Hand Grasp Function After Spinal Cord Injury

Battelle Memorial Institute

Status

Completed

Conditions

Spinal Cord Injuries

Treatments

Device: User-controlled FES system

Study type

Interventional

Funder types

Other

Identifiers

NCT05128994

100144033

Details and patient eligibility

About

The objective of this study is to advance personalized, portable, and non-invasive hand-grasp neuro-orthoses that restore naturalistic grasp functions for those with tetraplegia due to spinal cord injury (SCI), designed around their needs and preferences.

Full description

Battelle has developed a novel wearable sleeve that can reanimate a paralyzed limb via Functional Electrical Stimulation (FES) that is controlled non-invasively by the user. Previous work has shown the ability of this sleeve and FES technology to significantly enhance independence and quality of life when controlled by an implanted brain-computer interface, thus now investigators plan to trial use of the high-definition FES system with simpler, non-invasive control mechanisms to expedite translation of this technology into real-world settings. Each participant will complete up to 10 research sessions (~1.5hrs each) in their residence or at an alternative location. The study location is restricted to Columbus Ohio and surrounding areas. Participants will be compensated for their time.

In Aim 1, investigators will evaluate the ability of a non-invasive, user-controlled FES system to increase functional hand use in the homes of individuals with SCI. The research team will train participants to use the FES system for different functional hand movements and activities they identify as important to them, then measure FES system effectiveness using standardized assessments.

In Aim 2, investigators will assess the viability of using the sleeve technology to non-invasively record muscle activity as the participant attempts different functional movements.

In Aim 3, human-centric design methodology and contextual inquiry interviews will be employed to understand study participants' needs and preferences for a FES assistive device. This information will determine actions to improve usability and optimize the system for unsupervised home use.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥ 18 years old
≥ 12 months post-SCI and medically/neurologically stable
Cervical spinal cord injury (C1-C8); any etiology except neurodegenerative conditions
Unable to grasp objects independently with both hands (tetraplegia)
Manual muscle testing (MMT) scores ≥4/5 for elbow flexion and ≥2/5 for wrist extension
Willing to participate in sessions at home or able to travel to alternate site for study sessions

Exclusion criteria

Ventilator-dependent (dependent upon mechanical life support due to inability to breathe effectively)
Poorly controlled autonomic dysreflexia (more than one episode in 3 months prior to enrollment)
Moderate to severe spasticity (Modified Ashworth Scale (MAS) >1+) in the hand, wrist, or forearm
Received a localized injection (e.g. Botox) to hand, wrist, or forearm muscles within past 12 months
Currently participating in physical rehabilitation for upper extremity impairments
Individuals having or requiring any of the following: implanted pacemaker, life supporting/sustaining equipment, or critical non-removable implantable electronic devices such as an insulin pump or neurostimulator.
Presence of any other clinically significant medical comorbidity and/or neurological condition for which participation in the study may pose a safety risk and/or influence results
Presence of the following medical conditions: uncontrolled seizure disorder, active malignancy in the upper extremities, or open wounds/infections in the upper extremities
Individuals whose forearm is determined to be too small or too large to fit the electrode sleeve being investigated
Individuals who are pregnant or plan to get pregnant during the course of the study