Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

NCT01949285 | Completed

• 1 other identifier: NETI201309
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; Paralysis; Rehabilitation; Assessment; Theranostics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ability to stand independently

  2-4 weeks

Study Arms (2)

Grp#1: sham stimulation

SHAM COMPARATOR

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

Device: Transcutaneous Electrical Spinal Cord Stimulation

Grp#2: Control

ACTIVE COMPARATOR

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

Device: Transcutaneous Electrical Spinal Cord Stimulation

Interventions

Transcutaneous Electrical Spinal Cord Stimulation 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.

Also known as: Prototype Device

Grp#1: sham stimulation; Grp#2: Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• No functional segmental reflexes below the lesion

Sponsors & Collaborators

• NeuroEnabling Technologies, Inc.: lead
• University of California, Los Angeles: collaborator
• California Institute of Technology: collaborator

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Paralysis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Victor R Edgerton, PhD

  University of California, Los Angeles

  STUDY CHAIR

• Nicholas A Terrafranca, DPM

  NeuroEnabling Technologies, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: September 24, 2013
• Study Start: June 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: January 24, 2017

Record last verified: 2016-04

Locations

US (1)