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

Spinal Cord Injury Clinical Trial

Official title:

Restoration of Daily-life Hand Function Using a Brain/Neural-Computer Interaction (BNCI) System in Paralysis After Cervical Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336321
• Other study ID #: 288551-2
• Secondary ID: SO-932WAY-288551
• Status: Completed
• Phase: Phase 1
• First received: December 19, 2014
• Last updated: May 13, 2015
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2014
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Departament de Salut de la Generalitat de Catalunya
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• 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

Locations

Country	Name	City	State
Spain	Instituto Guttmann, Hospital de Neurorehabilitació	Badalona	Catalonia

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Institut Guttmann, Scuola Superiore Sant’Anna di Studi Universitari e di Perfezionamento

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No

External Links

•   Project Website