Clinical trial NCT01906424: Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
Official title: Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paralysis
Spinal Cord Injury
Keywords: spinal cord injury
quadriplegia
tetraplegia
stimulation
Lead sponsor: NeuroEnabling Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, Los Angeles
name: California Institute of Technology
First posted: 2013-07-24
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury.

Detailed description: This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury. The investigators hypothesize that this stimulation can revive spared function in the spinal cord of individuals who are clinically paralyzed, but who have some remaining connections between the brain and spinal cord. Our research has demonstrated that modifying the activation state of the spinal cord or awakening the spinal cord can benefit people with paralysis years after a spinal cord injury. This method and device have not yet been approved by the FDA for the treatment of paralysis and are under investigation. This study if successful will help provide further evidence that could be use to gain FDA approval.

Eligibility criteria: Inclusion Criteria: ASIA C

* Spinal cord injury 1 or more years prior
* Non progressive SCI at C7 or higher
* Half of key muscles below neurological level having a motor score of less than 2/5
* Ability to commit to home exercises and 12 week participation
* Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper extremity rehabilitation or testing activities
* Not dependent on ventilation support
* No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with upper extremity rehabilitation or testing activities
* No clinically significant depression or ongoing drug abuse
* Adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 12 week study period
* No current anti-spasticity regimen
* Must not have received botox injections in the prior six months
* Be unable to use upper extremity for functional tasks

Exclusion Criteria:

* Pregnancy
* No functional segmental reflexes below the lesion

Primary outcomes:
measure: Improvement in sensorimotor function in arms and hands
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: San Juan Capistrano
country: United States
facility: Strides SCI Functional Fitness
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Victor R Edgerton, PhD
role: STUDY_CHAIR
affiliation: NeuroEnabling Technologies, Inc.
name: Nicholas Terrafranca, DPM
role: PRINCIPAL_INVESTIGATOR
References: