Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

Not Applicable

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT01949285
• Lead Sponsor: NeuroEnabling Technologies, Inc.

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.

Study Timeline

• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-24
• Study Start: 2015-06
• Status Verified: 2016-04
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement in sensorimotor function in the lower extremities	10-12 weeks	Subjects will be tested by several measures of sensory and motor function, as well as self assessments of spasticity, quality of life, and independence. These tests include: American Spinal Injury Association (ASIA) scoring system, Spinal Cord Independence Measure (SCIM), Ashworth Spasticity Scale, Penn Spasm Frequency, Visual Analog Scale (VAS) for Spasticity, Electromyographic (EMG) recordings, Joint angle (goniometer) measures, kinematic analysis.

Secondary Outcome Measures

Name	Time	Method
Ability to stand independently	2-4 weeks	Subjects will be evaluated on their core body function and ability to stand

Trial Locations

Locations (1)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States