Spinal Cord InjuryNCT01949285
Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs
A study testing Transcutaneous Electrical Spinal Cord Stimulation in people with Spinal Cord Injury, run by NeuroEnabling Technologies, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Transcutaneous Electrical Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Pregnancy
- No functional segmental reflexes below the lesion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI
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.
Read the detailed 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Transcutaneous Electrical Spinal Cord Stimulation
- Keywords
- Spinal cord injury, Paralysis, Rehabilitation, Assessment, Theranostics
- Medical subject headings
- Spinal Cord Injuries, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Spinal Cord StimulationDevice
Also called Prototype 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Transcutaneous Electrical Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10-12 weeks
Secondary outcomes (1)
Ability to stand independently
Subjects will be evaluated on their core body function and ability to stand
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startJun 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroEnabling Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, California Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Victor R Edgerton, PhD, Study chair, University of California, Los AngelesNicholas A Terrafranca, DPM, Principal investigator, NeuroEnabling Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949285
- Sponsor's protocol ID
- NETI201309
- Status last verified
- Apr 2016
- First submitted
- 19 Sep 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI
- ClinicalTrials.gov ID
- NCT01949285
- Acronym / sponsor ID
- NETI201309
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury, Paralysis, Rehabilitation, Assessment, Theranostics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NeuroEnabling Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, California Institute of Technology
- Study start
- Jun 2015
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grp#1: sham stimulation | Sham comparator | Device: Transcutaneous Electrical Spinal Cord StimulationGroup #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 |
| Grp#2: Control | Active comparator | Device: Transcutaneous Electrical Spinal Cord StimulationGroup #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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy
- No functional segmental reflexes below the lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Spinal Cord StimulationAlso: Prototype DeviceA prototype device that non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function. | Device | Grp#1: sham stimulation, Grp#2: Control |
Primary outcome
Improvement in sensorimotor function in the lower extremities
Time frame: 10-12 weeks
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.
1 secondary outcome
Ability to stand independently
Time frame: 2-4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor R Edgerton, PhD study chair
University of California, Los Angeles
Nicholas A Terrafranca, DPM principal investigator
NeuroEnabling Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Spinal Cord Stimulation in people with Spinal Cord Injury, run by NeuroEnabling Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in sensorimotor function in the lower extremities (time frame: 10-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017; AzTrials last refreshed its copy on 26 Oct 2026.