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

NCT02336321 | Completed Phase 1 DMC

• 4 other identifiers: 288551-2SO-932WAY-28855101GQ0831
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

Study Arms (1)

BNCI hand-exoskeleton

EXPERIMENTAL

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

Device: BNCI controlled hand exoskeleton

Interventions

BNCI controlled hand exoskeleton DEVICE

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

BNCI hand-exoskeleton

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Institut Guttmann: collaborator
• Scuola Superiore Sant'Anna di Studi Universitari e di Perfezionamento: collaborator

Study Sites (1)

Instituto Guttmann, Hospital de Neurorehabilitació

Badalona, Catalonia, 08916, Spain

Location

Related Publications (4)

• 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.

  PMID: 25490027 BACKGROUND

• 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.

  PMID: 25510922 BACKGROUND

• 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.

  PMID: 24187233 BACKGROUND

• 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.

  PMID: 25326697 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: January 12, 2015
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 14, 2015

Record last verified: 2014-03

Locations

ES (1)