Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

NCT ID: NCT01949285

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Grp#1: sham stimulation

Group #1: Baseline clinical assessment; followed by two weeks training with no stimulation; then four weeks training + sham Transcutaneous Electrical Spinal Cord Stimulation; followed by repeat clinical assessment; then four weeks training + effective non-sham Transcutaneous Spinal Cord Stimulation; repeat clinical assessment.

Secondary outcome measurements: assess ability to stand with and without stimulation using a stance frame support; assess trunk function (core stability) with and without stimulation

Group Type: SHAM_COMPARATOR

Transcutaneous Electrical Spinal Cord Stimulation

Intervention Type: DEVICE

A prototype device that non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function.

Grp#2: Control

Group #2: Baseline clinical assessment; followed by two weeks training with no Transcutaneous Electrical Spinal Cord Stimulation; then four weeks training + effective Transcutaneous Electrical Spinal Cord Stimulation; followed by repeat clinical assessment.

Secondary outcome measurements: assess ability to stand with and without stimulation using a stance frame support; assess trunk function (core stability) with and without stimulation

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electrical Spinal Cord Stimulation

Intervention Type: DEVICE

A prototype device that non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Prototype Device

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

California Institute of Technology

OTHER

Sponsor Role: collaborator

NeuroEnabling Technologies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor R Edgerton, PhD

Role: STUDY_CHAIR

University of California, Los Angeles

Nicholas A Terrafranca, DPM

Role: PRINCIPAL_INVESTIGATOR

NeuroEnabling Technologies, Inc.

Locations

University of California Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

NETI201309

Identifier Type: -

Identifier Source: org_study_id