Clinical trial NCT01949285: Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs
Official title: A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury
Paralysis
Rehabilitation
Assessment
Theranostics
Lead sponsor: NeuroEnabling Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, Los Angeles
name: California Institute of Technology
First posted: 2013-09-24
Enrollment: 10
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: BASIC_SCIENCE

Brief summary: This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.

Detailed description: This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.

The investigators hypothesize that this type of stimulation can be used to locate and determine if any spinal (nerve) pathways or connections were spared following a spinal cord injury. We also hypothesize the same stimulation can help revive or recover function to muscles connected to these spared spinal (nerve) pathways in individuals who are clinically paralyzed. Our research has demonstrated that modifying the activation state of the spinal cord after an injury, 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 one day to gain FDA approval.

Eligibility criteria: Inclusion Criteria: SCI ASIA A, B, C

* Spinal cord injury 1 or more years prior
* Non progressive cervical or thoracic SCI
* Half of key muscles below neurological level having a motor score of less than 2/5
* Ability to commit to home exercises and 16 week participation
* Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in lower 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 lower 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 16 week study period
* No current anti-spasticity regimen
* Must not have received botox injections in the prior six months
* Be unable to use lower extremity for functional tasks

Exclusion Criteria:

* Pregnancy
* No functional segmental reflexes below the lesion

Primary outcomes:
measure: Improvement in sensorimotor function in the lower extremities
timeFrame: 10-12 weeks
Secondary outcomes:
measure: Ability to stand independently
timeFrame: 2-4 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Victor R Edgerton, PhD
role: STUDY_CHAIR
affiliation: NeuroEnabling Technologies, Inc.
name: Nicholas A Terrafranca, DPM
role: PRINCIPAL_INVESTIGATOR
References: