Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

NCT ID: NCT01906424

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-12-31

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.

Detailed 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.

Conditions

Paralysis; Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: OTHER

Transcutaneous Electrical Spinal Cord Stimulation

Intervention Type: DEVICE

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

Grp#2: Training+Single Site Stimulation

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

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electrical Spinal Cord Stimulation

Intervention Type: DEVICE

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

Grp #3: Training + Two Site Stimualtion

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

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electrical Spinal Cord Stimulation

Intervention Type: DEVICE

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

Interventions

Transcutaneous Electrical Spinal Cord Stimulation

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

Intervention Type: DEVICE

Other Intervention Names

Prototype device

Eligibility Criteria

Inclusion Criteria

• 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

• 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 Terrafranca, DPM

Role: PRINCIPAL_INVESTIGATOR

NeuroEnabling Technologies, Inc.

Locations

University of California Los Angeles

Los Angeles, California, United States

Strides SCI Functional Fitness

San Juan Capistrano, California, United States

Countries

United States

Other Identifiers

NETI201307

Identifier Type: -

Identifier Source: org_study_id