Traumatic Brain InjuryGZNTNCT02509689
Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers
A study testing Global Z-Score Neurofeedback Training in people with Traumatic Brain Injury, run by The Defense and Veterans Brain Injury Center at 1 site in United States.
Trial summary
A new technology called Global Z-Score Neurofeedback Technology (GZNT) has been identified that can overcome an existing barrier to the use of neurofeedback as a treatment technique in a military setting. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Global Z-Score Neurofeedback Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Mar 2022
- 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
- Mild to Moderate Traumatic brain injury patients at least three months and not more than 5 years post-injury with recovery to a Rancho los Amigos level of seven or eight (alert and oriented);
- Brain injury documented in the medical record by a history of an injury event and at least one of the following:
- loss of consciousness of any duration after the injury event;
- post-traumatic amnesia after the injury event;
- alteration in mental status (dazed/confused) after the injury event;
- physical evidence of brain trauma (MRI/CT hemorrhage/contusion);
Show all 10Show fewer
- Persistent symptoms thought to be related to or co morbid with the brain injury event, to include two or more complaints related to problems with attention, memory, concentration, speed of processing, judgment, executive control, depression, anxiety, agitation, irritability, impulsivity, or aggression, headaches, and sleep disturbance;
- Evidence of emotional problems as defined by scores on the Post-Traumatic Stress Disorder Checklist, Military version (PCL-M) of 33 or more, or 9 or more on the Patient Health Questionnaire (PHQ-9);
- Military or Veteran beneficiary;
- Males and females aged 18-50.
Who cannot join
- Current/prior (last six months) unstable medical or psychiatric condition that could confound the effect of the TBI event on brain function (e.g. clear anoxic episode, cardiac arrest, current uncontrolled diabetes, psychosis)
- A previous history of severe TBI prior to the current injury;
- Current (last three months) active suicidal or homicidal ideation or intent;
- Current (last month) drug/alcohol abuse or dependence as determined by clinical assessment in addition to the AUDIT-C screening tool. Patients with problem drinking as defined by a score of 6 or higher on the AUDIT-C will not be eligible to participate due to concerns regarding the neurotoxic effects of alcohol following TBI. Those with scores of 4 or 5 will be counseled to reduce their intake of alcohol during the time course of the study, and a clinical determination will be made by the PI or Sub-I as to whether they can be included in the study.
- Use of certain medications due to potential interference with assessments and treatment response: benzodiazepines - excluded; narcotic analgesics - allowed only if occasional use, and not within 24 hrs of any evaluation or treatment session; nootropic medications - excluded.
- Participation in a concurrent drug or treatment trial;
- Any physical impairment that prevents the patient from being able to complete the assessment or treatment tasks (including sensory functions) or failure on effort measures at baseline evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Warrior Recovery Center, Bldg 1040
Fort Carson, Colorado, 80913
About this study
Official title: Feasibility Study of a Novel Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers
A new technology called Global Z-Score Neurofeedback Technology (GZNT) has been identified that can overcome an existing barrier to the use of neurofeedback as a treatment technique in a military setting. Neurofeedback, or EEG Biofeedback, is a form of biofeedback that uses the brain's own electrical activity as the training parameter. With sufficient practice, the brain can learn to change its own activity through finely tuned feedback using computerized sounds, graphs and animations. Previous attempts at using neurofeedback as a treatment modality have been subject to a lack of standardization and have required significant expertise on the part of the provider. This new GZNT technology allows neurofeedback to be administered in a standardized and semi-automated fashion, which, if effective, will represent a significant advance toward providing this promising treatment modality to Service Members in a military or VA setting. This study will determine feasibility and preliminary evidence of efficacy for this neurofeedback technology in a pilot study of soldiers with medical issues associated with Traumatic Brain Injury (TBI). GZNT technology has the potential to provide a cost-efficient, non-invasive/non-pharmacological approach to recovery from impact and/or blast-induced brain injury, and holds promise to simultaneously address emotional symptoms that are often a part of the post-concussion symptom picture.
Read the detailed description
Research Design: This will be a single group design, treatment effect and feasibility study to demonstrate GZNT technology, examining electrocortical changes, and comparing emotional/vocational functioning, and post concussive symptoms before and after intensive GZNT treatment, and at three months follow-up. Up to 50 subjects with a history of traumatic brain injury and persistent cognitive and emotional symptoms will be enrolled following screening and baseline evaluation. Resting and event-related EEG (electroencephalograph) recordings, a physiological stress evaluation, neuropsychological tests, self-report symptom scales, and psychosocial/vocational functioning measures will be performed at each evaluation. All subjects will receive the study treatment intervention. Subjects will be scheduled to receive twenty treatment sessions of GZNT over a six week period, but will be counted as having completed treatment if they attend fifteen or more sessions. At least twenty-five subjects will need to complete treatment to meet statistical requirements for the study hypotheses.
Primary outcome measures will include electrocortical indices under resting and mental task states and will evaluate the degree of neuro-physiological and cortical functional connectivity change following treatment as a proxy measure for neuroplastic response to the GZNT training. Secondary outcomes will include physiological stress response (as an objective measure of emotional regulation), neuropsychological test performance (as an objective measure of cognition), and self-reported symptom and emotional well-being measures. Feasibility outcomes will include number of visits completed within the six weeks, number and reason for drop-outs, adverse event profiles, and patient satisfaction questionnaires.
Methodology/Technical: For this pilot study, the investigators will require twenty-five patients to complete the study. The investigators will therefore recruit as many as are necessary to achieve this goal, to a maximum of 50 patients. However, since this is a feasibility study, the dropout rate and reasons for drop outs will be monitored and reported. Completion of a minimum of fifteen study treatment visits will satisfy requirements for "study completion." (This is based on clinical experience data with this technology.) Therefore, only those who complete fourteen or fewer sessions within the six week study treatment time window will be counted as drop outs. The planned total number of study sessions for the study will be twenty. Data analysis will be carried out on pre and post metrics for the group who completed the trial, and secondary analyses will be carried out on all subjects using an intention-to-treat paradigm, to evaluate feasibility, and acceptance of this intervention.
Subjects will be recruited from the Warrior Recovery Center, the Soldier Readiness Center, and Evans Army Hospital Primary Care Clinics. Subjects will be pre-screened by signing an initial consent and completing a preliminary set of self-report forms, followed by a review of medical records in order to determine eligibility. Following eligibility determination, full consent discussion will be held, and baseline evaluations will be completed and study visits scheduled.
For this pilot efficacy/feasibility study, all study subjects will receive the study treatment intervention. Dose exposure will begin at 10 minutes of GZNT at the first session and progress to a maximum of thirty minutes of training by the sixth or seventh visit, and continue at thirty minutes per visit for the remainder of the study.
- Conditions
- Traumatic Brain Injury
- Being tested
- Global Z-Score Neurofeedback Training
- Keywords
- mTBI, cognition disorders, post-concussive syndrome, neuroplasticity, EEG, biofeedback, stress disorder/post-traumatic, depression
- Medical subject headings
- Brain Injuries, Traumatic, Cognition Disorders, Post-Concussion Syndrome, Combat Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Z-Score Neurofeedback TrainingBehavioural
The experimental intervention in this study, Global Z-Score Neurofeedback Training, is a non-pharmacological EEG Biofeedback training process using a specific new technology that allows for the training to be semi-automated and to train based on referencing EEG activity in 19 sites on the scalp, whilst comparing in real time to a database of non-clinical normative EEG data. Subjects will be scheduled to receive 20 treatment sessions of GZNT over a six-week period, aiming for four treatment visits per week, but allowing for some missed appointments due to holidays and duty obligations.
Training will be conducted for a continuous time which will begin at 10 minutes in the first session, and progress to a maximum of 30 minutes by the sixth or seventh session, and then remain at 30 minutes of training per session for the remainder of the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | The experimental intervention in this study, Global Z-Score Neurofeedback Training, is a non-pharmacological EEG Biofeedback training process using a specific new technology that allows for the training to be semi-automated and to train based on referencing EEG activity in 19 sites on the scalp, whilst comparing in real time to a database of non-clinical normative EEG data. Subjects will be scheduled to receive 20 treatment sessions of GZNT over a six-week period, aiming for four treatment visits per week, but allowing for some missed appointments due to holidays and duty obligations.
Training will be conducted for a continuous time which will begin at 10 minutes in the first session, and progress to a maximum of 30 minutes by the sixth or seventh session, and then remain at 30 minutes of training per session for the remainder of the sessions. Receives: Behavioral: Global Z-Score Neurofeedback Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered Electrocortical Patterns
EEG measures - Global Z-Score metric for 5 variables in 4 frequency bands - measure std diff within subject and for group
Measured: 3 months post treatment
Secondary outcomes (2)
Effects on Attention
Event-Related Potentials, Event-Related DeSynchronization patterns, and Behavioral Response Data from Attention Network Task
Measured: 3 months post treatment
Effects on Memory
WAIS-IV Letter Number Sequencing, HVLT-R (auditory), BVMT-R (visual), WMS-IV Logical Memory test.
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionOct 2017
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Defense and Veterans Brain Injury Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Renee M Pazdan, MD, Principal investigator, The Defense and Veterans Brain Injury Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509689
- Sponsor's protocol ID
- W91YTZ-13-P-0703
- Acronym
- GZNT
- Status last verified
- Mar 2022
- First submitted
- 13 May 2015
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Hershaw JN, Hill-Pearson CA, Arango JI, Souvignier AR, Pazdan RM. Semi-Automated Neurofeedback Therapy for Persistent Postconcussive Symptoms in a Military Clinical Setting: A Feasibility Study. Mil Med. 2020 Mar 2;185(3-4):e457-e465. doi: 10.1093/milmed/usz335.
PubMed 31603218Hershaw J, Hill-Pearson CA, Arango JI, Souvignier AR, Pazdan RM. Changes in attentional processing following neurofeedback in patients with persistent post-concussive symptoms: a pilot study. Brain Inj. 2020 Dec 5;34(13-14):1723-1731. doi: 10.1080/02699052.2020.1812720. Epub 2020 Nov 16.
PubMed 33196305Hershaw JN, Hill-Pearson CA. Changes in EEG Activity Following Live Z-Score Training Predict Changes in Persistent Post-concussive Symptoms: An Exploratory Analysis. Front Neurol. 2022 Mar 21;13:714913. doi: 10.3389/fneur.2022.714913. eCollection 2022.
PubMed 35392637
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Novel Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers
- ClinicalTrials.gov ID
- NCT02509689
- Acronym / sponsor ID
- GZNT / W91YTZ-13-P-0703
- Conditions
- Traumatic Brain Injury
- Keywords
- mTBI, cognition disorders, post-concussive syndrome, neuroplasticity, EEG, biofeedback, stress disorder/post-traumatic, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- The Defense and Veterans Brain Injury CenterUS federal agency
- Study start
- Dec 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 28 Jul 2015 (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.
A new technology called Global Z-Score Neurofeedback Technology (GZNT) has been identified that can overcome an existing barrier to the use of neurofeedback as a treatment technique in a military setting. Neurofeedback, or EEG Biofeedback, is a form of biofeedback that uses the brain's own electrical activity as the training parameter. With sufficient practice, the brain can learn to change its own activity through finely tuned feedback using computerized sounds, graphs and animations. Previous attempts at using neurofeedback as a treatment modality have been subject to a lack of standardization and have required significant expertise on the part of the provider. This new GZNT technology allows neurofeedback to be administered in a standardized and semi-automated fashion, which, if effective, will represent a significant advance toward providing this promising treatment modality to Service Members in a military or VA setting. This study will determine feasibility and preliminary evidence of efficacy for this neurofeedback technology in a pilot study of soldiers with medical issues associated with Traumatic Brain Injury (TBI). GZNT technology has the potential to provide a cost-efficient, non-invasive/non-pharmacological approach to recovery from impact and/or blast-induced brain injury, and holds promise to simultaneously address emotional symptoms that are often a part of the post-concussion symptom picture.
Detailed description
Research Design: This will be a single group design, treatment effect and feasibility study to demonstrate GZNT technology, examining electrocortical changes, and comparing emotional/vocational functioning, and post concussive symptoms before and after intensive GZNT treatment, and at three months follow-up. Up to 50 subjects with a history of traumatic brain injury and persistent cognitive and emotional symptoms will be enrolled following screening and baseline evaluation. Resting and event-related EEG (electroencephalograph) recordings, a physiological stress evaluation, neuropsychological tests, self-report symptom scales, and psychosocial/vocational functioning measures will be performed at each evaluation. All subjects will receive the study treatment intervention. Subjects will be scheduled to receive twenty treatment sessions of GZNT over a six week period, but will be counted as having completed treatment if they attend fifteen or more sessions. At least twenty-five subjects will need to complete treatment to meet statistical requirements for the study hypotheses.
Primary outcome measures will include electrocortical indices under resting and mental task states and will evaluate the degree of neuro-physiological and cortical functional connectivity change following treatment as a proxy measure for neuroplastic response to the GZNT training. Secondary outcomes will include physiological stress response (as an objective measure of emotional regulation), neuropsychological test performance (as an objective measure of cognition), and self-reported symptom and emotional well-being measures. Feasibility outcomes will include number of visits completed within the six weeks, number and reason for drop-outs, adverse event profiles, and patient satisfaction questionnaires.
Methodology/Technical: For this pilot study, the investigators will require twenty-five patients to complete the study. The investigators will therefore recruit as many as are necessary to achieve this goal, to a maximum of 50 patients. However, since this is a feasibility study, the dropout rate and reasons for drop outs will be monitored and reported. Completion of a minimum of fifteen study treatment visits will satisfy requirements for "study completion." (This is based on clinical experience data with this technology.) Therefore, only those who complete fourteen or fewer sessions within the six week study treatment time window will be counted as drop outs. The planned total number of study sessions for the study will be twenty. Data analysis will be carried out on pre and post metrics for the group who completed the trial, and secondary analyses will be carried out on all subjects using an intention-to-treat paradigm, to evaluate feasibility, and acceptance of this intervention.
Subjects will be recruited from the Warrior Recovery Center, the Soldier Readiness Center, and Evans Army Hospital Primary Care Clinics. Subjects will be pre-screened by signing an initial consent and completing a preliminary set of self-report forms, followed by a review of medical records in order to determine eligibility. Following eligibility determination, full consent discussion will be held, and baseline evaluations will be completed and study visits scheduled.
For this pilot efficacy/feasibility study, all study subjects will receive the study treatment intervention. Dose exposure will begin at 10 minutes of GZNT at the first session and progress to a maximum of thirty minutes of training by the sixth or seventh visit, and continue at thirty minutes per visit for the remainder of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Behavioral: Global Z-Score Neurofeedback TrainingThe experimental intervention in this study, Global Z-Score Neurofeedback Training, is a non-pharmacological EEG Biofeedback training process using a specific new technology that allows for the training to be semi-automated and to train based on referencing EEG activity in 19 sites on the scalp, whilst comparing in real time to a database of non-clinical normative EEG data. Subjects will be scheduled to receive 20 treatment sessions of GZNT over a six-week period, aiming for four treatment visits per week, but allowing for some missed appointments due to holidays and duty obligations. Training will be conducted for a continuous time which will begin at 10 minutes in the first session, and progress to a maximum of 30 minutes by the sixth or seventh session, and then remain at 30 minutes of training per session for the remainder of the sessions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Mild to Moderate Traumatic brain injury patients at least three months and not more than 5 years post-injury with recovery to a Rancho los Amigos level of seven or eight (alert and oriented);
- Brain injury documented in the medical record by a history of an injury event and at least one of the following:
- Persistent symptoms thought to be related to or co morbid with the brain injury event, to include two or more complaints related to problems with attention, memory, concentration, speed of processing, judgment, executive control, depression, anxiety, agitation, irritability, impulsivity, or aggression, headaches, and sleep disturbance;
- Evidence of emotional problems as defined by scores on the Post-Traumatic Stress Disorder Checklist, Military version (PCL-M) of 33 or more, or 9 or more on the Patient Health Questionnaire (PHQ-9);
- Military or Veteran beneficiary;
Key exclusion criteria (7 listed)
- Current/prior (last six months) unstable medical or psychiatric condition that could confound the effect of the TBI event on brain function (e.g. clear anoxic episode, cardiac arrest, current uncontrolled diabetes, psychosis)
- A previous history of severe TBI prior to the current injury;
- Current (last three months) active suicidal or homicidal ideation or intent;
- Current (last month) drug/alcohol abuse or dependence as determined by clinical assessment in addition to the AUDIT-C screening tool. Patients with problem drinking as defined by a score of 6 or higher on the AUDIT-C will not be eligible to participate due to concerns regarding the neurotoxic effects of alcohol following TBI. Those with scores of 4 or 5 will be counseled to reduce their intake of alcohol during the time course of the study, and a clinical determination will be made by the PI or Sub-I as to whether they can be included in the study.
- Use of certain medications due to potential interference with assessments and treatment response: benzodiazepines - excluded; narcotic analgesics - allowed only if occasional use, and not within 24 hrs of any evaluation or treatment session; nootropic medications - excluded.
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 |
|---|---|---|
| Global Z-Score Neurofeedback TrainingThe experimental intervention in this study, Global Z-Score Neurofeedback Training, is a non-pharmacological EEG Biofeedback training process using a specific new technology that allows for the training to be semi-automated and to train based on referencing EEG activity in 19 sites on the scalp, whilst comparing in real time to a database of non-clinical normative EEG data. Subjects will be scheduled to receive 20 treatment sessions of GZNT over a six-week period, aiming for four treatment visits per week, but allowing for some missed appointments due to holidays and duty obligations. Training will be conducted for a continuous time which will begin at 10 minutes in the first session, and progress to a maximum of 30 minutes by the sixth or seventh session, and then remain at 30 minutes of training per session for the remainder of the sessions. | Behavioural | Single Arm |
Primary outcome
Altered Electrocortical Patterns
Time frame: 3 months post treatment
EEG measures - Global Z-Score metric for 5 variables in 4 frequency bands - measure std diff within subject and for group
2 secondary outcomes
Effects on Attention
Time frame: 3 months post treatment
Effects on Memory
Time frame: 3 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Results publication: PubMed 31603218Hershaw JN, Hill-Pearson CA, Arango JI, Souvignier AR, Pazdan RM. Semi-Automated Neurofeedback Therapy for Persistent Postconcussive Symptoms in a Military Clinical Setting: A Feasibility Study. Mil Med. 2020 Mar 2;185(3-4):e457-e465. doi: 10.1093/milmed/usz335.
- Results publication: PubMed 33196305Hershaw J, Hill-Pearson CA, Arango JI, Souvignier AR, Pazdan RM. Changes in attentional processing following neurofeedback in patients with persistent post-concussive symptoms: a pilot study. Brain Inj. 2020 Dec 5;34(13-14):1723-1731. doi: 10.1080/02699052.2020.1812720. Epub 2020 Nov 16.
- Results publication: PubMed 35392637Hershaw JN, Hill-Pearson CA. Changes in EEG Activity Following Live Z-Score Training Predict Changes in Persistent Post-concussive Symptoms: An Exploratory Analysis. Front Neurol. 2022 Mar 21;13:714913. doi: 10.3389/fneur.2022.714913. eCollection 2022.
- Changes in EEG Activity Following Live Z-Score Training Predict Changes in Persistent Post-concussive Symptoms: An Exploratory AnalysisLink provided by the sponsor.
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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.
Renee M Pazdan, MD principal investigator
The Defense and Veterans Brain Injury 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 Global Z-Score Neurofeedback Training in people with Traumatic Brain Injury, run by The Defense and Veterans Brain Injury Center 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 7 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: finished, as of the sponsor's last update on 4 Apr 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Altered Electrocortical Patterns (time frame: 3 months post treatment). 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 NCT02509689, which also lists 3 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 4 Apr 2022; AzTrials last refreshed its copy on 4 Nov 2026.