Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

Spinal Cord Injury Clinical Trial

Official title:

Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906424
• Other study ID #: NETI201307
• Status: Completed
• Phase: N/A
• First received: July 16, 2013
• Last updated: January 20, 2017
• Start date: April 2016
• 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 help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• 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: 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

Related Conditions & MeSH terms

• Paralysis
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Transcutaneous Electrical Spinal Cord Stimulation
A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California
United States	Strides SCI Functional Fitness	San Juan Capistrano	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 arms and hands	Subjects will be tested by several measures of sensory and motor function, as well as self-assessments regarding quality of life and independence, at the beginning of the study and at each testing session. These tests include: American Spinal Injury Association (ASIA) scoring system. Box and block CUE (Capabilities of Upper Extremity) GRASSP (Graded Redefined Assessment of Strength, Sensibility and Prehension) SCIM (Spinal Cord Independence Measure); Ashworth Spasticity scale: Penn Spasm Frequency VAS (Visual Analog Scale) for Spasticity)	12 weeks