StrokeNCT02482350
App-delivered Therapy for Arabic Readers With Hemianopic Alexia
A study testing Reading Training in people with Stroke, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
Hemianopia refers to compromised vision in one half of the visual field, in either one or both eyes. Hemianopic Alexia (HA) is a reading disorder related to such impairment, usually caused by stroke or head injury. Read more about this study
- Who is it for?
- Ages 26 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Reading Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Dec 2019
- 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 26 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must:
- Have a right-sided hemispheric stroke, tumor or head injury
- Demonstrate a fixed left visual field homonymous deficit as defined by missing one or more stimuli on the automated visual field test developed for the application
- Have a baseline text reading speed of more than 40 words per minute
- Have been Arabic readers premorbidly
Who cannot join
- Patients presenting:
- impaired speech production, speech comprehension or writing (to rule out those with central alexia)
- a premorbid history of neurological or psychiatric illness
- a baseline text reading speed of less than 40 words per minute (to exclude patients with pure alexia) will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Hemianopia refers to compromised vision in one half of the visual field, in either one or both eyes. Hemianopic Alexia (HA) is a reading disorder related to such impairment, usually caused by stroke or head injury. In order to read, participants have to move their eyes along a line of text three to four times per second. Such eye movements are called saccades. One makes use of peripheral visual information to the right (if reading from left to right, e.g., in English) or to the left (if reading from right to left, e.g., in Arabic) of words. HA patients are deprived of much of this information. Patients with HA require far more saccades, which slows their reading significantly and often prevents them from reading efficiently for work or pleasure. It follows that the reading ability of those who read left-to-right would be compromised more by right-sided HA, and in those who read right-to-left by a left-sided HA. This study proposes to explore the rehabilitation of left-sided HA following stroke, in Arabic readers. An online treatment package has been developed in English (http://www.readright.ucl.ac.uk/). Currently, no assessment or treatment resources exist for the condition in right-to-left readers. The aim is to develop novel Arabic reading tests and rehabilitation material. The current project proposes to 1) translate this package into Arabic, 2) develop new Arabic reading test materials and 3) collect data from Arabic reading stroke patients in a Phase 2 clinical trial. The hope is to develop an effective, novel, and empirically supported reading treatment package for Arabic readers with HA.
Read the detailed description
Background
Purpose and Experimental Design Reading a line of text is usually achieved by planning a series of saccades, which allow the eyes to jump from one word to another (reading scan-path). Arabic readers use peripheral visual information to the left of the word in order to plan their reading eye movements. Patients with HA are deprived of this information and compensate by creating inefficient reading scan-paths with many additional saccades, resulting in accurate but slow reading. Some patients abandon reading altogether, or lose their jobs because they cannot read fast enough.
Healthy subjects read moving (scrolling) text faster than static text. This type of text, also called "Times Square" presentation, induces a form of involuntary eye movement called optokinetic nystagmus (OKN) in the reader and, when used as part of a rehabilitation program, has been shown to improve subsequent reading performance of static text.
This study proposes to adapt these techniques for scrolling Arabic text, and to test them in Arabic-reading patients with left-sided HA. Rehabilitation material will be made available on the Internet (via an iPhone and/or iPad Application ('app')) for suitable subjects, in order to investigate whether patients benefit from using them outside of controlled trial conditions. During pre- and post-therapeutic intervention the investigators will record the following: reading speeds, visual field test scores, visual search test scores, eye-movements, and Activities of Daily Living scores. Length of time for which patients access rehabilitation material, will also be recorded.
This study will help determine the efficacy of Internet-based behavioural rehabilitation. It will also provide information as to: 1) how much improvement may be gained through this program, and 2) how much practice patients will likely require in order to improve their reading significantly.
Objectives
This study proposes:
- Adapt and test reading rehabilitation techniques in patients with left-sided HA, using scrolling Arabic text;
- Investigate whether patients benefit from using such material outside of controlled trial conditions.
Hypothesis
- Patients will report a significant improvement in the speed at which they read static text (newspaper, books, letters, etc.) as a function of quality activity of daily living.
- Patients will decrease the number of fixations (both progressive and regressive type saccades) when reading static text.
Methods Thirteen Arabic-reading patients with left-sided homonymous HA following stroke will be studied over a period of three months. A single-subject baseline control design will be employed. There will be a treatment-free interval before and after reading therapy. Baseline assessments of visual fields, eye movement performance during text reading, text reading speed, and visual search performance will be carried out pre-intervention. Behavioural assessments will be repeated immediately following every five hours of therapy, and during follow-up. Patients will determine how long to wait between testing points, as they will differ in reading speeds.
Patients meeting the study criteria will be identified through Dr. Alex Leff's Alexia clinic at the National Hospital for Neurology and Neurosurgery, University College London Hospital (UCLH), as well as through formal collaboration with the neuropsychology department at Wellington Hospital. In addition, patients will be given the option to join the study when downloading the reading therapy app from the Apple iTunes store. An online consent form will be included in the registration. The aim is to recruit at least thirteen patients to this study over the following three years.
Thirteen healthy age-matched Arabic reading controls will be recruited from a variety of sources, including relatives and friends of patients. Controls will undergo the same assessment as patients, but will be assessed only once. They will not undergo the reading therapy.
Consent Initially, both the information sheet and consent forms will be delivered in hard copy (written in both Arabic and English). When the application has been developed, pilot study will be conducted. Participants will complete online consent forms, and will be required to click certain key boxes to confirm that they have read or listened to, and understood, the information.
Risks, Burdens, and Benefits:
Benefits. App-delivered reading therapy has never before been available as a rehabilitation package for Arabic reading patients with HA. The app may be used as stand-alone self-help reading therapy, or as part of formal speech-language therapy. Additional benefits include real-time activity monitoring, tracking of treatment progress, personalised feedback and motivation support, portability and flexibility of use, and the potential to improve with practice.
Risks/Burdens. This will be the first study in patients with left-sided HA using scrolling Arabic text. Thus there is little literature to guide the study. In order to maximize its potential, the investigators will adapt the established English-reading treatment approach used for patients with right-sided HA. There is no way of predicting how many patients will use the application. Some participants may not meet the study criteria. In addition, the patients themselves will manage their use of the application. There is therefore an inherent risk of their not accessing the rehabilitation materials for the required period of time, and not entering the data correctly.
Data Collection
Participants will be required to enter the following data in order to gain full access to the rehabilitation material:
Data to be collected on App-based patients
- A unique login, created by themselves. (This does not have to be their real name.) This will ensure that each time they access the application; their data is collected under their name.
- Their email address (optional), for use only if they forget their login details.
- The extent and side of their hemianopia. If they have not had this test performed by their own doctor or optometrist, a section of this application provides self-testing.
- A test of their reading speed. This will be self-administered. Participants will time themselves (a timer on the application will be activated by the touch screen) reading a standard text aloud. Their text reading speed will be calculated and feedback to them. Participants may check or recheck this at various times during the study.
- A test of their performance on a visual search test. This will be self-administered. Participants will be tested on their accuracy and speed when finding objects on a section of the application. Their performance scores will be calculated and feedback to them. Participants may check or recheck this at various times during the study.
- Participants will rate themselves on their ability to perform activities of daily living (ADLs) as a measure of their functional status in regards to their reading impairment. Their scores will be calculated but not feedback to them.
Other optional fields, which may prove useful in data analysis if enough subjects complete them will include:
- The cause of their hemianopia. (This is usually stroke or head injury, but a free text option will be provided.)
- How much reading they can manage with their hemianopia
- Whether their hemianopia has caused them to change or loose their employment
Participants will access the app and enter all personal data themselves. The only data we will collect that is not directly controlled by the participants is the amount of time they access the rehabilitation materials and their logon identification. The latter will ensure that the same participant is not logging on to the application under multiple names.
Rehabilitation materials used in the app-based reading training The rehabilitation materials will consist simply of chapters of text, which scroll from left-to-right: that is, from the blind visual field of the participants to their normal visual field. The texts will be sourced from books out of copyright, freely available on the Internet. The aim is to provide streaming text from other websites, such as news, current affairs etc. The participant may control the speed at which the text scrolls. Participants will be advised to practice the reading therapy on most days and to aim for 20 to 40 minutes per day. They will also be asked to test their reading speeds every time they complete five hours of rehabilitation. Subjects will be prompted to check their reading speeds after every five hours of exposure to therapy. If they choose not to record any of this data, their access to the rehabilitation materials will not be affected.
Data to be collected on Face-to-Face patients Patients with HA adopt an inefficient reading strategy to compensate for their visual impairment on the hemianopic side. Therefore, we want to compare the patients' reading scan-paths to those generated by healthy controls reading the same static passages. We will be recording eye movements of participants as they read 10 passages using an eye-tracking device. A between groups statistical analysis will be performed.
- Conditions
- Stroke
- Being tested
- Reading Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading TrainingBehavioural
Healthy subjects read moving (scrolling) text faster than static text. This type of text, also called "Times Square" presentation, induces a form of involuntary eye movement called optokinetic nystagmus (OKN) in the reader and, when used as part of a rehabilitation program, has been shown to improve subsequent reading performance of static text.
| Study group | Role | What they receive |
|---|---|---|
| Reading Training | Experimental | A 3-months study design. There will be three distinct phases: base-line testing, reading training, and follow-up testing. T1-T7 indicate the 7 time-points at which we assess the following: reading speeds (word-per-minute), visual field test, visual search test, and Activities of Daily Living rating scale (T1: Day 1, Initial assessments; T2: Day 30, Pre-training assessments; T3: Day 60, During Reading Training (RT) after 5-hours; T4: During RT after 10-hours; T5: During RT after 15-hours; T6: During RT after 20-hour; T7: Day 90, Post-training assessments). Arabic reading patients with left-sided HA will receive app-delivered reading training in a single subject control based design for 1 month. Receives: Behavioral: Reading Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of reading speed
Average total reading time will be calculated in words per minute (wpm) using descriptive statistics in IBM SPSS.
Measured: 1 month
Secondary outcomes (3)
Patients will report improvement in static text reading (newspapers, books, letters, etc.) as a function of quality activity of daily living.
Participants will rate themselves on their ability to perform activities of daily living (ADLs) as a measure of their functional status in regards to their reading impairment.
Measured: 2 months
Decrease in the number of fixations
Fixation: maintaining visual gaze on a single location
Measured: 1 month
Decrease in average fixation durations
Fixation duration: length of fixational pauses during reading
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Crinion, University College London Hospitals
- Investigators
- Jennifer T Crinion, PhD, Principal investigator, Institute of Cognitive Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482350
- Sponsor's protocol ID
- 150817
- Status last verified
- May 2023
- First submitted
- 15 Jun 2015
- Last updated
- 11 May 2023
- 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-delivered Therapy for Arabic Readers With Hemianopic Alexia
- ClinicalTrials.gov ID
- NCT02482350
- Acronym / sponsor ID
- 150817
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 26 Jun 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.
Hemianopia refers to compromised vision in one half of the visual field, in either one or both eyes. Hemianopic Alexia (HA) is a reading disorder related to such impairment, usually caused by stroke or head injury. In order to read, participants have to move their eyes along a line of text three to four times per second. Such eye movements are called saccades. One makes use of peripheral visual information to the right (if reading from left to right, e.g., in English) or to the left (if reading from right to left, e.g., in Arabic) of words. HA patients are deprived of much of this information. Patients with HA require far more saccades, which slows their reading significantly and often prevents them from reading efficiently for work or pleasure. It follows that the reading ability of those who read left-to-right would be compromised more by right-sided HA, and in those who read right-to-left by a left-sided HA. This study proposes to explore the rehabilitation of left-sided HA following stroke, in Arabic readers. An online treatment package has been developed in English (http://www.readright.ucl.ac.uk/). Currently, no assessment or treatment resources exist for the condition in right-to-left readers. The aim is to develop novel Arabic reading tests and rehabilitation material. The current project proposes to 1) translate this package into Arabic, 2) develop new Arabic reading test materials and 3) collect data from Arabic reading stroke patients in a Phase 2 clinical trial. The hope is to develop an effective, novel, and empirically supported reading treatment package for Arabic readers with HA.
Detailed description
Background
Purpose and Experimental Design Reading a line of text is usually achieved by planning a series of saccades, which allow the eyes to jump from one word to another (reading scan-path). Arabic readers use peripheral visual information to the left of the word in order to plan their reading eye movements. Patients with HA are deprived of this information and compensate by creating inefficient reading scan-paths with many additional saccades, resulting in accurate but slow reading. Some patients abandon reading altogether, or lose their jobs because they cannot read fast enough.
Healthy subjects read moving (scrolling) text faster than static text. This type of text, also called "Times Square" presentation, induces a form of involuntary eye movement called optokinetic nystagmus (OKN) in the reader and, when used as part of a rehabilitation program, has been shown to improve subsequent reading performance of static text.
This study proposes to adapt these techniques for scrolling Arabic text, and to test them in Arabic-reading patients with left-sided HA. Rehabilitation material will be made available on the Internet (via an iPhone and/or iPad Application ('app')) for suitable subjects, in order to investigate whether patients benefit from using them outside of controlled trial conditions. During pre- and post-therapeutic intervention the investigators will record the following: reading speeds, visual field test scores, visual search test scores, eye-movements, and Activities of Daily Living scores. Length of time for which patients access rehabilitation material, will also be recorded.
This study will help determine the efficacy of Internet-based behavioural rehabilitation. It will also provide information as to: 1) how much improvement may be gained through this program, and 2) how much practice patients will likely require in order to improve their reading significantly.
Objectives
This study proposes:
- Adapt and test reading rehabilitation techniques in patients with left-sided HA, using scrolling Arabic text;
- Investigate whether patients benefit from using such material outside of controlled trial conditions.
Hypothesis
- Patients will report a significant improvement in the speed at which they read static text (newspaper, books, letters, etc.) as a function of quality activity of daily living.
- Patients will decrease the number of fixations (both progressive and regressive type saccades) when reading static text.
Methods Thirteen Arabic-reading patients with left-sided homonymous HA following stroke will be studied over a period of three months. A single-subject baseline control design will be employed. There will be a treatment-free interval before and after reading therapy. Baseline assessments of visual fields, eye movement performance during text reading, text reading speed, and visual search performance will be carried out pre-intervention. Behavioural assessments will be repeated immediately following every five hours of therapy, and during follow-up. Patients will determine how long to wait between testing points, as they will differ in reading speeds.
Patients meeting the study criteria will be identified through Dr. Alex Leff's Alexia clinic at the National Hospital for Neurology and Neurosurgery, University College London Hospital (UCLH), as well as through formal collaboration with the neuropsychology department at Wellington Hospital. In addition, patients will be given the option to join the study when downloading the reading therapy app from the Apple iTunes store. An online consent form will be included in the registration. The aim is to recruit at least thirteen patients to this study over the following three years.
Thirteen healthy age-matched Arabic reading controls will be recruited from a variety of sources, including relatives and friends of patients. Controls will undergo the same assessment as patients, but will be assessed only once. They will not undergo the reading therapy.
Consent Initially, both the information sheet and consent forms will be delivered in hard copy (written in both Arabic and English). When the application has been developed, pilot study will be conducted. Participants will complete online consent forms, and will be required to click certain key boxes to confirm that they have read or listened to, and understood, the information.
Risks, Burdens, and Benefits:
Benefits. App-delivered reading therapy has never before been available as a rehabilitation package for Arabic reading patients with HA. The app may be used as stand-alone self-help reading therapy, or as part of formal speech-language therapy. Additional benefits include real-time activity monitoring, tracking of treatment progress, personalised feedback and motivation support, portability and flexibility of use, and the potential to improve with practice.
Risks/Burdens. This will be the first study in patients with left-sided HA using scrolling Arabic text. Thus there is little literature to guide the study. In order to maximize its potential, the investigators will adapt the established English-reading treatment approach used for patients with right-sided HA. There is no way of predicting how many patients will use the application. Some participants may not meet the study criteria. In addition, the patients themselves will manage their use of the application. There is therefore an inherent risk of their not accessing the rehabilitation materials for the required period of time, and not entering the data correctly.
Data Collection
Participants will be required to enter the following data in order to gain full access to the rehabilitation material:
Data to be collected on App-based patients
- A unique login, created by themselves. (This does not have to be their real name.) This will ensure that each time they access the application; their data is collected under their name.
- Their email address (optional), for use only if they forget their login details.
- The extent and side of their hemianopia. If they have not had this test performed by their own doctor or optometrist, a section of this application provides self-testing.
- A test of their reading speed. This will be self-administered. Participants will time themselves (a timer on the application will be activated by the touch screen) reading a standard text aloud. Their text reading speed will be calculated and feedback to them. Participants may check or recheck this at various times during the study.
- A test of their performance on a visual search test. This will be self-administered. Participants will be tested on their accuracy and speed when finding objects on a section of the application. Their performance scores will be calculated and feedback to them. Participants may check or recheck this at various times during the study.
- Participants will rate themselves on their ability to perform activities of daily living (ADLs) as a measure of their functional status in regards to their reading impairment. Their scores will be calculated but not feedback to them.
Other optional fields, which may prove useful in data analysis if enough subjects complete them will include:
- The cause of their hemianopia. (This is usually stroke or head injury, but a free text option will be provided.)
- How much reading they can manage with their hemianopia
- Whether their hemianopia has caused them to change or loose their employment
Participants will access the app and enter all personal data themselves. The only data we will collect that is not directly controlled by the participants is the amount of time they access the rehabilitation materials and their logon identification. The latter will ensure that the same participant is not logging on to the application under multiple names.
Rehabilitation materials used in the app-based reading training The rehabilitation materials will consist simply of chapters of text, which scroll from left-to-right: that is, from the blind visual field of the participants to their normal visual field. The texts will be sourced from books out of copyright, freely available on the Internet. The aim is to provide streaming text from other websites, such as news, current affairs etc. The participant may control the speed at which the text scrolls. Participants will be advised to practice the reading therapy on most days and to aim for 20 to 40 minutes per day. They will also be asked to test their reading speeds every time they complete five hours of rehabilitation. Subjects will be prompted to check their reading speeds after every five hours of exposure to therapy. If they choose not to record any of this data, their access to the rehabilitation materials will not be affected.
Data to be collected on Face-to-Face patients Patients with HA adopt an inefficient reading strategy to compensate for their visual impairment on the hemianopic side. Therefore, we want to compare the patients' reading scan-paths to those generated by healthy controls reading the same static passages. We will be recording eye movements of participants as they read 10 passages using an eye-tracking device. A between groups statistical analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reading Training | Experimental | Behavioral: Reading TrainingA 3-months study design. There will be three distinct phases: base-line testing, reading training, and follow-up testing. T1-T7 indicate the 7 time-points at which we assess the following: reading speeds (word-per-minute), visual field test, visual search test, and Activities of Daily Living rating scale (T1: Day 1, Initial assessments; T2: Day 30, Pre-training assessments; T3: Day 60, During Reading Training (RT) after 5-hours; T4: During RT after 10-hours; T5: During RT after 15-hours; T6: During RT after 20-hour; T7: Day 90, Post-training assessments). Arabic reading patients with left-sided HA will receive app-delivered reading training in a single subject control based design for 1 month. |
Who may qualify
- Ages
- 26 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must:
Key exclusion criteria (4 listed)
- Patients presenting:
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 |
|---|---|---|
| Reading TrainingHealthy subjects read moving (scrolling) text faster than static text. This type of text, also called "Times Square" presentation, induces a form of involuntary eye movement called optokinetic nystagmus (OKN) in the reader and, when used as part of a rehabilitation program, has been shown to improve subsequent reading performance of static text. | Behavioural | Reading Training |
Primary outcome
Improvement of reading speed
Time frame: 1 month
Average total reading time will be calculated in words per minute (wpm) using descriptive statistics in IBM SPSS.
3 secondary outcomes
Patients will report improvement in static text reading (newspapers, books, letters, etc.) as a function of quality activity of daily living.
Time frame: 2 months
Decrease in the number of fixations
Time frame: 1 month
Decrease in average fixation durations
Time frame: 1 month
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 11 May 2023.
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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.
Jennifer T Crinion, PhD principal investigator
Institute of Cognitive Neuroscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading Training in people with Stroke, run by University College London Hospitals at 1 site in United Kingdom.
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 5 inclusion and 4 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 11 May 2023. 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 Kingdom. 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?
Improvement of reading speed (time frame: 1 month). 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 11 May 2023.