Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

NeuroEnabling Technologies

Status: Completed

Conditions: Spinal Cord Injury; Paralysis

Treatments: Device: Transcutaneous Electrical Spinal Cord Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01906424

NETI201307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

7 participants in 3 patient groups

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

Other group

Description:

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.

Treatment:

Device: Transcutaneous Electrical Spinal Cord Stimulation

Grp#2: Training+Single Site Stimulation

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous Electrical Spinal Cord Stimulation

Grp #3: Training + Two Site Stimualtion

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous Electrical Spinal Cord Stimulation