Eccentric Muscle Training, Stimulation, and Biomarkers in SCI

December 16, 2025 updated by: Michele Basso, Ohio State University

Eccentric Motor Training With Neuromodulation and Biomarkers for Rehabilitation Readiness in Subacute SCI

The investigators are studying a new rehabilitation treatment for individuals trying to recover walking after spinal cord injury (SCI). The investigators will test conditions in the blood and spinal fluid to determine the best time to start this new training program. This will include checking for certain features called biomarkers by testing participants' spinal fluid and blood and compare these features to individuals without SCI. These features will help investigators determine when to start the new training program, either right away or waiting for 3 months. The new training program uses walking downhill on a slight slope on a treadmill while muscles that are not working normally are stimulated to contract using low levels of electricity. Adding this stimulation will allow people to practice walking and other skills even though full muscle control has not recovered. This new program will be in addition to any other rehabilitation therapy and will not replace standard rehabilitation. The hope is to see if downhill training with muscle stimulation, when delivered at the most ideal time, will improve trunk and leg movement, walking, and overall function. This recovery of movement and function will be compared to people with SCI receiving standard rehabilitation alone. Certain regions of the brain and spinal cord will also be studied using MRI scans to determine if these are affected by the training and compare to individuals without SCI. The total length of the study for SCI participants will be up to 16 weeks if in the standard of care group and up to 33 weeks if in the trained group. Healthy control participants will be involved for 1-2 visits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

SCI group: Individuals 3 months (+/-2 months) after SCI will be randomized into standard of care control group or augmented rehabilitation group (DownHill training with STIMulation = dhSTIM group). The study statistician will produce the randomization schedule with varying permuted blocks of size 3 and 6. The randomization schedule will be uploaded to REDCap for randomization of subjects at the time of enrollment into the study. The dhSTIM group will have cerebrospinal fluid (CSF) and blood collected and analyzed. These will be collected for research purposes only by the study's experienced proceduralist unless it is being collected clinically within the required timeframe for the study. CSF is collected via lumbar puncture under guided fluoroscopy which is a standardized technique to collect CSF and minimizes risks. If not enough CSF is collected on the first attempt, a second attempt may be required which is not expected due to the use of guided fluoroscopy but may occur in standard practice. Based on inflammatory status relative to healthy controls, the dhSTIM group will be directed to a Go group - immediate start at ~3 months) or No Go Group - delayed start at ~6 months. All SCI groups (dhSTIM Go, dhSTIM No Go, SOC) will also continue with regular outpatient therapy. The augmented rehabilitation groups and healthy controls will undergo MRI. The dhSTIM training will be a 12-week downhill training program combined with Xcite electrical stimulation 3 times a week. Participants will walk downhill on a treadmill with a harness for body weight support and trainers assisting as needed. All SCI groups (dhSTIM Go, dhSTIM No Go, SOC) will participate in pre, post, and 4 week follow-up assessments as follows: Biomechanical analysis will include kinematics, kinetics, and electromyography (EMG) while on the treadmill. Clinical outcome measures will include: American Spinal Injury Association (ASIA) Impairment scale (AIS), International standards for neurological classification of spinal cord injury (ISNCSCI), Autonomic Standards Assessment Form, Neuromuscular Recovery Scale, Neuropathic Pain Symptom Inventory, Pain Numeric Rating Scale, Spinal Cord Injury Independence Measure (SCIM3), 6 minute walk test (MWT), 10 meter walk test (MWT). Clinical outcome measures conducted as standard measures will be collected will be accessed via medical record when available. If absent from the medical record, they will be collected by a rater blind to group assignment. Leg strength will also be measured using the Biodex system. An additional MRI scan will be obtained at the end of the 12 week training period for the dhSTIM GO and dhSTIM No Go groups. Healthy Control Group: Healthy participants from the community will volunteer for the CSF and blood collection by the study's experienced proceduralist. CSF will be collected from at least half of the healthy controls prior to enrolling participants with SCI to provide a sample of normal levels of inflammatory genes and concentration of microglia-like cells as a baseline. CSF is collected for research purposes only via lumbar puncture under guided fluoroscopy which is a standardized technique to collect CSF and minimizes risks. If not enough CSF is collected on the first attempt, a second attempt may be required which is not expected due to the use of guided fluoroscopy but may occur in standard practice. When possible, they will also participate in one MRI scan of the brain and spinal cord. Due to MRI restrictions, some healthy controls may only be able to participate in biomarkers collection, some to only participate in MRI scans and some to participate in both types of collection. Individuals for the healthy control group will be enrolled until a total of n=10 +1 for biomarkers and n=10+1 for MRI is reached. One additional individual is allocated to account for dropouts. If there no individuals are able to take part in both MRI and fluid biomarker collection, then up to n=22 healthy controls will be enrolled.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Vancouver, Canada
        • Recruiting
        • University of British Columbia
        • Contact:
  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Michele Basso, EdD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

INCLUSION CRITERIA:

SCI participants WITHIN 1-5 MONTHS OF THEIR INJURY:

  • Discharged from inpatient rehabilitation;
  • AIS A-D at neurologic level C1-T10;
  • 18-85 years old.

Healthy controls:

  • Adults 18-85 years old;
  • no recent major musculoskeletal injury;
  • no recent surgery.

EXCLUSION CRITERIA:

SCI participants:

  • Use of botox in the past 3 months that reduces skeletal muscle function;
  • other neurologic conditions (i.e. brain injury, stroke, HIV);
  • current cancer diagnosis;
  • active deep vein thrombosis and anti-coagulation therapy;
  • skin wounds in regions that interfere with harness, stimulation pads or hand placement needed for training.
  • pregnancy;
  • ventilator-dependence;
  • cognitive conditions that preclude providing informed consent.
  • Implanted medical devices that are contraindicated for electrical stimulation or MRI *(If SCI participants have conditions contraindicated for MRI they may still participate in the remainder of study activities without myelin status as an outcome measure. SCI is a rare condition therefore this is necessary in order to achieve the required sample size.)

Healthy controls:

  • Implanted medical devices that are contraindicated for MRI (MRI participants only);
  • neurologic conditions (i.e. brain injury, stroke, HIV);
  • current cancer diagnosis;
  • clotting disorders requiring anti-coagulation therapy;
  • inflammatory conditions like arthritis, ulcerative colitis, lupus, etc;
  • pregnancy;
  • fear of needles;
  • claustrophobia;
  • cognitive conditions that preclude providing informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SCI Go
Participants with SCI randomized to the experimental group that have biomarkers that indicate low levels of inflammation will start immediately.
Other: Downhill Eccentric Treadmill Training with Electrical Stimulation
Participants will walk on a treadmill with a downward incline with support from a harness and assistance from trainers as needed. Participants will also simultaneously receive stimulation to their muscles including their trunk and legs. Each session will include 20 minutes of walking divided into 5 minute bouts with 5 minute rest breaks in between for 3 sessions per week for 12 weeks.
Experimental: SCI No Go
Participants with SCI randomized to the experimental group that have biomarkers that indicate high levels of inflammation will have a delayed start of 3 months.
Other: Downhill Eccentric Treadmill Training with Electrical Stimulation
Participants will walk on a treadmill with a downward incline with support from a harness and assistance from trainers as needed. Participants will also simultaneously receive stimulation to their muscles including their trunk and legs. Each session will include 20 minutes of walking divided into 5 minute bouts with 5 minute rest breaks in between for 3 sessions per week for 12 weeks.
No Intervention: SCI SOC
Participants with SCI randomized to the standard of care (SOC) group will continue with regular therapy.
No Intervention: Healthy Control
Healthy controls will provide biomarker and/or myelin (MRI) data

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in electromyography of eccentric acting muscles
Time Frame: 12 weeks
Muscle activation during weight acceptance while walking on a treadmill
12 weeks
Change from baseline in kinetics during weight acceptance
Time Frame: 12 weeks
Peak magnitude of loading response as measured by the peak magnitude of power absorption during the weight acceptance phase of walking on a treadmill
12 weeks
Change from baseline in kinematics during weight acceptance: hip range of motion
Time Frame: 12 weeks
Range of motion of the hip joint during walking on a treadmill
12 weeks
Change from baseline in kinematics during weight acceptance: knee range of motion
Time Frame: 12 weeks
Range of motion of the knee joint during walking on a treadmill
12 weeks
Change from baseline in kinematics during weight acceptance: ankle range of motion
Time Frame: 12 weeks
Range of motion of the ankle joint during walking on a treadmill
12 weeks
Change from baseline in kinematics during weight acceptance: hip acceleration
Time Frame: 12 weeks
Acceleration of the hip joint during walking on a treadmill
12 weeks
Change from baseline in kinematics during weight acceptance: knee acceleration
Time Frame: 12 weeks
Acceleration of the knee joint during walking on a treadmill
12 weeks
Change from baseline in kinematics during weight acceptance: ankle acceleration
Time Frame: 12 weeks
Acceleration of the ankle joint during walking on a treadmill
12 weeks
Change from baseline in myelination in brain and spinal cord measured by Magnetic Resonance Imaging (MRI)
Time Frame: 12 weeks
Myelin spared pre and post intervention in the motor areas of the brain and cervical spinal cord compared to healthy controls
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in ASIA Impairment Scale (AIS)
Time Frame: 12 weeks
Classification of injury using grades A, B, C, D or E indicating level of impairment including complete (A), sensory incomplete (B), or motor incomplete (C and D). A classification differences between C and D indicates if less or more than half (respectively) of myotomes below the level of injury are able to at least move through the full range of motion against gravity. A grade of E indicates normal sensory and strength function.
12 weeks
Change from 12 weeks to 16 weeks in American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Time Frame: 16 weeks
Classification of injury using grades A, B, C, D or E indicating level of impairment including complete (A), sensory incomplete (B), or motor incomplete (C and D). A classification differences between C and D indicates if less or more than half (respectively) of myotomes below the level of injury are able to at least move through the full range of motion against gravity. A grade of E indicates normal sensory and strength function.
16 weeks
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores
Time Frame: 12 weeks
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. Motor scores range from 0-50 for each the right and left sides and 50 for each the upper extremities and lower extremities. A higher score indicates better outcomes (strength).
12 weeks
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): motor scores
Time Frame: 16 weeks
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. Motor scores range from 0-50 for each the right and left sides and 50 for each the upper extremities and lower extremities. A higher score indicates better outcomes (strength).
16 weeks
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): sensory scores
Time Frame: 12 weeks
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. Sensory scores range from 0-112 for each the right and left sides. A higher score indicates better outcomes (sensation).
12 weeks
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): sensory scores
Time Frame: 16 weeks
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. Sensory scores range from 0-112 for each the right and left sides. A higher score indicates better outcomes (sensation).
16 weeks
Change from baseline in International Standards for Neurological Classification of SCI (ISNCSCI): neurological level of injury (NLI)
Time Frame: 12 weeks
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. NLI can range from the first level of the cervical spinal cord (C1) indicating tetraplegia (C1-thoracic, T1) to the final sacral level (S4-5) which would indicate paraplegia.
12 weeks
Change from 12 weeks to 16 weeks in International Standards for Neurological Classification of SCI (ISNCSCI): neurological level of injury (NLI)
Time Frame: 16 weeks
A universal classification tool for SCI based on a standardized sensory and motor assessment. The impairment scale involves both a motor and sensory examination to determine the sensory and motor levels for the right and left side, the overall neurological level of the injury and completeness of the injury i.e. whether the injury is complete or incomplete. NLI can range from the first level of the cervical spinal cord (C1) indicating tetraplegia (C1-thoracic, T1) to the final sacral level (S4-5) which would indicate paraplegia.
16 weeks
Change from baseline on Autonomic Standards Assessment Form
Time Frame: 12 weeks
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI). Patient self-reported responses include normal (2) when there is no change in neurological control with respect to a specific function; reduced or altered (1) neurological control with regard to a specific function; absent (0) neurological control with regard to a specific function; and unable to assess a specific function (not testable, NT).
12 weeks
Change from 12 weeks to 16 weeks on Autonomic Standards Assessment Form
Time Frame: 16 weeks
International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI). Patient self-reported responses include normal (2) when there is no change in neurological control with respect to a specific function; reduced or altered (1) neurological control with regard to a specific function; absent (0) neurological control with regard to a specific function; and unable to assess a specific function (not testable, NT).
16 weeks
Change from baseline on Neuromuscular Recovery Scale (NRS) score
Time Frame: 12 weeks
Measures quality of movement without compensation. Scored in phases 1-4 with subphases A-C, with scores indicating most impairment (1A, numeric value of 1-1.99) to least impairment (4C, numeric value of 12).
12 weeks
Change from 12 weeks to 16 weeks on Neuromuscular Recovery Scale (NRS) score
Time Frame: 16 weeks
Measures quality of movement without compensation. Scored in phases 1-4 with subphases A-C, with scores indicating most impairment (1A, numeric value of 1) to least impairment (4C, numeric value of 12).
16 weeks
Change from baseline in 6 Minute Walk Test (6MWT)
Time Frame: 12 weeks
The distance walked overground within 6 minutes (meters).
12 weeks
Change from 12 weeks to 16 weeks in 6 Minute Walk Test (6MWT)
Time Frame: 16 weeks
The distance walked overground within 6 minutes (meters).
16 weeks
Change from baseline in 10 Meter Walk Test
Time Frame: 12 weeks
Gait speed - the time it takes to walk 10 meters (seconds)
12 weeks
Change from 12 weeks to 16 weeks in 10 Meter Walk Test
Time Frame: 16 weeks
Gait speed - the time it takes to walk 10 meters (seconds)
16 weeks
Change from baseline in Spinal Cord Independence Measure III (SCIM3) score
Time Frame: 12 weeks
Assessment of various activities of daily living. Scoring ranges per category: Self-care subscale, Items 1-4 (0-20); Respiration and sphincter management subscale, Items 5-8 (0-40); Mobility subscale, Items 9-17 (0-40) with higher scores indicating more independence.
12 weeks
Change from 12 weeks to 16 weeks in Spinal Cord Independence Measure III (SCIM3) score
Time Frame: 16 weeks
Assessment of various activities of daily living. Scoring ranges per category: Self-care subscale, Items 1-4 (0-20); Respiration and sphincter management subscale, Items 5-8 (0-40); Mobility subscale, Items 9-17 (0-40) with higher scores indicating more independence.
16 weeks
Change from baseline in Neuropathic Pain Symptom Inventory (NPSI) scale
Time Frame: 12 weeks
Characterization of neuropathic pain symptom severity in 5 subscales (burning, pressing, paroxysmal, evoked, and paresthesia/dysesthesia. Each item is scored on a scale of 0 (indicating no pain) to 10 (worst pain imaginable). Each subscale is added then divided by 100, giving a total score ranging from 0-1 with scores closest to 1 indicating worse pain.
12 weeks
Change from 12 weeks to 16 weeks in Neuropathic Pain Symptom Inventory (NPSI) scale
Time Frame: 16 weeks
Characterization of neuropathic pain symptom severity in 5 subscales (burning, pressing, paroxysmal, evoked, and paresthesia/dysesthesia. Each item is scored on a scale of 0 (indicating no pain) to 10 (worst pain imaginable). Each subscale is added then divided by 100, giving a total score ranging from 0-1 with scores closest to 1 indicating worse pain.
16 weeks
Change from baseline in Numeric Pain Rating Scale (NPRS)
Time Frame: 12 weeks
Subjective measure of the intensity of pain on a scale if 0-10, with a higher score indicating worse pain.
12 weeks
Change from 12 weeks to 16 weeks in Numeric Pain Rating Scale (NPRS)
Time Frame: 16 weeks
Subjective measure of the intensity of pain on a scale if 0-10, with a higher score indicating worse pain.
16 weeks
Change from baseline in Strength Testing
Time Frame: 12 weeks
Maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect) measured by a Biodex.
12 weeks
Change from 12 weeks to 16 weeks in Strength Testing
Time Frame: 16 weeks
Maximum voluntary eccentric knee flexion contraction after performing eccentric activity on the contralateral limb (i.e., the contralateral priming effect) measured by a Biodex.
16 weeks
Change from baseline in electromyography of eccentric acting muscles at 12 weeks
Time Frame: 12 weeks
Muscle activation during weight acceptance while walking on a treadmill
12 weeks
Change from 12 weeks to 16 weeks in kinetics during weight acceptance
Time Frame: 16 weeks
Peak magnitude of loading response as measured by the peak magnitude of power absorption during the weight acceptance phase of walking on a treadmill
16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: hip range of motion
Time Frame: 16 weeks
Range of motion of the hip joint during walking on a treadmill
16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: knee range of motion
Time Frame: 16 weeks
Range of motion of the knee joint during walking on a treadmill
16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: ankle range of motion
Time Frame: 16 weeks
Range of motion of the ankle joint during walking on a treadmill
16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: hip acceleration
Time Frame: 16 weeks
Acceleration of the hip joint during walking on a treadmill
16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: knee acceleration
Time Frame: 16 weeks
Acceleration of the knee joint during walking on a treadmill
16 weeks
Change from 12 weeks to 16 weeks in kinematics during weight acceptance: ankle acceleration
Time Frame: 16 weeks
Acceleration of the ankle joint during walking on a treadmill
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of British Columbia
United States Department of Defense
University of Notre Dame

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: D. Michele Basso, EdD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021H0209
  • GRANT13192544 (Other Grant/Funding Number: United States Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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