ParalysisNCT01906424
Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
A study testing Transcutaneous Electrical Spinal Cord Stimulation in people with Paralysis and Spinal Cord Injury, run by NeuroEnabling Technologies, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paralysis, Spinal Cord Injury
- What is being tested?
- Transcutaneous Electrical Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to 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 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
Show all 12Show fewer
- 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
Who cannot join
- Pregnancy
- No functional segmental reflexes below the lesion
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California Los Angeles
Los Angeles, California, 90095
Strides SCI Functional Fitness
San Juan Capistrano, California, 92675
About this study
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.
Read the 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
- Being tested
- Transcutaneous Electrical Spinal Cord Stimulation
- Keywords
- spinal cord injury, quadriplegia, tetraplegia, stimulation
- Medical subject headings
- Paralysis, Spinal Cord Injuries, Quadriplegia
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 delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 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 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startApr 2016
- 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 ParalysisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 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 Terrafranca, DPM, Principal investigator, NeuroEnabling Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906424
- Sponsor's protocol ID
- NETI201307
- Status last verified
- Apr 2016
- First submitted
- 16 Jul 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
- Restoring Arm and Hand Function With Non-invasive Spinal Stimulation
- ClinicalTrials.gov ID
- NCT01906424
- Acronym / sponsor ID
- NETI201307
- Conditions
- Paralysis, Spinal Cord Injury
- Keywords
- spinal cord injury, quadriplegia, tetraplegia, stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- NeuroEnabling Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, California Institute of Technology
- Study start
- Apr 2016
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 24 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Grp#1: Training w/ and w/o Stim | Other | Device: Transcutaneous Electrical Spinal Cord StimulationControl- 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. |
| Grp#2: Training+Single Site Stimulation | Active comparator | Device: Transcutaneous Electrical Spinal Cord StimulationGroup #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 |
| Grp #3: Training + Two Site Stimualtion | Active comparator | Device: Transcutaneous Electrical Spinal Cord StimulationGroup #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 |
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 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
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 delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord. | Device | Control Grp#1: Training w/ and w/o Stim, Grp #3: Training + Two Site Stimualtion, Grp#2: Training+Single Site Stimulation |
Primary outcome
Improvement in sensorimotor function in arms and hands
Time frame: 12 weeks
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)
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 Terrafranca, DPM principal investigator
NeuroEnabling Technologies, Inc.
2 sites 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 Paralysis and Spinal Cord Injury, run by NeuroEnabling Technologies, Inc. at 2 sites 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 2 sites 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. 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 arms and hands (time frame: 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.