StrokeNCT02062619
Brain Mechanisms Underlying Reading Improvement in Central Alexia
A study testing Computer-based behavioural word reading therapy and Real tDCS in people with Stroke and Brain Injuries, run by University College, London at 1 site in United Kingdom.
Trial summary
Central alexia is a common reading disorder caused by stroke. Patients with central alexia (CA) are slow to read and make frequent errors, and have additional problems with their spoken language. This study has 3 aims: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Brain Injuries, Aphasia
- What is being tested?
- Computer-based behavioural word reading therapy and Real tDCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Left hemisphere stroke or other focal brain injury
- English as a first language
- At least one year post stroke
- Impaired reading ability (defined according to screening with the Comprehensive Aphasia Test, CAT)
- Mild to moderate aphasia (defined according to screening with the CAT)
- Competent to give informed consent
Who cannot join
- Hemorrhagic stroke
- History of significant premorbid neurological or psychiatric illness
- History of developmental reading or speech and language disability
- Severe speech production deficit (defined according to screening with the CAT)
- Damage to tDCS target region (left inferior frontal gyrus)
- Contraindications to MRI scanning (e.g. presence of ferromagnetic implants or other metallic or electronic objects in the body; weight over 24 stone; claustrophobia or pregnancy).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Neurology, University College London
London, WC1N 3AR
About this study
Central alexia is a common reading disorder caused by stroke. Patients with central alexia (CA) are slow to read and make frequent errors, and have additional problems with their spoken language.
This study has 3 aims:
Read more
- Investigating the neural networks that support reading in patients with CA Despite being a relatively common syndrome, there have been no functional brain imaging studies of CA. This project will use magnetic resonance imaging (MRI) and magnetoencephalography (MEG) to understand which brain regions are damaged and whether preserved parts of the reading network can be encouraged by therapy to support reading recovery.
- Testing a new treatment for CA The research team has developed training software called 'iReadMore', which uses a crossmodal approach (written words paired with spoken words) to train reading. This therapy has been shown to be effective in patients with a similar form of reading disorder called pure alexia. The iReadMore software will be adapted to address the reading deficit in CA, and the research will test whether it significantly improves reading ability.
- Using brain stimulation to enhance behavioural training Transcranial direct current stimulation (tDCS) is a brain stimulation technique that has been shown to improve language performance in healthy controls and stroke patients. This study will test whether tDCS (delivered simultaneously with the 'iReadMore' therapy) significantly enhances reading rehabilitation. Patients will be split into two groups: one will receive a 4 week block of training plus real tDCS first, followed by a 4 week block of training plus sham tDCS; the other group will receive the two therapy blocks in the opposite order. Both groups will ultimately receive the same amount of behavioural therapy and tDCS stimulation. Comparing the reading improvement over the real and sham tDCS blocks will demonstrate whether tDCS enhances the behavioural improvements in reading ability.
Hypothesis:
iReadMore reading therapy will significantly improve single word reading speed in patients with central alexia.
tDCS brain stimulation will significantly enhance the effect of iReadMore therapy, compared to sham stimulation.
Read the detailed description
Central alexia is a common acquired reading disorder usually caused by stroke (Leff \& Behrmann, 2008). Patients also have generalized language impairments (aphasia), distinguishing it from other acquired reading disorders such as pure alexia, where the reading deficit occurs in isolation. Aphasia is the second most common severe impairment caused by stroke (limb weakness is the first) and reading problems (central alexia) are often associated with it. An analysis of our local database (from which we will be recruiting patients) shows that of the 212 patients with aphasia 14 (66.5%) have central alexia. The severity of central alexia varies across patients but even mild central alexia has a strong detrimental impact on quality of life, preventing patients from returning to work, communicating via email, text or post, or simply reading for pleasure.
Currently, there is no standard treatment for central alexia. Despite its prevalence, few patients receive sufficient reading therapy through the NHS. Only a few computer-based therapies have been tested at the group level (Katz \& Wertz, 1997; Cherney, 2010) and only one, a beta version of Oral Reading for Language in Aphasia (by Cherney), is currently available commercially for patients to use. We aim to test the efficacy of 'iReadMore', software designed to improve word reading speed for use in this patient group.
iReadMore is a cross-modal reading training method that was developed as a word reading therapy for patients with pure alexia in a previous study (Woodhead et al, 2013). iReadMore consists of audio-visual pairings of words. It was designed to strengthen orthographic processing of written words by boot-strapping them to auditory percepts and associated higher-order representations (lexical/semantic). Use of the 'iReadMore' software led to a significant improvement in word reading speed for trained words and significantly decreased the word length effect that is characteristic of pure alexia (Woodhead et al, 2013).
The mechanisms underlying the behavioural improvements following iReadMore training were investigated using magnetoencephalography (MEG), an imaging modality optimized to test connectivity-based hypotheses in the hundred millisecond temporal range. Dynamic Causal Modelling (DCM) analyses were used to test training-related changes in connectivity within the reading network comprising. Training strengthened connectivity in the left hemisphere, most notably feedback from left inferior frontal gyrus (IFG) to the visual cortex, a connection which we have shown to be involved early on (within 200ms) when healthy controls read (Woodhead et al, 2012). This led to the hypothesis that feedback from the left IFG drives reading recovery, and that tDCS stimulation of this region, with its connections to both ventral and dorsal temporal cortex, will enhance behavioural training improvements in patients with central alexia.
Although this previous research has focused on pure alexia, a recent pilot study has provided promising evidence that iReadMore may also be beneficial for patients with central alexia. The results demonstrated that iReadMore training and tDCS produced a large, statistically significant improvement of around 600ms per word, a 28% reduction from baseline levels. This effect was observed for both trained and untrained items. Training continued for a further two weeks with sham tDCS with no further significant improvement. A planned fourth tDCS time-point was lost due to patient illness. Although not statistically significant, we observed a trend with performance on untrained items appearing to deteriorate over time. This is in accord with evidence that tDCS may well have a role in consolidation of practice rather than a simple effect on performance alone (Reis et al, 2009).
Summary:
Pilot data has demonstrated that cross-modal iReadMore training is effective in patients with pure alexia; and that its effects are supported by feedback from the left IFG. This work led to the prediction that iReadMore may also be effective in treating the more prevalent and understudied condition of central alexia, and that targeted stimulation of the left IFG with tDCS may enhance the training efficacy. This prediction has already been supported by a preliminary case study, and the present study will expand this further into a group study looking at the effects and mechanisms of rehabilitation of central alexia.
- Conditions
- Stroke, Brain Injuries, Aphasia
- Being tested
- Computer-based behavioural word reading therapy, Real tDCS, Sham tDCS
- Keywords
- Stroke, Aphasia, Acquired reading disorders, Central alexia, Computer based rehabilitation, Transcranial direct current stimulation, tDCS, Magnetoencephalography, MEG, Magnetic Resonance Imaging, MRI
- Medical subject headings
- Stroke, Brain Injuries, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based behavioural word reading therapyBehavioural
Each patient participates in two blocks of reading training (one with real tDCS, one with sham tDCS). Different words will be trained in each training block.
Each training block comprises 10 hours of reading therapy per week for four weeks (three 1-hour sessions/week at research site; 1-hour of training/day at home)
Real tDCSOther
Real tDCS 20 minutes per session, three times per week
Sham tDCSOther
Sham tDCS, 20 minutes per session, 3 sessions per week
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Experimental | Transcranial direct current stimulation (tDCS) administered concurrently with computer-based behavioural word reading therapy.
2mA anodal direct current stimulation applied to the left inferior frontal gyrus (IFG) for first 20 minutes of therapy. Receives: Behavioral: Computer-based behavioural word reading therapy; Other: Real tDCS |
| Sham tDCS | Sham comparator | Transcranial direct current stimulation (tDCS) administered concurrently with computer-based behavioural word reading therapy.
Sham tDCS (periodical fade-in and fade-out stimulation routine) applied to the left inferior frontal gyrus (IFG) for first 20 minutes of therapy. Receives: Behavioral: Computer-based behavioural word reading therapy; Other: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in word reading speed and accuracy for trained and untrained words
Word reading speed and accuracy will be assessed at multiple time-points:
T1, T2: baseline assessments.
T3: following 1 month no training.
T4: following 1 month of iReadMore training with real / sham tDCS (crossover design).
T5: following 1 month of iReadMore training with sham / real tDCS (crossover allocation reversed).
T6: follow-up assessment after 3 months with no training.
Planned comparisons:
T3 vs [average of T1 and T2]: spontaneous improvement in reading ability
T4 vs T3 / T5 vs T4: comparison of improvement following iReadMore with real/sham tDCS
T6 vs T5: maintenance of therapy benefits at follow-up assessment.
Measured: Baseline and up to 3 months follow-up
Secondary outcomes (2)
Change in spoken word repetition for trained / untrained words
Accuracy of spoken word repetition for trained and untrained words will be assessed at T1-T6 and analysed using the same comparisons as word reading (primary outcome measure)
Measured: Baseline and up to 3 months follow-up
Change in semantic word matching for trained / untrained words
Reading for meaning (rather than reading aloud) will be assessed using a written word semantic matching task.
Speed and accuracy of semantic matching for trained and untrained words will be assessed at T1-T6 and analysed using the same comparisons as word reading (primary outcome measure)
Measured: Baseline and up to 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Leff, MBBS, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062619
- Sponsor's protocol ID
- MR/K022563/1
- Status last verified
- Apr 2016
- First submitted
- 12 Feb 2014
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kerry SJ, Aguilar OM, Penny W, Crinion JT, Leff AP, Woodhead ZVJ. How Does iReadMore Therapy Change the Reading Network of Patients with Central Alexia? J Neurosci. 2019 Jul 17;39(29):5719-5727. doi: 10.1523/JNEUROSCI.1426-18.2019. Epub 2019 May 13.
PubMed 31085605Woodhead ZVJ, Kerry SJ, Aguilar OM, Ong YH, Hogan JS, Pappa K, Leff AP, Crinion JT. Randomized trial of iReadMore word reading training and brain stimulation in central alexia. Brain. 2018 Jul 1;141(7):2127-2141. doi: 10.1093/brain/awy138.
PubMed 29912350
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms Underlying Reading Improvement in Central Alexia
- ClinicalTrials.gov ID
- NCT02062619
- Acronym / sponsor ID
- MR/K022563/1
- Conditions
- Stroke, Brain Injuries, Aphasia
- Keywords
- Stroke, Aphasia, Acquired reading disorders, Central alexia, Computer based rehabilitation, Transcranial direct current stimulation, tDCS, Magnetoencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 13 Feb 2014 (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.
Central alexia is a common reading disorder caused by stroke. Patients with central alexia (CA) are slow to read and make frequent errors, and have additional problems with their spoken language.
This study has 3 aims:
- Investigating the neural networks that support reading in patients with CA Despite being a relatively common syndrome, there have been no functional brain imaging studies of CA. This project will use magnetic resonance imaging (MRI) and magnetoencephalography (MEG) to understand which brain regions are damaged and whether preserved parts of the reading network can be encouraged by therapy to support reading recovery.
- Testing a new treatment for CA The research team has developed training software called 'iReadMore', which uses a crossmodal approach (written words paired with spoken words) to train reading. This therapy has been shown to be effective in patients with a similar form of reading disorder called pure alexia. The iReadMore software will be adapted to address the reading deficit in CA, and the research will test whether it significantly improves reading ability.
- Using brain stimulation to enhance behavioural training Transcranial direct current stimulation (tDCS) is a brain stimulation technique that has been shown to improve language performance in healthy controls and stroke patients. This study will test whether tDCS (delivered simultaneously with the 'iReadMore' therapy) significantly enhances reading rehabilitation. Patients will be split into two groups: one will receive a 4 week block of training plus real tDCS first, followed by a 4 week block of training plus sham tDCS; the other group will receive the two therapy blocks in the opposite order. Both groups will ultimately receive the same amount of behavioural therapy and tDCS stimulation. Comparing the reading improvement over the real and sham tDCS blocks will demonstrate whether tDCS enhances the behavioural improvements in reading ability.
Hypothesis:
iReadMore reading therapy will significantly improve single word reading speed in patients with central alexia.
tDCS brain stimulation will significantly enhance the effect of iReadMore therapy, compared to sham stimulation.
Detailed description
Central alexia is a common acquired reading disorder usually caused by stroke (Leff \& Behrmann, 2008). Patients also have generalized language impairments (aphasia), distinguishing it from other acquired reading disorders such as pure alexia, where the reading deficit occurs in isolation. Aphasia is the second most common severe impairment caused by stroke (limb weakness is the first) and reading problems (central alexia) are often associated with it. An analysis of our local database (from which we will be recruiting patients) shows that of the 212 patients with aphasia 14 (66.5%) have central alexia. The severity of central alexia varies across patients but even mild central alexia has a strong detrimental impact on quality of life, preventing patients from returning to work, communicating via email, text or post, or simply reading for pleasure.
Currently, there is no standard treatment for central alexia. Despite its prevalence, few patients receive sufficient reading therapy through the NHS. Only a few computer-based therapies have been tested at the group level (Katz \& Wertz, 1997; Cherney, 2010) and only one, a beta version of Oral Reading for Language in Aphasia (by Cherney), is currently available commercially for patients to use. We aim to test the efficacy of 'iReadMore', software designed to improve word reading speed for use in this patient group.
iReadMore is a cross-modal reading training method that was developed as a word reading therapy for patients with pure alexia in a previous study (Woodhead et al, 2013). iReadMore consists of audio-visual pairings of words. It was designed to strengthen orthographic processing of written words by boot-strapping them to auditory percepts and associated higher-order representations (lexical/semantic). Use of the 'iReadMore' software led to a significant improvement in word reading speed for trained words and significantly decreased the word length effect that is characteristic of pure alexia (Woodhead et al, 2013).
The mechanisms underlying the behavioural improvements following iReadMore training were investigated using magnetoencephalography (MEG), an imaging modality optimized to test connectivity-based hypotheses in the hundred millisecond temporal range. Dynamic Causal Modelling (DCM) analyses were used to test training-related changes in connectivity within the reading network comprising. Training strengthened connectivity in the left hemisphere, most notably feedback from left inferior frontal gyrus (IFG) to the visual cortex, a connection which we have shown to be involved early on (within 200ms) when healthy controls read (Woodhead et al, 2012). This led to the hypothesis that feedback from the left IFG drives reading recovery, and that tDCS stimulation of this region, with its connections to both ventral and dorsal temporal cortex, will enhance behavioural training improvements in patients with central alexia.
Although this previous research has focused on pure alexia, a recent pilot study has provided promising evidence that iReadMore may also be beneficial for patients with central alexia. The results demonstrated that iReadMore training and tDCS produced a large, statistically significant improvement of around 600ms per word, a 28% reduction from baseline levels. This effect was observed for both trained and untrained items. Training continued for a further two weeks with sham tDCS with no further significant improvement. A planned fourth tDCS time-point was lost due to patient illness. Although not statistically significant, we observed a trend with performance on untrained items appearing to deteriorate over time. This is in accord with evidence that tDCS may well have a role in consolidation of practice rather than a simple effect on performance alone (Reis et al, 2009).
Summary:
Pilot data has demonstrated that cross-modal iReadMore training is effective in patients with pure alexia; and that its effects are supported by feedback from the left IFG. This work led to the prediction that iReadMore may also be effective in treating the more prevalent and understudied condition of central alexia, and that targeted stimulation of the left IFG with tDCS may enhance the training efficacy. This prediction has already been supported by a preliminary case study, and the present study will expand this further into a group study looking at the effects and mechanisms of rehabilitation of central alexia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Behavioral: Computer-based behavioural word reading therapy, Other: Real tDCSTranscranial direct current stimulation (tDCS) administered concurrently with computer-based behavioural word reading therapy. 2mA anodal direct current stimulation applied to the left inferior frontal gyrus (IFG) for first 20 minutes of therapy. |
| Sham tDCS | Sham comparator | Behavioral: Computer-based behavioural word reading therapy, Other: Sham tDCSTranscranial direct current stimulation (tDCS) administered concurrently with computer-based behavioural word reading therapy. Sham tDCS (periodical fade-in and fade-out stimulation routine) applied to the left inferior frontal gyrus (IFG) for first 20 minutes of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years old
- Left hemisphere stroke or other focal brain injury
- English as a first language
- At least one year post stroke
- Impaired reading ability (defined according to screening with the Comprehensive Aphasia Test, CAT)
Key exclusion criteria (6 listed)
- Hemorrhagic stroke
- History of significant premorbid neurological or psychiatric illness
- History of developmental reading or speech and language disability
- Severe speech production deficit (defined according to screening with the CAT)
- Damage to tDCS target region (left inferior frontal gyrus)
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 |
|---|---|---|
| Computer-based behavioural word reading therapyEach patient participates in two blocks of reading training (one with real tDCS, one with sham tDCS). Different words will be trained in each training block. Each training block comprises 10 hours of reading therapy per week for four weeks (three 1-hour sessions/week at research site; 1-hour of training/day at home) | Behavioural | Real tDCS, Sham tDCS |
| Real tDCSReal tDCS 20 minutes per session, three times per week | Other | Real tDCS |
| Sham tDCSSham tDCS, 20 minutes per session, 3 sessions per week | Other | Sham tDCS |
Primary outcome
Change in word reading speed and accuracy for trained and untrained words
Time frame: Baseline and up to 3 months follow-up
Word reading speed and accuracy will be assessed at multiple time-points: T1, T2: baseline assessments. T3: following 1 month no training. T4: following 1 month of iReadMore training with real / sham tDCS (crossover design). T5: following 1 month of iReadMore training with sham / real tDCS (crossover allocation reversed). T6: follow-up assessment after 3 months with no training. Planned comparisons: T3 vs [average of T1 and T2]: spontaneous improvement in reading ability T4 vs T3 / T5 vs T4: comparison of improvement following iReadMore with real/sham tDCS T6 vs T5: maintenance of therapy benefits at follow-up assessment.
2 secondary outcomes
Change in spoken word repetition for trained / untrained words
Time frame: Baseline and up to 3 months follow-up
Change in semantic word matching for trained / untrained words
Time frame: Baseline and up to 3 months follow-up
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 Nov 2016.
- Derived from this study: PubMed 31085605Kerry SJ, Aguilar OM, Penny W, Crinion JT, Leff AP, Woodhead ZVJ. How Does iReadMore Therapy Change the Reading Network of Patients with Central Alexia? J Neurosci. 2019 Jul 17;39(29):5719-5727. doi: 10.1523/JNEUROSCI.1426-18.2019. Epub 2019 May 13.
- Derived from this study: PubMed 29912350Woodhead ZVJ, Kerry SJ, Aguilar OM, Ong YH, Hogan JS, Pappa K, Leff AP, Crinion JT. Randomized trial of iReadMore word reading training and brain stimulation in central alexia. Brain. 2018 Jul 1;141(7):2127-2141. doi: 10.1093/brain/awy138.
Related trials for Stroke
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
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.
Alex Leff, MBBS, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based behavioural word reading therapy and Real tDCS in people with Stroke and Brain Injuries, run by University College, London 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 7 inclusion and 6 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 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
Change in word reading speed and accuracy for trained and untrained words (time frame: Baseline and up to 3 months follow-up). 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 NCT02062619, which also lists 2 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 Nov 2016; AzTrials last refreshed its copy on 31 Oct 2026.