Traumatic Brain InjuryICARENCT05636020
Intervention to Change Affect Recognition and Empathy
A study testing ICARE Treatment in people with Traumatic Brain Injury and Concussion, Intermediate, run by Indiana University at 1 site in United States.
Trial summary
Determine the feasibility, practicality, and early efficacy of a TeleRehab program (ICARE) to improve outcomes for persons with traumatic brain injury (TBI) in recognizing and responding to others' emotions alongside their care partner (CP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Concussion, Intermediate, Concussion, Severe
- What is being tested?
- ICARE Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild, moderate, or severe TBI determined by The Ohio State University Traumatic Brain Injury Identification Method (OSU TBI-ID) during Time 1; if mild, must have been at least dazed and confused. Must be ≥ 1-year post-TBI (unlikely spontaneous recovery). Must have a care-partner (CP) willing to participate. Must either have a ≤ 45 T score on any one of the SASNOS Interpersonal Behavior subscales or Total Interpersonal behavior score, OR select never, rarely, or occasionally to #2, #6, #7, and/ or #12 (obtained during screening process). Also, either: A) Must be believed by person with TBI OR B) Person with TBI has been told by others OR CP, that their problems with recognizing and/ or empathizing with others' emotions (self or CP rated) are believed to be new or worse since TBI and impacting their interpersonal behaviors or relationships.
- Must be a relative, spouse, or friend who believes the have sufficient interactions (~3 times/ week) with the participant with TBI to judge their empathic, interpersonal, and other behaviors. Must be willing to participate in assessments and empathy sessions.
- Must be ≥18 years old. Must be a U.S. resident (exclusion for California residents). Must be proficient in English; have basic comprehension \& ability to follow directions (determined via interaction at screening); have access to a computer or tablet with reliable internet (capacity for video conferencing) with video-conferencing capability.
Who cannot join
- Any other formal neurological disorder or condition that impacts emotional functioning other than TBI (e.g., stroke); suicide risk determined to be >low risk based on PI discretion and/or results of suicide protocol (if triggered); unstable or anticipated medication changes that will influence mood/ affect during study participation; and individuals who recently started psychotherapy (e.g., < 3 months ago) and/or active treatment in family or couples therapy.
- Moderate to severe TBI determined by the "OSU TBI-ID + ABI" (i.e., scoring a 4 or 5 on Worst Injury Scale); If the person indicates a mild TBI (OSU score of 2 or 3) or any other neurological impairment on the OSU (e.g. a stroke), then the person will be asked follow-up questions to determine if there were any persistent changes in thinking, memory, mood, social functioning that they believe was a result of the injury. PI and/ or Co-PI discretion will be used to evaluate the answer and determine inclusion or exclusion.
- Developmental; neurodegenerative; major psychiatric disorder (e.g., schizophrenia, personality disorder); visual, hearing, or communication deficits that would impede participation; participation in IRB#12561; contemplating separation or divorce with the dyad partner
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46254
About this study
Official title: Intervention to Change Affect Recognition and Empathy (ICARE)
Determine the feasibility, practicality, and early efficacy of a TeleRehab program (ICARE) to improve outcomes for persons with traumatic brain injury (TBI) in recognizing and responding to others' emotions alongside their care partner (CP).
Read the detailed description
This phase I proof of principle pilot study of ICARE will be a non-randomized, one-group pre/posttest design with a double pretest, and an immediate posttest, with 3 and 6-month follow-ups in 40 participants with TBI and their CP. The study objectives are to explore the feasibility, practicality and early efficacy of ICARE to improve affect recognition (AR), empathy, interpersonal behaviors, and participation for persons with TBI. For CPs, goals are for them to feel more emotionally supported by the person with TBI; feel more in control of their own emotions, and have less CP anxiety. An additional objective for both participants with TBI and the CP is to enhance the quality and closeness of their relationship. For both TBI and CP participants, we anticipate ICARE will have good feasibility and acceptability, and post-treatment assessments will show significant improvements in perceived relationship closeness and relationship quality. For the TBI participants, we anticipate the post-treatment assessments will show significant improvements in affect recognition, empathy, interpersonal behavior, participation, and global impression of change. For the CPs, we anticipate the post-treatment assessments will show significant improvements in perceived emotional support (received from participant with TBI); suppression of self-emotions; and self-rated anxiety.
- Conditions
- Traumatic Brain Injury, Concussion, Intermediate, Concussion, Severe, Concussion With LOC 31 to 59 Minutes, Concussion With Brief Loss of Consciousness, Traumatic Brain Injury With Brief Loss of Consciousness
- Being tested
- ICARE Treatment
- Keywords
- brain injury, affect recognition, empathy, caregiver, interpersonal behaviors, relationship closeness, mood, teletherapy, social cognition, theory of mind, perspective taking
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICARE TreatmentBehavioural
The treatment is 12 teletherapy sessions lasting approximately 60-90 minutes. Of the 12 treatment sessions, 7 of them will focus on training skills to help the participant with TBI better recognize emotions from facial expressions. The remaining 5 sessions will teach skills important for empathizing with others' thoughts and feelings, and how to be emotionally supportive. Role-playing will be a big part of these last 5 sessions. The care-partner will be expected to attend as many of these 5 empathy sessions with the participant with TBI as possible.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ICARE) | Experimental | ICARE treatment consisting of 12 sessions that train affect recognition and empathic behaviors. Receives: Behavioral: ICARE Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in St. Andrew's Swansea Neurobehavioral Outcome Scale-Interpersonal Behavior (SASNOS-IB)
Behaviors and symptoms of neurobehavioral dysfunction are rated on items covering 5 major domains, one of which is interpersonal behavior, which has 3 subdomains (social interactions, relationships, engagement). Prevalence of behaviors are rated using a 7-point scale ('never' to 'always'). Participants with TBI and CP will only complete the Interpersonal Behavior (IB) domain about the person with TBI. Psychometric property testing indicated excellent discriminant validity and good test-retest reliability.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Secondary outcomes (13)
Change in The Diagnostic Assessment of Nonverbal Accuracy-2, Adult Faces (DANVA2-AF)
(TBI participant only) The DANVA2-AF is a standardized performance-based measure of facial affect recognition. Participants will be shown 24 photographs of 4 facial expressions (different faces from ICARE training) and required to select a response option from a list of choices. Scores range from 0-24. The DANVA2-AF has high internal consistency, test-retest reliability, and good convergent validity.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Advanced Clinical Solutions- Social Perception- Facial Affect Naming subscale (ACS-SP-FAN)
(TBI participant only) In this affect recognition test, participants are shown 24 faces (different from ICARE training) that express happy, sad, angry, fearful, disgust, surprise or neutral emotions and must choose from a list of response options. The ACS-SP-FAN has good discriminant validity, high internal consistency, and high test-retest reliability.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Brock Adaptive Functioning Questionnaire, empathy subscale (BAFQ-E)
This subjective measure, which has been designed for self and proxy ratings, includes several subscales (including empathy) to evaluate neurobehavioral functioning. Only the empathy subscale will be completed. Both the participant with TBI (self-rated) and their CP (about person with TBI). They will rate the frequency of occurrence of empathic behaviors on a 5-point scale. The BAFQ has high internal consistency, good concurrent validity with executive functioning measures, and correlates highly with caregiver stress and satisfaction, and return to work.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Daily Empathic Behavior Survey (DEBS)
(CP participant only) The DEBS was created for this study. For 1-week (7 days) intervals following each time frame point, CPs will be sent an electronic prompt to their cell phones at the end of the day and asked to rate the following statements on a scale from 1 (not at all) to 5 (extremely): Today, he/she 1) tried to understand others' thoughts, feelings, or problems; 2) considered others' perspectives and situations; 3) shared in others' feelings (e.g., felt sad with someone sad; felt happy with someone happy); 4) showed care and concern for others (e.g., asked, listened, comforted, consoled); 5) listened when others needed to talk; and 6) showed appreciation to others. If the CP did not interact with the participant that day, they will reply "no interaction" to that daily survey. While administered 7 times per time frame point/assessment period, the goal is a minimum of 3 completed surveys that period.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Participation Assessment with Combined Tools-Objective (PART-O)
(TBI participant only) PART-O is a standardized 17-item measure developed by the TBIMS to evaluate participation in the community with respect to three domains: Productivity, Social Relations, and Out and About. Items are scored on a 0 to 5 scale. Total PART-O scores will be used for our analyses.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Global Impression of Change
Using a 7-point Likert scale, participants with TBI and CP will be asked to rate the degree of change (1=no change; 7=a great deal better) in a) overall functioning, b) empathy, and c) social behaviors of the person with TBI, as believed to be related to ICARE.
Measured: Week 14, week 26, week 38
Change in Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Scale- modified
(CP participant only) This 8-item subjective measure requires participants to rate the degree of emotional support they receive using a 5-point Likert scale. It will be completed by CP and modified to specifically inquire about the emotional support they receive from the participant with TBI (as opposed to support from anyone). PROMIS item banks and their short forms have been found to be reliable and precise measures that are comparable to legacy instruments.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in TBI CareQol Emotional Suppression- Short Form
(CP participant only) Six items assess CP attempts to hide or suppress negative feelings in their caregiver role. Psychometric properties are strong.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in TBI CareQol Caregiver specific Anxiety
(CP participant only) This scale examines caregiver concerns about the person they care for with regard to behavior in public, mental health, mood, and fear for the future on a 5-point Likert-type scale ranging from 1 (Never) to 5 (Always). Scores are converted to a T-scale with a mean of 50 (SD=10). Higher scores indicate more anxiety. With rigorous development standards, it has been found to have strong psychometric properties.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Unidimensional Relationship Closeness Scale
To be completed by participants with TBI and their CP, this 12-item self-report scale measures the closeness of social and personal relationships using a 7-point Likert scale from Strongly Disagree to Strongly Agree. Has good psychometric qualities.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Relationship Quality Survey
This brief survey uses a 10-point scale to rate the quality of their relationship (from very poor to outstanding). It will be completed both by the participant with the TBI and their CP.
Measured: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Treatment Satisfaction
Participants with TBI and CP will complete a post-treatment survey regarding their satisfaction with content and with remote delivery of the therapy program, using a 9-point scale. For example, participants will be asked questions, such as: "Overall, how satisfied were you with ICARE therapy?" (Content satisfaction); and "How satisfied were you with receiving this type of treatment remotely/ via teletherapy?" (Teletherapy satisfaction). To guide future iterations, participants will be asked to describe 2-3 three things they liked, disliked and would change; and seek feedback on how the program could be improved.
Measured: Week 14
Perth Empathy Scale (PES)
The Perth Empathy Scale (PES) is a subjective measure that evaluates general empathy ability that can be separated into cognitive and affective (negative and positive) empathy domains on a 5-point scale (1=Almost never; 5=Almost always). This subjective measure has also been designed to capture informant ratings, thus, both the participant with TBI (self-rated) and their CP (about person with TBI) will be assessed. Higher scores represent better empathic ability. Total scores range from 20-100; subscale scores range from 10-50 each. Participants will rate the frequency of occurrence in each behavior or experience. The PES has high convergent validity, discriminant validity in comparison to constructs like alexithymia, and criterion validity in assessing empathy in both positive and negative emotions.
Measured: Week 7, week 14, week 26, week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start15 Mar 2023
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flora Hammond, Indiana University
- Investigators
- Flora Hammond, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636020
- Sponsor's protocol ID
- 16937
- Acronym
- ICARE
- Status last verified
- Aug 2026
- First submitted
- 22 Nov 2022
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Change Affect Recognition and Empathy (ICARE)
- ClinicalTrials.gov ID
- NCT05636020
- Acronym / sponsor ID
- ICARE / 16937
- Conditions
- Traumatic Brain Injury, Concussion, Intermediate, Concussion, Severe, Concussion With LOC 31 to 59 Minutes, Concussion With Brief Loss of Consciousness, Traumatic Brain Injury With Brief Loss of Consciousness
- Keywords
- brain injury, affect recognition, empathy, caregiver, interpersonal behaviors, relationship closeness, mood, teletherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 Dec 2022 (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.
Determine the feasibility, practicality, and early efficacy of a TeleRehab program (ICARE) to improve outcomes for persons with traumatic brain injury (TBI) in recognizing and responding to others' emotions alongside their care partner (CP).
Detailed description
This phase I proof of principle pilot study of ICARE will be a non-randomized, one-group pre/posttest design with a double pretest, and an immediate posttest, with 3 and 6-month follow-ups in 40 participants with TBI and their CP. The study objectives are to explore the feasibility, practicality and early efficacy of ICARE to improve affect recognition (AR), empathy, interpersonal behaviors, and participation for persons with TBI. For CPs, goals are for them to feel more emotionally supported by the person with TBI; feel more in control of their own emotions, and have less CP anxiety. An additional objective for both participants with TBI and the CP is to enhance the quality and closeness of their relationship. For both TBI and CP participants, we anticipate ICARE will have good feasibility and acceptability, and post-treatment assessments will show significant improvements in perceived relationship closeness and relationship quality. For the TBI participants, we anticipate the post-treatment assessments will show significant improvements in affect recognition, empathy, interpersonal behavior, participation, and global impression of change. For the CPs, we anticipate the post-treatment assessments will show significant improvements in perceived emotional support (received from participant with TBI); suppression of self-emotions; and self-rated anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ICARE) | Experimental | Behavioral: ICARE TreatmentICARE treatment consisting of 12 sessions that train affect recognition and empathic behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild, moderate, or severe TBI determined by The Ohio State University Traumatic Brain Injury Identification Method (OSU TBI-ID) during Time 1; if mild, must have been at least dazed and confused. Must be ≥ 1-year post-TBI (unlikely spontaneous recovery). Must have a care-partner (CP) willing to participate. Must either have a ≤ 45 T score on any one of the SASNOS Interpersonal Behavior subscales or Total Interpersonal behavior score, OR select never, rarely, or occasionally to #2, #6, #7, and/ or #12 (obtained during screening process). Also, either: A) Must be believed by person with TBI OR B) Person with TBI has been told by others OR CP, that their problems with recognizing and/ or empathizing with others' emotions (self or CP rated) are believed to be new or worse since TBI and impacting their interpersonal behaviors or relationships.
- Must be a relative, spouse, or friend who believes the have sufficient interactions (~3 times/ week) with the participant with TBI to judge their empathic, interpersonal, and other behaviors. Must be willing to participate in assessments and empathy sessions.
- Must be ≥18 years old. Must be a U.S. resident (exclusion for California residents). Must be proficient in English; have basic comprehension \& ability to follow directions (determined via interaction at screening); have access to a computer or tablet with reliable internet (capacity for video conferencing) with video-conferencing capability.
Key exclusion criteria (3 listed)
- Any other formal neurological disorder or condition that impacts emotional functioning other than TBI (e.g., stroke); suicide risk determined to be >low risk based on PI discretion and/or results of suicide protocol (if triggered); unstable or anticipated medication changes that will influence mood/ affect during study participation; and individuals who recently started psychotherapy (e.g., < 3 months ago) and/or active treatment in family or couples therapy.
- Moderate to severe TBI determined by the "OSU TBI-ID + ABI" (i.e., scoring a 4 or 5 on Worst Injury Scale); If the person indicates a mild TBI (OSU score of 2 or 3) or any other neurological impairment on the OSU (e.g. a stroke), then the person will be asked follow-up questions to determine if there were any persistent changes in thinking, memory, mood, social functioning that they believe was a result of the injury. PI and/ or Co-PI discretion will be used to evaluate the answer and determine inclusion or exclusion.
- Developmental; neurodegenerative; major psychiatric disorder (e.g., schizophrenia, personality disorder); visual, hearing, or communication deficits that would impede participation; participation in IRB#12561; contemplating separation or divorce with the dyad partner
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 |
|---|---|---|
| ICARE TreatmentThe treatment is 12 teletherapy sessions lasting approximately 60-90 minutes. Of the 12 treatment sessions, 7 of them will focus on training skills to help the participant with TBI better recognize emotions from facial expressions. The remaining 5 sessions will teach skills important for empathizing with others' thoughts and feelings, and how to be emotionally supportive. Role-playing will be a big part of these last 5 sessions. The care-partner will be expected to attend as many of these 5 empathy sessions with the participant with TBI as possible. | Behavioural | Treatment (ICARE) |
Primary outcome
Change in St. Andrew's Swansea Neurobehavioral Outcome Scale-Interpersonal Behavior (SASNOS-IB)
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Behaviors and symptoms of neurobehavioral dysfunction are rated on items covering 5 major domains, one of which is interpersonal behavior, which has 3 subdomains (social interactions, relationships, engagement). Prevalence of behaviors are rated using a 7-point scale ('never' to 'always'). Participants with TBI and CP will only complete the Interpersonal Behavior (IB) domain about the person with TBI. Psychometric property testing indicated excellent discriminant validity and good test-retest reliability.
13 secondary outcomes
Change in The Diagnostic Assessment of Nonverbal Accuracy-2, Adult Faces (DANVA2-AF)
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Advanced Clinical Solutions- Social Perception- Facial Affect Naming subscale (ACS-SP-FAN)
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Brock Adaptive Functioning Questionnaire, empathy subscale (BAFQ-E)
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Daily Empathic Behavior Survey (DEBS)
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Participation Assessment with Combined Tools-Objective (PART-O)
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Global Impression of Change
Time frame: Week 14, week 26, week 38
Change in Patient Reported Outcome Measurement Information System (PROMIS) Emotional Support Scale- modified
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in TBI CareQol Emotional Suppression- Short Form
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in TBI CareQol Caregiver specific Anxiety
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Unidimensional Relationship Closeness Scale
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Change in Relationship Quality Survey
Time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38
Treatment Satisfaction
Time frame: Week 14
Perth Empathy Scale (PES)
Time frame: Week 7, week 14, week 26, week 38
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 6 Aug 2026.
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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.
Flora Hammond, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICARE Treatment in people with Traumatic Brain Injury and Concussion, Intermediate, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. 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?
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?
Change in St. Andrew's Swansea Neurobehavioral Outcome Scale-Interpersonal Behavior (SASNOS-IB) (time frame: Baseline (pre-test 1), week 7, week 14, week 26, week 38). 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 6 Aug 2026.