Cervical Spinal Cord InjuryPhase 1/2NCT02313194
Spinal Cord Neuromodulation for Spinal Cord Injury
A Phase 1/2 study testing Epidural Stimulation and Buspirone in people with Cervical Spinal Cord Injury and Tetraparesis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spinal Cord Injury, Tetraparesis, Tetraplegia
- What is being tested?
- Epidural Stimulation and Buspirone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 30 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement
- No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease.
- No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training
- No clinically significant depression or ongoing drug abuse
- No current anti-spasticity medication regimen
- Non-progressive SCI above C5
Show all 16Show fewer
- Must not have received botox injections in the prior six months
- Be unable to grip or move independently
- Be at least one-year post injury
- Must be at least 18 years of age
- Segmental reflexes remain functional below the lesion
- Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception
- No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation
- No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery
- Must not be involved in another clinical trial
- Must not have disorders or conditions that would require MRI monitoring
Who cannot join
- None as long as inclusion criteria are met.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI
This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.
Read the detailed description
An epidural stimulation device will be tested to determine if motor function can be improved.
- Conditions
- Cervical Spinal Cord Injury, Tetraparesis, Tetraplegia
- Being tested
- Epidural Stimulation, Buspirone
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural StimulationDevice
Determine if epidural stimulation can improve motor function
BuspironeDrug
Determine if the pharmacological agent in combination with the stimulator can improve motor function.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Experimental | Determine if epidural stimulation can improve motor function. Receives: Device: Epidural Stimulation; Drug: Buspirone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of arm/hand function
Formal motor testing
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJul 2013
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lu, MD, PhD, University of California, Los Angeles
- Investigators
- Daniel C Lu, MD PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313194
- Sponsor's protocol ID
- 12-001416
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2014
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Forelimb Function With Agonist Drug and Epidural Stimulation in SCI
- ClinicalTrials.gov ID
- NCT02313194
- Acronym / sponsor ID
- 12-001416
- Conditions
- Cervical Spinal Cord Injury, Tetraparesis, Tetraplegia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Dec 2014 (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 designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.
Detailed description
An epidural stimulation device will be tested to determine if motor function can be improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Device: Epidural Stimulation, Drug: BuspironeDetermine if epidural stimulation can improve motor function. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement
- No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease.
- No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training
- No clinically significant depression or ongoing drug abuse
- No current anti-spasticity medication regimen
Key exclusion criteria (1 listed)
- None as long as inclusion criteria are met.
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 |
|---|---|---|
| Epidural StimulationDetermine if epidural stimulation can improve motor function | Device | Stimulation |
| BuspironeDetermine if the pharmacological agent in combination with the stimulator can improve motor function. | Drug | Stimulation |
Primary outcome
Assessment of arm/hand function
Time frame: 24 months
Formal motor testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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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.
Daniel C Lu, MD PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epidural Stimulation and Buspirone in people with Cervical Spinal Cord Injury and Tetraparesis, run by University of California, Los Angeles 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 16 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Assessment of arm/hand function (time frame: 24 months). 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 13 Feb 2026.