Daily-life Brain Control Of A Hand Exoskeleton After Cervical Spinal Cord Injury

NCT ID: NCT02336321

Last Updated: 2015-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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BNCI hand-exoskeleton

Hand motor function before, during and after application of the device

Group Type EXPERIMENTAL

BNCI controlled hand exoskeleton

Intervention Type DEVICE

The BNCI system fuses and translates bio-signals related to user intention into control signals of an assistive device performing grasping motions

Interventions

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BNCI controlled hand exoskeleton

The BNCI system fuses and translates bio-signals related to user intention into control signals of an assistive device performing grasping motions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Institut Guttmann

OTHER

Sponsor Role collaborator

Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Instituto Guttmann, Hospital de Neurorehabilitació

Badalona, Catalonia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 25490027 (View on PubMed)

Witkowski 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.

Reference Type BACKGROUND
PMID: 25510922 (View on PubMed)

Cempini 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.

Reference Type BACKGROUND
PMID: 24187233 (View on PubMed)

Cempini 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.

Reference Type BACKGROUND
PMID: 25326697 (View on PubMed)

Other Identifiers

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SO-932

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

WAY-288551

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

01GQ0831

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

288551-2

Identifier Type: -

Identifier Source: org_study_id

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