SCI - Spinal Cord InjurySCI-AFOSNCT06351111
Vagus Nerve Stimulation (VNS) in Spinal Cord Injury (SCI) Adaptive Follow-On Study
A study testing Active VNS in people with SCI - Spinal Cord Injury, run by The University of Texas at Dallas at 2 sites in United States.
Trial summary
This study is an open label extension of the SCI EFS clinical trial (NCT04288245) that developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Active VNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Aug 2024to May 2028
- Phase
- Interventional
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
General Inclusion Criteria:
- Completed phase 2 of the SCI EFS study (NCT04288245)
- Willing to comply with procedures for the entire duration of the study (study protocol compliance)
- Provision of signed and dated informed consent form
- Access to reliable communication and internet connections (for those intending to complete sessions at home)
- Has not had their VNS device explanted
General Exclusion Criteria:
- Concurrent participation in another active interventional trial or participation in an active interventional trial within 7 days prior to enrollment
- Any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator
- Any condition which would preclude adequate evaluation of device's safety and performance in the judgment of the Investigator
- Individuals who have a change in medical condition or health status such that they would meet the exclusion criteria of the EFS
- Concomitant clinically significant brain injuries
- Receiving any other therapy that would interfere with VNS
- Females of childbearing potential who are either pregnant, lactating, heterosexually active, or planning to become pregnant or heterosexually active during study participation; and who are not using, or will not agree to use medically acceptable birth control methods
- Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere with study participation, as assessed by medical evaluation
- Participants with a current or past: (i) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability; or (ii) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation:
- May pose a significant or undue risk to the person;
- Make it unlikely the person will complete all the study requirements per protocol; or
- May adversely impact the integrity of the data or the validity of the study results
- Participants with active neoplastic disease.
- Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema, and clinically-significant hypotension or bradycardia).
- Participants with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
- Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
- Aphasia and other cognitive deficits may be present but participants will be excluded if are unable to understand the potential risks and benefits of the study or personally provide informed consent.
- A recent history of syncope
- A recent history of dysphagia
- Currently require, or are likely to require diathermy
- Significant respiratory issues that would interfere with participation
- Non-English speaking
- Patients who are acutely suicidal and/or have been admitted for a suicide attempt
- As determined by the principal investigator, is under current incarceration or legal detention
Track Specific Inclusion Criteria:
Upper Limb (UL):
1)None
Lower Limb (LL):
1)Ambulatory with gait impairment
Bladder Control (BC):
1)Issues with urinary function arising from SCI, with partial voluntary initiation of voiding 2)Intermittent catheterization for bladder management
Sensory (SY):
1)Impairment in sensory function, based on the baseline assessments below:
- US-NSA score <92 points
- Two-point discrimination fingertip score >5mm
- Two-point discrimination palm score >15mm
- Tactile Discrimination Test score <16points
- Semmes-Weinstein Monofilaments score >3.61g Track Specific Exclusion Criteria: Upper Limb (UL): 1)None Lower Limb (LL): 1)None Bladder Control (BC): 1)Indwelling catheter use 2)Participants with a history of severe or recurrent autonomic dysreflexia 3)Technical limitations that would preclude bladder ultrasonography assessments 4)Medical history that would preclude adequate evaluation of urologic outcomes Sensory (SY):
- Pain that would impede study participation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Baylor University Medical Center
Dallas, Texas, 75246
Texas Biomedical Device Center
Richardson, Texas, 75080
About this study
This study is an open label extension of the SCI EFS clinical trial (NCT04288245) that developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury. The objectives of this study are to provide continued safety assessment for the investigational ReStore system, and to gain further estimate of the effect of Vagus Nerve Stimulation (VNS) with rehabilitative exercises in four different tracks - upper limb (UL), lower limb (LL), bladder control (BC), and sensory (SY) for participants with chronic SCI (Spinal Cord Injury).
Read the detailed description
A prospective, multi-center, non-randomized, open label extension of the SCI EFS trial (NCT04288245) participants implanted with the investigational ReStore Device for VNS Therapy. Following the completion of Phase 2 of the SCI EFS study, participants can enroll to one of the four tracks. Under each track, participants will undergo up to 36 sessions of rehabilitative exercises self-paced by participants with targeted completion of 3 sessions per week. Evaluations will be administered at the beginning and end of each track (additional progress checks may be conducted, as required by the staff) to monitor participant progress. Upon completion of a track, participants can choose to re-enroll in the same or a different track. Adverse events will be documented and assessed throughout the trial.
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- Active VNS
- Keywords
- SCI - Spinal Cord Injury, VNS - Vagus Nerve Stimulation, TPT - Targeted Plasticity Therapy
- 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.
Active VNSDevice
Subjects will receive active VNS paired with track-specific rehabilitation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Upper limb (UL) | Experimental | Participants in this arm will receive up to 36 sessions of VNS paired with upper limb rehabilitative exercises Receives: Device: Active VNS |
| Lower limb (LL) | Experimental | Participants in this arm will receive up to 36 sessions of VNS paired with lower limb rehabilitative exercises Receives: Device: Active VNS |
| Bladder control (BC) | Experimental | Participants in this arm will receive up to 36 sessions of VNS paired with bladder control rehabilitative exercises Receives: Device: Active VNS |
| Sensory (SY) | Experimental | Participants in this arm will receive up to 36 sessions of VNS paired with sensory rehabilitative exercises Receives: Device: Active VNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (device safety)
UL, LL, BC and SY - Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore System
Measured: Starting at session 1 on week 1, throughout the study up to last session 36 on week 15.
Secondary outcomes (19)
Jebsen-Taylor Hand Function (JTHF) Score
UL only - Determine whether VNS therapy improves Jebsen-Taylor Hand Function (JTHF) score compared to baseline. This measure is not a scale. Each item is timed from 0 to 120 seconds. Lower/faster values are better.
Measured: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)
UL only - Determine whether VNS therapy improves the GRASSP score compared to baseline. This scale is from 0 to 116 points. Higher scores are better.
Measured: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Force & Range of motion
UL only - Determine whether VNS therapy improves force and range of motion in the hand and wrist compared to baseline.
Measured: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
6 Meter Walk Test (6MWT)
LL only - Determine whether VNS therapy improves six-minute walking test (6MWT) score compared to baseline. This measure is not a scale. Higher distance covered is better.
Measured: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
10 Meter Walk Test (10MWT)
LL only - Determine whether VNS therapy improves 10-Meter Walk Test (10-MWT) score compared to baseline. This measure is not a scale. Lower time to complete is better.
Measured: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Walking Index for Spinal Cord Injury II (WISCI II)
LL only - Determine whether VNS therapy improves Walking Index for Spinal Cord Injury II (WISCI II) score compared to baseline. This scale is from 0-20. Higher scores are better.
Measured: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Berg's Balance Scale (BBG)
LL only - Determine whether VNS therapy improves Berg's Balance Scale (BBG) score compared to baseline. This scale is from 0 to 56. Higher scores are better.
Measured: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Timed Up-and Go (TUG)Test
LL only - Determine whether VNS therapy improves Timed Up-and Go (TUG)Test score compared to baseline. This measure is not a scale. Lower time to complete is better.
Measured: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Lower Extremity Motor Score (LEMS)
LL only - Determine whether VNS therapy improves Lower Extremity Motor Score (LEMS) compared to baseline. This scale is from 0 to 50. Higher scores are better.
Measured: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Voiding efficiency
BC only - Estimate the shift in voiding efficiency through bladder ultrasonography assessment following active VNS
Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Bladder volume capacity
BC only - Estimate the shift in bladder volume capacity during bladder ultrasonography assessment following active VNS
Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Postvoid residual volume (PVR)
BC only - Estimate the shift in PVR during bladder ultrasonography assessment following active VNS
Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Neurogenic Bladder Symptom Score (NBSS) questionnaire
BC only - Estimate the shift in NBSS score following active VNS. This scale is from 0 to 78. Lower scores are better.
Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Urinary Distress Inventory (UDI-6), short form questionnaire
BC only - Estimate the shift in the UDI-6 questionnaire score following active VNS. This scale is from 0 to 18. Lower scores are better.
Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Two - Point Discrimination
SY only - Determine whether VNS therapy improves Two-Point Discrimination (2PD) score compared to baseline. This measure is not a scale but the ability to feel two separate points of touch on the skin instead of just one. It's a sensory test used in neurological exams to assess the density and health of nerve innervation in a specific area of the body. The test involves determining the smallest distance between two points that a person can still perceive as two separate stimuli.
Measured: At session 1 on week 1, on week 8, week 12 and as needed during intervening sessions from week 2 to 7.
Tactile Discrimination Test (TDT)
SY only- Determine whether VNS therapy improves Tactile Discrimination Test (TDT) score compared to baseline. This scale is from 0 to 25 points. Higher scores are better.
Measured: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.
Semmes-Weinstein Monofilaments (SWM)
SY only - Determine whether VNS therapy improves Semmes-Weinstein Monofilaments (SWM) test score compared to baseline. This measure is not a scale but a test to assess a person's light touch sensation using a set of filaments of different thickness to identify loss of protective sensation in areas like feet or hands. The level of the filament required to elicit a response provides a measurement of the patient's sensory threshold. Thinner filament indicates better sensory function.
Measured: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.
US-Nottingham Sensory Assessment (US-NSA)
SY only - Determine whether VNS therapy improves US-Nottingham Sensory Assessment (US-NSA) score compared to baseline. This assessment is a scale ranging from 0 to 92 for the upper extremity, and 0 to 172 for the combined upper and lower extremities. Higher scores indicate better sensory function.
Measured: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.
International SCI Pain Basic Data
SY only- Determine whether VNS therapy can reduce pain severity and improve patient-reported outcomes of the International SCI Pain Basic Data Set, compared to baseline measures. This measure uses a numeric rating scale from 0 to 10, where 0 indicates no pain. Lower scores indicate lower pain intensity.
Measured: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start29 Aug 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - 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
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a non-randomized, open-label, adaptive, optional extension study model
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Seth Hays, The University of Texas at Dallas
- Investigators
- Jane Wigginton, Principal investigator, The University of Texas at DallasRobert Rennaker, Principal investigator, The University of Texas at DallasRita Hamilton, Principal investigator, Baylor Scott and White Institute for Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351111
- Sponsor's protocol ID
- IRB-24-240
- Other IDs
- UG3NS131971
- Acronym
- SCI-AFOS
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation (VNS) in Spinal Cord Injury (SCI) Adaptive Follow-On Study
- ClinicalTrials.gov ID
- NCT06351111
- Acronym / sponsor ID
- SCI-AFOS / IRB-24-240
- Conditions
- SCI - Spinal Cord Injury
- Keywords
- SCI - Spinal Cord Injury, VNS - Vagus Nerve Stimulation, TPT - Targeted Plasticity Therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 8 Apr 2024 (actual)
- 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 an open label extension of the SCI EFS clinical trial (NCT04288245) that developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury. The objectives of this study are to provide continued safety assessment for the investigational ReStore system, and to gain further estimate of the effect of Vagus Nerve Stimulation (VNS) with rehabilitative exercises in four different tracks - upper limb (UL), lower limb (LL), bladder control (BC), and sensory (SY) for participants with chronic SCI (Spinal Cord Injury).
Detailed description
A prospective, multi-center, non-randomized, open label extension of the SCI EFS trial (NCT04288245) participants implanted with the investigational ReStore Device for VNS Therapy. Following the completion of Phase 2 of the SCI EFS study, participants can enroll to one of the four tracks. Under each track, participants will undergo up to 36 sessions of rehabilitative exercises self-paced by participants with targeted completion of 3 sessions per week. Evaluations will be administered at the beginning and end of each track (additional progress checks may be conducted, as required by the staff) to monitor participant progress. Upon completion of a track, participants can choose to re-enroll in the same or a different track. Adverse events will be documented and assessed throughout the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a non-randomized, open-label, adaptive, optional extension study model
| Arm | Type | Receives |
|---|---|---|
| Upper limb (UL) | Experimental | Device: Active VNSParticipants in this arm will receive up to 36 sessions of VNS paired with upper limb rehabilitative exercises |
| Lower limb (LL) | Experimental | Device: Active VNSParticipants in this arm will receive up to 36 sessions of VNS paired with lower limb rehabilitative exercises |
| Bladder control (BC) | Experimental | Device: Active VNSParticipants in this arm will receive up to 36 sessions of VNS paired with bladder control rehabilitative exercises |
| Sensory (SY) | Experimental | Device: Active VNSParticipants in this arm will receive up to 36 sessions of VNS paired with sensory rehabilitative exercises |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Active VNSSubjects will receive active VNS paired with track-specific rehabilitation exercises. | Device | Bladder control (BC), Lower limb (LL), Sensory (SY), Upper limb (UL) |
Primary outcome
Incidence of adverse events (device safety)
Time frame: Starting at session 1 on week 1, throughout the study up to last session 36 on week 15.
UL, LL, BC and SY - Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore System
19 secondary outcomes
Jebsen-Taylor Hand Function (JTHF) Score
Time frame: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)
Time frame: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Force & Range of motion
Time frame: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
6 Meter Walk Test (6MWT)
Time frame: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
10 Meter Walk Test (10MWT)
Time frame: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Berg's Balance Scale (BBG)
Time frame: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Timed Up-and Go (TUG)Test
Time frame: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Lower Extremity Motor Score (LEMS)
Time frame: At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.
Voiding efficiency
Time frame: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Bladder volume capacity
Time frame: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Postvoid residual volume (PVR)
Time frame: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Neurogenic Bladder Symptom Score (NBSS) questionnaire
Time frame: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Urinary Distress Inventory (UDI-6), short form questionnaire
Time frame: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.
Two - Point Discrimination
Time frame: At session 1 on week 1, on week 8, week 12 and as needed during intervening sessions from week 2 to 7.
Tactile Discrimination Test (TDT)
Time frame: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.
Semmes-Weinstein Monofilaments (SWM)
Time frame: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.
US-Nottingham Sensory Assessment (US-NSA)
Time frame: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.
International SCI Pain Basic Data
Time frame: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.
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 4 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for SCI - Spinal Cord Injury
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
Jane Wigginton principal investigator
The University of Texas at Dallas
Robert Rennaker principal investigator
The University of Texas at Dallas
Rita Hamilton principal investigator
Baylor Scott and White Institute for Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active VNS in people with SCI - Spinal Cord Injury, run by The University of Texas at Dallas 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?
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: enrolling by invitation, as of the sponsor's last update on 4 Jun 2026. 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?
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?
Incidence of adverse events (device safety) (time frame: Starting at session 1 on week 1, throughout the study up to last session 36 on week 15.). 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 4 Jun 2026.