Spinal Cord InjuryISMSNCT02899858
Restoration of Standing and Walking With ISMS in Humans
A study testing Movement Assessment, MRI Scan and IntraSpinal Micro-Stimulation in people with Spinal Cord Injury and Paralysis, run by Vanderbilt University at 1 site in United States.
Trial summary
Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to stand and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20 years, clinicians have tried to reengage such these circuits for standing and walking in the lower spinal cord of paralyzed humans through… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Spinal Cord Injury, Paralysis
- What is being tested?
- Movement Assessment, MRI Scan and IntraSpinal Micro-Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Oct 2019
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years old; male or female (no preference).
- Complete paraplegia (ASIA A classification) as a result of a spinal cord injury between the levels of T2-8.
- No motor or sensory function below the level of injury as determined by a physician.
- No voluntary bladder function - defined as the inability to sense bladder fullness or voluntary contraction of the bladder (meets criteria for no sacral sparing).
- Stable paraplegia.
- Patients with involuntary spasms are allowed. However, spasticity must be less than Ashworth 4 or spasm rating of 3 or less.
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- History of spinal cord injury greater than 1 year.
- Intent to undergo spine surgery involving exposure of at least T9-T12 vertebral lamina.
- MRI studies performed within the past year showing presence of spinal cord between T8-L1 with reasonable normal anatomical shape. No chronic infections.
- Ability to travel to Vanderbilt Medical Center.
Who cannot join
- Acute medical conditions that are under active treatment. Examples include active urinary tract infection, respiratory illness, decubital ulcers, fractures, upper extremity injury, back pain.
- Pregnancy.
- Presence of a neurostimulator, bladder stimulator, cardiac stimulator or other electrical stimulator device implant.
- Inability to transfer from wheel chair to chair or bed.
- Inability to tolerate 1 hour of physical activity such as gait training in a harness.
- Severe depression requiring active medical treatment or counseling.
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- Cognitive impairment that places the study volunteer under the 6th grade reading level.
- Inability to provide consent.
- Intradural or extradural masses compressing or displacing the spinal cord between T8-L1 region.
- Significant change in motor or sensory function over the previous year.
- History of spinal cord injury less than 1 year.
- Previous laminectomy and intradural spinal cord procedure involving the region of T9-T12.
- Patients with involuntary spasms with rigidity more than Ashworth 4 or spasm rating of 3 or more.
Trial locations and contacts
1 site in 1 country.
About this study
Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to stand and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20 years, clinicians have tried to reengage such these circuits for standing and walking in the lower spinal cord of paralyzed humans through novel paradigms of physical therapy, pharmacological stimulation of the spinal cord, or recently - epidural stimulation of the spinal cord. Although standing and stepping with these maneuvers are rudimentary at best, these human studies offer promise to restore controlled, lower extremity movement to the spinal cord injured (SCI) individual. Evidence from animal data suggests that more focal activation of intraspinal circuitry (IntraSpinal Micro-Stimulation - ISMS) would produce more fatigue resistant, natural standing and stepping activity in humans. To date, there has been no direct confirmation of such circuitry in the spinal cord of bipedal humans who have been paralyzed. Furthermore, mapping of such circuitry would provide the basis of a novel intraspinal neuroprosthetic that should be able to restore control of standing or walking in a manner that is much more physiologically normal and tolerable than by stimulating each individual muscle group. Proof of the existence of these spinal circuits in man, and the ability to activate and control these circuits by first mapping the spinal cord is the basis of this proposal.
Read the detailed description
Two study volunteers who are completely paralyzed (T2-8 region) to undergo an evaluation of ISMS during an otherwise normal thoracic spinal surgical procedure.
The potential volunteers will be asked to review and sign a screening consent form prior to initial screening. This is to ensure that the ideal two patients are selected for this study and that foreseeable issues are identified and risks minimized for the volunteers. The subjects must have a stable, complete spinal cord injury involving their upper thoracic spinal cord (T2-8 region), and are otherwise planning to undergo a spine surgery involving the lower thoracic spinal cord.
Subjects who have volunteered for this study will undergo their intended spinal surgery by the clinical team. The usual indications for undergoing such a surgery is either to correct a deformity involving the lower thoracic region, or stabilizing the lower thoracic region due to chronic instability from degenerative disease. The surgery intended for clinical treatment must involve exposure of the T9-T12 spinal lamina. However, exposure of the spinal cord through a dural opening would not normally be performed in this clinical scenario. The experimental portion of the surgery begins then, with a laminectomy of T9-T12 and exposure of the spinal cord through a durotomy using standard neurosurgical techniques for spinal cord exposure. The spinal cord in this region will then be mapped and stimulated using ISMS and the effects on the legs measured to determine if the circuitry exists to potentially allow standing or walking through the use of ISMS. The research requests subjects to specifically allow 2 hours of extra time during the routine spinal surgery to perform this study.
- Conditions
- Spinal Cord Injury, Paralysis
- Being tested
- Movement Assessment, MRI Scan, IntraSpinal Micro-Stimulation, Follow up clinical exam, Post Op MRI Scan
- Keywords
- Thoracic spinal cord injury, Paralysis, ASIA A, Device
- 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.
Movement AssessmentOther
Documentation of ASIA A (T2-8) status at Belmont Gait Lab
MRI ScanOther
Total MRI of spine to evaluate condition of spinal cord
IntraSpinal Micro-StimulationProcedure or surgery
IntraSpinal Micro-Stimulation will be performed using a maximum of 16 electrodes inserted along each side of spinal cord that correlate with movements created across all 3 joints (hips, knees, and ankles)
Follow up clinical examOther
All subjects will be expected to return for a follow-up visit with Drs. Konrad at 1, 3 and 6 month follow up visits.
Post Op MRI ScanOther
An MRI will be obtained at 3 months following the procedure to document the impact of the mapping procedure on spinal cord anatomy.
Follow up gait assessmentOther
Follow-up assessment with the Belmont Gait Lab will be performed at the 6 month follow up visit
| Study group | Role | What they receive |
|---|---|---|
| IntraSpinal Micro-Stimulation | Experimental | IntraSpinal Micro-Stimulation will be performed using a maximum of 16 electrodes inserted along each side of spinal cord that correlate with movements created across all 3 joints (hips, knees, and ankles) Receives: Other: Movement Assessment; Other: MRI Scan; Procedure: IntraSpinal Micro-Stimulation; Other: Follow up clinical exam; Other: Post Op MRI Scan; Other: Follow up gait assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
IntraSpinal Micro-Stimulation
Movement of either or both lower extremities while the subject is anesthetized during routine spinal surgery will be performed.
Measured: 3 years
Secondary outcomes (1)
ISMS data collection:
Kinesiology measurement data collected from Dr. Robinson's Gait lab preoperatively will be compared with intraoperative movement data.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 2015 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: Funding stopped and no one met IRB approved enrollment criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, Belmont University
- Responsible party
- Principal investigator, Peter Konrad, Vanderbilt University
- Investigators
- Peter Konrad, MD PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899858
- Sponsor's protocol ID
- 140503
- Acronym
- ISMS
- Status last verified
- Feb 2022
- First submitted
- 26 Aug 2016
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared with the DSMB when screening and recruiting subjects and when a subject exits the study
Publications
Mushahwar VK, Jacobs PL, Normann RA, Triolo RJ, Kleitman N. New functional electrical stimulation approaches to standing and walking. J Neural Eng. 2007 Sep;4(3):S181-97. doi: 10.1088/1741-2560/4/3/S05. Epub 2007 Aug 22.
PubMed 17873417Bamford JA, Mushahwar VK. Intraspinal microstimulation for the recovery of function following spinal cord injury. Prog Brain Res. 2011;194:227-39. doi: 10.1016/B978-0-444-53815-4.00004-2.
PubMed 21867807
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Standing and Walking With ISMS in Humans
- ClinicalTrials.gov ID
- NCT02899858
- Acronym / sponsor ID
- ISMS / 140503
- Conditions
- Spinal Cord Injury, Paralysis
- Keywords
- Thoracic spinal cord injury, Paralysis, ASIA A, Device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding stopped and no one met IRB approved enrollment criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- University of Alberta, Belmont University
- Study start
- Jan 2015 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 14 Sep 2016 (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.
Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to stand and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20 years, clinicians have tried to reengage such these circuits for standing and walking in the lower spinal cord of paralyzed humans through novel paradigms of physical therapy, pharmacological stimulation of the spinal cord, or recently - epidural stimulation of the spinal cord. Although standing and stepping with these maneuvers are rudimentary at best, these human studies offer promise to restore controlled, lower extremity movement to the spinal cord injured (SCI) individual. Evidence from animal data suggests that more focal activation of intraspinal circuitry (IntraSpinal Micro-Stimulation - ISMS) would produce more fatigue resistant, natural standing and stepping activity in humans. To date, there has been no direct confirmation of such circuitry in the spinal cord of bipedal humans who have been paralyzed. Furthermore, mapping of such circuitry would provide the basis of a novel intraspinal neuroprosthetic that should be able to restore control of standing or walking in a manner that is much more physiologically normal and tolerable than by stimulating each individual muscle group. Proof of the existence of these spinal circuits in man, and the ability to activate and control these circuits by first mapping the spinal cord is the basis of this proposal.
Detailed description
Two study volunteers who are completely paralyzed (T2-8 region) to undergo an evaluation of ISMS during an otherwise normal thoracic spinal surgical procedure.
The potential volunteers will be asked to review and sign a screening consent form prior to initial screening. This is to ensure that the ideal two patients are selected for this study and that foreseeable issues are identified and risks minimized for the volunteers. The subjects must have a stable, complete spinal cord injury involving their upper thoracic spinal cord (T2-8 region), and are otherwise planning to undergo a spine surgery involving the lower thoracic spinal cord.
Subjects who have volunteered for this study will undergo their intended spinal surgery by the clinical team. The usual indications for undergoing such a surgery is either to correct a deformity involving the lower thoracic region, or stabilizing the lower thoracic region due to chronic instability from degenerative disease. The surgery intended for clinical treatment must involve exposure of the T9-T12 spinal lamina. However, exposure of the spinal cord through a dural opening would not normally be performed in this clinical scenario. The experimental portion of the surgery begins then, with a laminectomy of T9-T12 and exposure of the spinal cord through a durotomy using standard neurosurgical techniques for spinal cord exposure. The spinal cord in this region will then be mapped and stimulated using ISMS and the effects on the legs measured to determine if the circuitry exists to potentially allow standing or walking through the use of ISMS. The research requests subjects to specifically allow 2 hours of extra time during the routine spinal surgery to perform this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IntraSpinal Micro-Stimulation | Experimental | Other: Movement Assessment, Other: MRI Scan, Procedure: IntraSpinal Micro-Stimulation, Other: Follow up clinical exam, Other: Post Op MRI Scan, Other: Follow up gait assessmentIntraSpinal Micro-Stimulation will be performed using a maximum of 16 electrodes inserted along each side of spinal cord that correlate with movements created across all 3 joints (hips, knees, and ankles) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 18-50 years old; male or female (no preference).
- Complete paraplegia (ASIA A classification) as a result of a spinal cord injury between the levels of T2-8.
- Patients with involuntary spasms are allowed. However, spasticity must be less than Ashworth 4 or spasm rating of 3 or less.
- History of spinal cord injury greater than 1 year.
- Intent to undergo spine surgery involving exposure of at least T9-T12 vertebral lamina.
Key exclusion criteria (13 listed)
- Acute medical conditions that are under active treatment. Examples include active urinary tract infection, respiratory illness, decubital ulcers, fractures, upper extremity injury, back pain.
- Pregnancy.
- Presence of a neurostimulator, bladder stimulator, cardiac stimulator or other electrical stimulator device implant.
- Inability to transfer from wheel chair to chair or bed.
- Inability to tolerate 1 hour of physical activity such as gait training in a harness.
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 |
|---|---|---|
| Movement AssessmentDocumentation of ASIA A (T2-8) status at Belmont Gait Lab | Other | IntraSpinal Micro-Stimulation |
| MRI ScanTotal MRI of spine to evaluate condition of spinal cord | Other | IntraSpinal Micro-Stimulation |
| IntraSpinal Micro-StimulationIntraSpinal Micro-Stimulation will be performed using a maximum of 16 electrodes inserted along each side of spinal cord that correlate with movements created across all 3 joints (hips, knees, and ankles) | Procedure or surgery | IntraSpinal Micro-Stimulation |
| Follow up clinical examAll subjects will be expected to return for a follow-up visit with Drs. Konrad at 1, 3 and 6 month follow up visits. | Other | IntraSpinal Micro-Stimulation |
| Post Op MRI ScanAn MRI will be obtained at 3 months following the procedure to document the impact of the mapping procedure on spinal cord anatomy. | Other | IntraSpinal Micro-Stimulation |
| Follow up gait assessmentFollow-up assessment with the Belmont Gait Lab will be performed at the 6 month follow up visit | Other | IntraSpinal Micro-Stimulation |
Primary outcome
IntraSpinal Micro-Stimulation
Time frame: 3 years
Movement of either or both lower extremities while the subject is anesthetized during routine spinal surgery will be performed.
1 secondary outcome
ISMS data collection:
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Background: PubMed 17873417Mushahwar VK, Jacobs PL, Normann RA, Triolo RJ, Kleitman N. New functional electrical stimulation approaches to standing and walking. J Neural Eng. 2007 Sep;4(3):S181-97. doi: 10.1088/1741-2560/4/3/S05. Epub 2007 Aug 22.
- Background: PubMed 21867807Bamford JA, Mushahwar VK. Intraspinal microstimulation for the recovery of function following spinal cord injury. Prog Brain Res. 2011;194:227-39. doi: 10.1016/B978-0-444-53815-4.00004-2.
- Individual participant dataSharing planned: Yes. Data will be shared with the DSMB when screening and recruiting subjects and when a subject exits the study
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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.
Peter Konrad, MD PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement Assessment, MRI Scan and IntraSpinal Micro-Stimulation in people with Spinal Cord Injury and Paralysis, run by Vanderbilt University 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 10 inclusion and 13 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: withdrawn, as of the sponsor's last update on 24 Feb 2022. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
IntraSpinal Micro-Stimulation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02899858, which also lists 2 linked publications.
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 Feb 2022.