Traumatic Thoracic Acute Spinal Cord InjuryNCT02138110
The INSPIRE Study: Probable Benefit of the Neuro-Spinal Scaffold for Treatment of AIS A Thoracic Acute Spinal Cord Injury
A study testing Neuro-Spinal Scaffold in people with Traumatic Thoracic Acute Spinal Cord Injury, run by InVivo Therapeutics at 8 sites in United States.
Trial summary
This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Traumatic Thoracic Acute Spinal Cord Injury
- What is being tested?
- Neuro-Spinal Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesUnited States
- Study dates
- 13 Oct 2014to Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must meet all of the following to be considered eligible:
- AIS A classification of traumatic spinal cord injury at T2-T12 neurological level of injury confirmed by a qualified medical professional
- Recent injury (must receive Scaffold within 7 days from injury)
- Non-penetrating SCI (contusion injury) that is no less than approximately 4 mm in diameter by MRI
- Requires open spine surgery allowing access to the injured spinal cord (subjects requiring either posterior surgical approach or posterior plus anterior approach will be eligible)
- Informed consent obtained
- 16-70 years of age, inclusive
- Hemodynamically stable and deemed a suitable candidate for surgery
Who cannot join
- Subjects who meet any of the following will be excluded:
- Terminally ill subjects not likely to be able to participate in follow-up
- Incomplete spinal cord injury (AIS B, C, D, and E injuries)
- Subjects with more than one discrete spinal cord injury (contusion) will be excluded.
- No discrete cavity (existing or created by irrigation/myelotomy) in the contused spinal cord in which a Scaffold can be placed
- Evidence of clear and significant Somatosensory Evoked Potentials (SSEP) transmission through the injury site before Scaffold implantation (based on the judgment of the Investigator)
Show all 27Show fewer
- Subjects with clinically significant pre-existing neurological comorbidities that are unrelated to the contusion being treated (e.g., multiple sclerosis, amyotrophic lateral sclerosis, significant prior peripheral nerve dysfunction, residual problems related to previous spine-related neurological pathologies) will be excluded only if it is felt that these preexisting morbidities will increase risk, affect safety monitoring, or confound study results
- Spinal cord injury associated with significant traumatic brain injury or coma that, in the opinion of the Investigator, would preclude adequate assessment of spinal cord function, brain injury that could be associated on its own with sensory or motor deficits, or subjects with any other reason that results in an unreliable International Standards of Neurological Classification of Spinal Cord Injury (ISNCSCI) exam
- Subjects with clinically significant pre-existing respiratory disease not related to the contusion being treated (e.g., chronic obstructive pulmonary disorder)
- Subjects requiring Long-term ongoing mechanical ventilation
- Subjects with documented immune deficiency disorders, including a known diagnosis of HIV infection/AIDS
- Recent (according to Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or DSM V criteria) history of abuse of narcotics or other significant substance abuse
- Significant injury complications where, in the view of the Investigator, participation in the study could further complicate subject care, limit study follow-up, or confound interpretation of safety or efficacy data.
- A female who is:
- Pregnant, or planning to become pregnant within the next 12-months; or
- Breastfeeding; or
- A woman of child-bearing potential (defined as post menarche and biologically capable of becoming pregnant [i.e., not surgically sterile]) who is engaged in active heterosexual relations and is not willing to use a barrier or hormonal form of birth control for 12-months following Scaffold implantation (e.g., oral, injected, or implanted contraceptives)
- A male who is engaged in active heterosexual relations and is not willing to use birth control for 3-months following Scaffold implantation including sperm donation or banking
- Current or impending incarceration
- Complete spinal cord transection
- Subjects with spinal cord injuries directly due to gunshot, knife, or other penetrating wounds.
- Known hypersensitivity to poly(lactic-co-glycolic acid) (PLGA) or poly-L-lysine (PLL) (e.g., hypersensitivity to absorbable sutures containing PLGA)
- History of severe mental illness (according to DSM IV or V)
- Evidence of pre-trauma active local or systemic infection
- Participation in another interventional clinical trial for six months after Scaffold implantation
- Body mass index (BMI) over 39
- Having a medical condition (e.g., cardiovascular disease, life threatening injuries), or receiving medical treatment, or having any other reason that, in the judgment of the Investigator, precludes successful participation and follow-up for at least six months or confounds collection or interpretation of study safety, feasibility, or efficacy data
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Cooper Neurological Institute
Camden, New Jersey, 08103
Carolina NeuroSurgery and Spine Associates/Carolinas Rehabilitation
Charlotte, North Carolina, 28204
Vidant Medical Center
Greenville, North Carolina, 27834
USC/Keck School of Medicine
Los Angeles, California, 90033
Barrow Neurological Institute - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Oregon Health & Science University
Portland, Oregon, 97239
University of California/Davis Medical Center
Sacramento, California, 95816
About this study
Official title: The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold(TM) for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A Spinal Cord Injury
This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12.
Read the detailed description
This is an HDE probable benefit, open-label, non-randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12.
The study will be conducted by qualified Investigators who have been trained on the surgical Scaffold implant procedure in order to enroll subjects in the Primary Endpoint Analysis Set, defined as all subjects with a successful Scaffold implant, no major protocol deviations, and a complete 6-month Primary Endpoint Follow-up Visit. After receiving the Scaffold and following discharge, subjects will participate in a comprehensive rehabilitation program. For the first 24-months after implantation of the Scaffold, Follow-up and Long-term Follow-up assessments will be conducted at either the study site or the rehabilitation center. The Long-term Follow-up annual visits for years 3 through 10 will be conducted over the telephone.
- Being tested
- Neuro-Spinal Scaffold
- Keywords
- Spinal Cord Injury (SCI), Complete (AIS A) Traumatic Acute Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-Spinal ScaffoldDevice
Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
| Study group | Role | What they receive |
|---|---|---|
| Neuro-Spinal Scaffold | Experimental | Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery Receives: Device: Neuro-Spinal Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Improvement in AIS Grade of One or More Levels
The ASIA (American Spinal Injury Association) Impairment Scale (AIS) classifies spinal cord injuries as follows:
A = Complete: no sensory or motor function is preserved in the sacral segments S4-S5
B = Sensory incomplete: sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5, AND no motor function is preserved more than three levels below the motor level on either side of the body
C = Motor incomplete: motor function is preserved below the neurological level, and more than half of key muscle functions below the single neurological level of injury have a muscle grade less than 3 (Grades 0-2)
D = Motor incomplete: at least half (half or more) of key muscle functions below the NLI have a muscle grade >3
E = Normal
The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
Measured: 6 months post-implantation
Secondary outcomes (6)
Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months
The neurological level of injury (NLI) refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally.
A caudal change is an improvement in NLI whereas a rostral change is a deterioration in NLI.
The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
Measured: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Pin Prick Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function.
The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
An improvement in pin prick score indicates an increase in score from baseline at 6-months A deterioration in pin prick score indicates a decrease in score from baseline at 6-months No change in pin prick score indicates no change in score from baseline at 6-months
Measured: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Light Touch Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function.
The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
An improvement in light touch score indicates an increase in light touch score from baseline at 6-months A deterioration in light touch score indicates a decrease in light touch score from baseline at 6-months No change in light touch score indicates no change in light touch score from baseline at 6-months
Measured: 6 months post-implantation
Change From Baseline in ISNCSCI Total Motor Score
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Total Motor Scores were assessed on a scale from 0 to 5 for each myotome tested on each side of the body (upper limb maximum score = 50 and lower limb maximum score = 50), with higher scores indicating better neurologic function.
The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
An improvement in motor score indicates an increase in motor score from baseline at 6-months A deterioration in motor score indicates an decrease in motor score from baseline at 6-months No change in motor score indicates no change in motor score from baseline at 6-months
Measured: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence)
Characteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including presence or absence of intraparenchymal cysts.
Screening MRI was used as the baseline value.
Measured: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence)
Characteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including the presence or absence of spinal cord adhesion.
Screening MRI was used as the baseline value.
Measured: 6 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study start13 Oct 2014
- Primary completion29 Nov 2017
- Study completionDec 2023
Why it stopped: Primary Endpoint not met in follow-up study (InVivo-100-105)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Thoracic Acute 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- InVivo Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Toselli, MD, Study director, InVivo Therapeutics Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138110
- Sponsor's protocol ID
- InVivo-100-101
- Status last verified
- Jan 2024
- First submitted
- 1 May 2014
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Harrop JS, Kim KD, Okonkwo DO, Goldstein IM, Lee KS, Toselli RM. Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: A Randomized Controlled Trial (INSPIRE 2.0). Neurosurgery. 2025 Apr 1;96(4):751-762. doi: 10.1227/neu.0000000000003180. Epub 2024 Oct 8.
PubMed 39471088Kim KD, Lee KS, Coric D, Harrop JS, Theodore N, Toselli RM. Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study. Neurosurgery. 2022 Jun 1;90(6):668-675. doi: 10.1227/neu.0000000000001932. Epub 2022 Apr 22.
PubMed 35442254Kim KD, Lee KS, Coric D, Chang JJ, Harrop JS, Theodore N, Toselli RM. A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study. J Neurosurg Spine. 2021 Feb 5;34(5):808-817. doi: 10.3171/2020.8.SPINE191507. Print 2021 May 1.
PubMed 33545674Theodore N, Hlubek R, Danielson J, Neff K, Vaickus L, Ulich TR, Ropper AE. First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility. Neurosurgery. 2016 Aug;79(2):E305-12. doi: 10.1227/NEU.0000000000001283.
PubMed 27309344
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold(TM) for Safety and Neurologic Recovery in Subjects With Complete Thoracic AIS A Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02138110
- Acronym / sponsor ID
- InVivo-100-101
- Keywords
- Spinal Cord Injury (SCI), Complete (AIS A) Traumatic Acute Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary Endpoint not met in follow-up study (InVivo-100-105)
- Enrolment
- 20 participants (actual)
- Lead sponsor
- InVivo TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2014 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Posted 28 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an HDE probable benefit, open-label, non- randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12.
Detailed description
This is an HDE probable benefit, open-label, non-randomized, single-arm, multicenter study to evaluate the safety and probable benefit of the poly(lactic-co-glycolic acid)-b-poly(L-lysine) Scaffold ("Scaffold") in subjects with thoracic AIS A traumatic spinal cord injury at neurological level of injury of T2-T12.
The study will be conducted by qualified Investigators who have been trained on the surgical Scaffold implant procedure in order to enroll subjects in the Primary Endpoint Analysis Set, defined as all subjects with a successful Scaffold implant, no major protocol deviations, and a complete 6-month Primary Endpoint Follow-up Visit. After receiving the Scaffold and following discharge, subjects will participate in a comprehensive rehabilitation program. For the first 24-months after implantation of the Scaffold, Follow-up and Long-term Follow-up assessments will be conducted at either the study site or the rehabilitation center. The Long-term Follow-up annual visits for years 3 through 10 will be conducted over the telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuro-Spinal Scaffold | Experimental | Device: Neuro-Spinal ScaffoldImplantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- AIS A classification of traumatic spinal cord injury at T2-T12 neurological level of injury confirmed by a qualified medical professional
- Recent injury (must receive Scaffold within 7 days from injury)
- Non-penetrating SCI (contusion injury) that is no less than approximately 4 mm in diameter by MRI
- Requires open spine surgery allowing access to the injured spinal cord (subjects requiring either posterior surgical approach or posterior plus anterior approach will be eligible)
- Informed consent obtained
Key exclusion criteria (27 listed)
- Terminally ill subjects not likely to be able to participate in follow-up
- Incomplete spinal cord injury (AIS B, C, D, and E injuries)
- Subjects with more than one discrete spinal cord injury (contusion) will be excluded.
- No discrete cavity (existing or created by irrigation/myelotomy) in the contused spinal cord in which a Scaffold can be placed
- Evidence of clear and significant Somatosensory Evoked Potentials (SSEP) transmission through the injury site before Scaffold implantation (based on the judgment of the Investigator)
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 |
|---|---|---|
| Neuro-Spinal ScaffoldImplantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery | Device | Neuro-Spinal Scaffold |
Primary outcome
Percentage of Patients With Improvement in AIS Grade of One or More Levels
Time frame: 6 months post-implantation
The ASIA (American Spinal Injury Association) Impairment Scale (AIS) classifies spinal cord injuries as follows: A = Complete: no sensory or motor function is preserved in the sacral segments S4-S5 B = Sensory incomplete: sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5, AND no motor function is preserved more than three levels below the motor level on either side of the body C = Motor incomplete: motor function is preserved below the neurological level, and more than half of key muscle functions below the single neurological level of injury have a muscle grade less than 3 (Grades 0-2) D = Motor incomplete: at least half (half or more) of key muscle functions below the NLI have a muscle grade >3 E = Normal The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.
6 secondary outcomes
Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months
Time frame: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score
Time frame: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score
Time frame: 6 months post-implantation
Change From Baseline in ISNCSCI Total Motor Score
Time frame: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence)
Time frame: 6 months post-implantation
Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence)
Time frame: 6 months post-implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39471088Harrop JS, Kim KD, Okonkwo DO, Goldstein IM, Lee KS, Toselli RM. Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: A Randomized Controlled Trial (INSPIRE 2.0). Neurosurgery. 2025 Apr 1;96(4):751-762. doi: 10.1227/neu.0000000000003180. Epub 2024 Oct 8.
- Derived from this study: PubMed 35442254Kim KD, Lee KS, Coric D, Harrop JS, Theodore N, Toselli RM. Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study. Neurosurgery. 2022 Jun 1;90(6):668-675. doi: 10.1227/neu.0000000000001932. Epub 2022 Apr 22.
- Derived from this study: PubMed 33545674Kim KD, Lee KS, Coric D, Chang JJ, Harrop JS, Theodore N, Toselli RM. A study of probable benefit of a bioresorbable polymer scaffold for safety and neurological recovery in patients with complete thoracic spinal cord injury: 6-month results from the INSPIRE study. J Neurosurg Spine. 2021 Feb 5;34(5):808-817. doi: 10.3171/2020.8.SPINE191507. Print 2021 May 1.
- Derived from this study: PubMed 27309344Theodore N, Hlubek R, Danielson J, Neff K, Vaickus L, Ulich TR, Ropper AE. First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility. Neurosurgery. 2016 Aug;79(2):E305-12. doi: 10.1227/NEU.0000000000001283.
- Individual participant dataSharing planned: No
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.
Richard Toselli, MD study director
InVivo Therapeutics Corporation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-Spinal Scaffold in people with Traumatic Thoracic Acute Spinal Cord Injury, run by InVivo Therapeutics at 8 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 8 inclusion and 27 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: stopped early, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 28 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients With Improvement in AIS Grade of One or More Levels (time frame: 6 months post-implantation). 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 NCT02138110, which also lists 4 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 17 Jan 2024.