Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

NCT01906424 | Completed DMC

• 1 other identifier: NETI201307
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Paralysis; Spinal Cord Injury

Keywords

spinal cord injury; quadriplegia; tetraplegia; stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control Grp#1: Training w/ and w/o Stim

OTHER

Control- Group #1: 4 weeks training without any transcutaneous electrical stimulation followed by 2 weeks of training plus transcutaneous electrical spinal cord stimulation applied to one or two locations of the cervical (neck) region of the spinal cord.

Device: Transcutaneous Electrical Spinal Cord Stimulation

Grp#2: Training+Single Site Stimulation

ACTIVE COMPARATOR

Group #2: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to one location along the cervical (neck) region of the spinal cord; followed by 2 weeks of training without stimulation

Device: Transcutaneous Electrical Spinal Cord Stimulation

Grp #3: Training + Two Site Stimualtion

ACTIVE COMPARATOR

Group #3: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to two locations along the cervical (neck) region of the spinal cord; followed by 2 weeks of training without stimulation

Device: Transcutaneous Electrical Spinal Cord Stimulation

Interventions

Transcutaneous Electrical Spinal Cord Stimulation DEVICE

A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.

Also known as: Prototype device

Control Grp#1: Training w/ and w/o Stim; Grp #3: Training + Two Site Stimualtion; Grp#2: Training+Single Site Stimulation

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 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

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 (2)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Strides SCI Functional Fitness

San Juan Capistrano, California, 92675, United States

Location

MeSH Terms

Conditions

Paralysis; Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

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

Study Officials

• Victor R Edgerton, PhD

  University of California, Los Angeles

  STUDY CHAIR

• Nicholas Terrafranca, DPM

  NeuroEnabling Technologies, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 24, 2013
• Study Start: April 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: January 24, 2017

Record last verified: 2016-04

Locations

US (2)