510922Cempini M, De Rossi SM, Lenzi T, Cortese M, Giovacchini F, Vitiello N, Carrozza MC. Kinematics and design of a portable and wearable exoskeleton for hand rehabilitation. IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650414. doi: 10.1109/ICORR.2013.6650414.
PubMed 24187233Cempini M, Marzegan A, Rabuffetti M, Cortese M, Vitiello N, Ferrarin M. Analysis of relative displacement between the HX wearable robotic exoskeleton and the user's hand. J Neuroeng Rehabil. 2014 Oct 18;11:147. doi: 10.1186/1743-0003-11-147.
PubMed 25326697
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Daily-life Hand Function Using a Brain/Neural-Computer Interaction (BNCI) System in Paralysis After Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02336321
- Acronym / sponsor ID
- 288551-2
- Conditions
- Spinal Cord Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Institut Guttmann, Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento
- Study start
- Apr 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Jan 2015 (estimated)
- 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.
In this study, 6 volunteer participants with chronic spinal cord injury will be invited to use an autonomous hand exoskeleton device controlled by a brain/neural-computer interaction (BNCI) system fusing electroencephalography (EEG) and electrooculography (EOG) to detect the intention of the user to grasp objects of daily life. The BNCI system consists of a lightweight hand exoskeleton connected to portable motors, rechargeable batteries and a computerized control system integrated into a wheelchair. Before, during and after use of the BNCI system the volunteers will perform standardized assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on motor function in performing daily life actions while psychological outcomes primarily focus on safety, reliability as well as predisposition and perceptions of disability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BNCI hand-exoskeleton | Experimental | Device: BNCI controlled hand exoskeletonHand motor function before, during and after application of the device |
Who may qualify
- Ages
- 15 to 65 years
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B \& C (Lower Extremity Motor Score <20)
- Motor level of injury from cervical level 4 to cervical level 7, according to ASIA guidelines
- Male and non-pregnant, non-lactating female
- Age 15-65 years old
- At least 12 months after injury
Key exclusion criteria (7 listed)
- History of severe neurological injuries other than spinal cord injury (e.g. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
- Concurrent medical diseases (eg. infections, circulatory, heart or lung, pressure sores) interfering with the study
- Unstable spine or unhealed limbs or pelvic fractures
- Severe spasticity (Ashworth grade 4; ie. Affected part(s) rigid in flexion or extension) or uncontrolled clonus
- Diagnosis of severe osteoporosis/penia as proven with pQCT or DXA.
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 |
|---|---|---|
| BNCI controlled hand exoskeletonThe BNCI system fuses and translates bio-signals related to user intention into control signals of an assistive device performing grasping motions | Device | BNCI hand-exoskeleton |
Primary outcome
Change of Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) Score
Time frame: Hand function will be assessed twice on the same day. Once before the hand exoskeleton is applied (absence of the assistive device) and once after the brain-controlled hand exoskeleton was attached to the patients' hand and arm.
The TRI-HFT will be applied once before and while the patients wear the hand exoskeleton
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
- Background: PubMed 25490027Soekadar SR, Witkowski M, Vitiello N, Birbaumer N. An EEG/EOG-based hybrid brain-neural computer interaction (BNCI) system to control an exoskeleton for the paralyzed hand. Biomed Tech (Berl). 2015 Jun;60(3):199-205. doi: 10.1515/bmt-2014-0126.
- Background: PubMed 25510922Witkowski M, Cortese M, Cempini M, Mellinger J, Vitiello N, Soekadar SR. Enhancing brain-machine interface (BMI) control of a hand exoskeleton using electrooculography (EOG). J Neuroeng Rehabil. 2014 Dec 16;11:165. doi: 10.1186/1743-0003-11-165.
- Background: PubMed 24187233Cempini M, De Rossi SM, Lenzi T, Cortese M, Giovacchini F, Vitiello N, Carrozza MC. Kinematics and design of a portable and wearable exoskeleton for hand rehabilitation. IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650414. doi: 10.1109/ICORR.2013.6650414.
- Background: PubMed 25326697Cempini M, Marzegan A, Rabuffetti M, Cortese M, Vitiello N, Ferrarin M. Analysis of relative displacement between the HX wearable robotic exoskeleton and the user's hand. J Neuroeng Rehabil. 2014 Oct 18;11:147. doi: 10.1186/1743-0003-11-147.
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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 Phase 1 study of Spinal Cord Injury, run by University Hospital Tuebingen at 1 site in Spain.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 14 May 2015. 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 Spain. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) Score (time frame: Hand function will be assessed twice on the same day. Once before the hand exoskeleton is applied (absence of the assistive device) and once after the brain-controlled hand exoskeleton was attached to the patients' hand and arm.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02336321, which also lists 4 linked publications.
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 14 May 2015.