Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

NeuroEnabling Technologies

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Device: Transcutaneous Electrical Spinal Cord Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01949285

NETI201309

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: SCI ASIA A, B, C

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Grp#1: sham stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Transcutaneous Electrical Spinal Cord Stimulation

Grp#2: Control

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous Electrical Spinal Cord Stimulation