Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

Spinal Cord Injury Clinical Trial

Official title:

A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949285
• Other study ID #: NETI201309
• Status: Completed
• Phase: N/A
• First received: September 19, 2013
• Last updated: January 20, 2017
• Start date: June 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: April 2016
• Source: NeuroEnabling Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Transcutaneous Electrical Spinal Cord Stimulation
A prototype device that non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function.

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
NeuroEnabling Technologies, Inc.	California Institute of Technology, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in sensorimotor function in the lower extremities	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.	10-12 weeks
Secondary	Ability to stand independently	Subjects will be evaluated on their core body function and ability to stand	2-4 weeks