Chronic AphasiaCATChESNCT01928602
Computerised Therapy in Chronic Stroke
A study testing TherAppy Language App and Mind-Games in people with Chronic Aphasia, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The few studies looking systematically into the neurophysiological and neuropsychological components of available therapies for chronic aphasia are highly heterogeneous in nature. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Aphasia
- What is being tested?
- TherAppy Language App and Mind-Games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left hemisphere stroke
- Clinical presentation of first ever stroke
- Nonfluent/Expressive Aphasia: impairment in language production and spared language comprehension
- Age >18 years
- Adequate co-operation for scanning
- Right handed before stroke as tested with the Edinburgh inventory
Show all 13Show fewer
- Native British-English speakers (this is due to the nature of the fMRI task and inner speech battery, which rely upon words that are rhymes or homophones in the British English language)
- No history of neurological or psychiatric disorders
- No current specific cognitive deficit other than the language deficit
- No contra-indication to MRI scan as indicated by the WBIC protocol
- Patients able to lie flat in the scanner for 2 hours
- Consent obtained prior to initiating the study from the patient, in accordance with Local Research Ethics Committee guidelines
- Stroke and subsequent aphasia having been present for more than 12 months (ie, chronic)
Who cannot join
- For successful fMRI scans (relevant for all participants):
- Women with any chance of pregnancy
- Claustrophobia
- Any contra-indication to MRI as indicated by the WBIC protocol
- Concomitant medical disorder that means the patient is unable to lie flat comfortably in the scanner for a maximum of 2 hours (e.g. poorly controlled or severe respiratory disease or severe joint disease)
- All recruited patients:
Show all 14Show fewer
- History of significant pre-morbid cognitive impairment
- Alcohol or illicit drug abuse
- Severe deafness or visual impairment
- History of significant neurological disease (e.g. epilepsy, multiple sclerosis)
- Major organ failure that may complicate imaging studies (e.g. significant cardiac or liver disease)
- Of those patients recruited, further exclusion from crossover study:
- Demonstration of intact inner speech with good overt speech
- Demonstration of poor inner speech with poor overt speech
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Inner Speech Improve Access to Overt Speech in Aphasia Following Stroke? An fMRI Study Utilising Computerised Rehabilitation Software.
The few studies looking systematically into the neurophysiological and neuropsychological components of available therapies for chronic aphasia are highly heterogeneous in nature. Results from these studies have, unsurprisingly, indicated heterogeneous results, such as dissimilar neural outcomes associated with neuropsychological gains. There is, therefore, no consensus of how a successful therapy- that is, one that produces a measurable language gain in either production or comprehension -impacts the functional language networks of the brain in a specific type of aphasia population.
A recent study has shown that inner speech (the imagination of speech) involves networks and areas dissociable from those implicated in speech production. Further, behavioural analysis has shown an interesting discrepancy between inner speech and overt speech (also called speech production) in a small chronic aphasia population: some participants elicited poor inner speech coupled with relatively intact overt speech, while others elicited relatively intact inner speech coupled with poor overt speech. This unexplored discrepancy implies that inner speech and speech production are dissociable, though share similar networks.
Read more
This discrepancy, and the notion that these speech components share a similar network, drives this study's hypothesis that improvement in speech production after rehabilitation might be facilitated by an intact inner speech network. Much as good athletes visualise their performance before the actual event in order to increase their chances of success, so too might intact inner speech facilitate speech production, helping to visualise the word in order to increase the success of produced speech.
By studying a specific component of speech-inner speech-in a relatively homogeneous population of chronic expressive aphasics, the present study provides an explicit, critical means of understanding neurophysiological (as assessed by functional magnetic resonance imaging) and neuropsychological (as assessed by language batteries and personal questionnaires/interviews) changes occurring during speech therapy.
As a secondary objective, this study will explore the effectiveness, feasibility and adherence to an at-home computerised aphasia software delivered via a portable tablet.
Read the detailed description
15 million people worldwide have a stroke each year, with 152,000 in the United Kingdom. Recent estimates suggest that roughly 33% of patients suffering a stroke develop aphasia, a loss or impairment of language function caused by brain damage, which can have a significant impact on all aspects of an individual's life, as well as that of their carers. Aphasia can often be long-term, or chronic, affecting patients at least a year or more after their initial stroke.
Few studies have systematically investigated the effects of rehabilitation on brain mechanisms recruited to support recovery in stroke. Studies in this area are highly heterogeneous. The heterogeneity largely stems from 'lesion-related or language deficit-related differences in the patients studied'. Participants across and sometimes within the few studies conducted in this area vary with regard to the type of aphasia or time-following-stroke. These studies also boast differences including the type and dosage of treatment, the type of scanning task used to evaluate the desired effects of treatment, and the type of data analysis employed. Results from these studies have, unsurprisingly, indicated dissimilar neural outcomes associated with neuropsychological gains, such as increased right hemisphere (contra-lateral) involvement, or, in contrast, increased peri-lesional activation. There is, therefore, no consensus of how 'successful therapies' (that is, those that elicit some kind of language gain, either in comprehension or production) impact the language networks of the brain.
"It is well known that individuals with aphasia differ greatly with often varying language patterns and associated lesions, and even study participants carefully selected for their deficit patterns are seldom, if ever, homogeneous" . People with aphasia will, and do, differ markedly. Given this predicament, it becomes necessary to systematically control the other parts of the study, which includes limiting the imaging tasks and analysis to one component of the language system and using a powerful design, such as a crossover with two therapeutic conditions.
This study therefore aims to use systematic methodology to add information to the diminutive body of literature concerning chronic aphasia rehabilitation by exploring a specific component of the language network, inner speech, and its potential influence on speech production (neurophysiologically and neuropsychologically).
A previous study has shown that inner speech involves networks and areas dissociable from those implicated in speech production, such as the left inferior frontal gyrus, especially the pars opercularis and the supramarginal gyrus. Further, behavioural analysis has shown an interesting interaction of inner and overt speech in a small chronic aphasic population, whereas some chronic stroke patients showed poor inner speech coupled with good overt speech, while others showed good inner speech coupled with poor overt speech. This finding implies an unexplored relationship between the two networks: conceivably, that improvement in speech production during rehabilitation might be facilitated by an intact inner speech network.
There are hundreds of aphasia therapies on the market today. In general, two types of therapy exist: impairment-based and communication-based. Impairment-based therapies are those that specifically target increasing the ability of components of the language system, such as naming, reading, writing and sentence structure, and comprise most of the therapies on the market. Communication-based therapies are more informal, aiming to stimulate conversation by any means. The most utilised therapies for aphasia include constraint-induced therapy, which involves constraining the participant to using only words and not gestures in their communication, thus hoping to free the individual of non-speech compensatory strategies; melodic intonation therapy, based on the observation that people with aphasia have a better success rate if singing words rather than just saying words, uses melody as a crucial component for relearning speech; and various phonological cueing or naming therapies, which use repetition, semantic and phonological cueing based on specific anomia (naming) deficits. Aphasia therapies are so prevalent because, unlike drug therapies, they carry very little risk. This does not mean, however, that each aphasia therapy on the market is effective for all types of aphasia deficits. The scientific community lacks understanding of these therapies in several facets: understanding which treatments produce language gains in specific populations (i.e., chronic vs. acute individuals, fluent vs. non-fluent aphasia types); how language gains map onto changes in neurological function; and the trajectory of language gains over time, neuropsychologically and neurologically.
Utilising an at-home computerised aphasia rehabilitation program, this study will explore whether inner speech can assist patients in restoring access to spoken language, therefore resulting in improvement of language production (as assessed by neuropsychological examinations) and instigating changes in functional networks (as assessed by functional magnetic resonance imaging).
The computerised therapy was chosen because of its detailed clinical output system, its ability to be personalised to each individual, and its ability to adapt difficulty levels to the needs of the user. A successful at-home therapy program may provide a means to combat the lacking resources for continued rehabilitation outside of acute, hospital settings. As a secondary outcome, this study will investigate the success, feasibility and adherence to this software by collecting qualitative patient feedback and by analysing the software's quantitative outputs, such as exercise completion and number of times attempted, total time used and overall performance on the exercises.
- Conditions
- Chronic Aphasia
- Being tested
- TherAppy Language App, Mind-Games
- Keywords
- Crossover, Chronic stroke, Stroke, Rehabilitation, Language Therapy, Aphasia, Aphasia Therapy, Computerised Therapy, Computerised Rehabilitation, Tablet, Apps, Aphasia Rehabilitation, Rehabilitation on Portable Tablets
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherAppy Language AppBehavioural
Language TherAppy combines the receptive exercises of Comprehension TherAppy and Reading TherAppy with the expressive training of Naming TherAppy and Writing TherAppy. The app uses the same core functional vocabulary (nouns, verbs, \& adjectives) and over 700 clear pictures. Each app tracks data, sends professional e-mailed reports, and has built-in levels, cues, and options.
Mind-GamesBehavioural
A mind-game app is said to improve brain functioning at any age. The chosen app will give feedback such as score history, and progress reports. Tasks will focus on attention, memory spatial awareness and executive function.
| Study group | Role | What they receive |
|---|---|---|
| Expressive Aphasia Group A | Experimental | 1. Behavioral: TherAppy Language App
2. Behavioral: Mind-Games Receives: Behavioral: TherAppy Language App; Behavioral: Mind-Games |
| Expressive Aphasia Group B | Experimental | 1. Behavioral: Mind-Games
2. Behavioral: TherAppy Language App Receives: Behavioral: TherAppy Language App; Behavioral: Mind-Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients showing functional brain changes in inner speech circuits after computerised therapy
The primary outcome of this research is to investigate the brain changes related to computerised therapy in inner speech circuits in chronic aphasia. Changes in brain function will be measured by fMRI using an inner speech task.
Measured: Baseline and at post-therapy (dependent upon crossover design, might be at 5 week or 10 week after baseline)
Secondary outcomes (1)
Patient scores on effectiveness, feasibility and adherence to computerised therapy used on a portable tablet.
The secondary objective evaluates the effectiveness, feasibility and adherence to an example of computerised therapy. Analysis of this secondary objective will include qualitative feedback from participant responses on questionnaires and interviews, as well as quantitative feedback from the software's output and behavioural progress results.
Measured: Baseline and at completion of study (~18 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic AphasiaStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Gates Cambridge
- Responsible party
- Principal investigator, Brielle Stark, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Elizabeth Warburton, Dr., Study director, Cambridge University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928602
- Sponsor's protocol ID
- A092982
- Acronym
- CATChES
- Status last verified
- Jan 2018
- First submitted
- 19 Aug 2013
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stark BC, Warburton EA. Improved language in chronic aphasia after self-delivered iPad speech therapy. Neuropsychol Rehabil. 2018 Jul;28(5):818-831. doi: 10.1080/09602011.2016.1146150. Epub 2016 Feb 29.
PubMed 26926872
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Inner Speech Improve Access to Overt Speech in Aphasia Following Stroke? An fMRI Study Utilising Computerised Rehabilitation Software.
- ClinicalTrials.gov ID
- NCT01928602
- Acronym / sponsor ID
- CATChES / A092982
- Conditions
- Chronic Aphasia
- Keywords
- Crossover, Chronic stroke, Stroke, Rehabilitation, Language Therapy, Aphasia, Aphasia Therapy, Computerised Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Gates Cambridge
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Aug 2013 (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.
The few studies looking systematically into the neurophysiological and neuropsychological components of available therapies for chronic aphasia are highly heterogeneous in nature. Results from these studies have, unsurprisingly, indicated heterogeneous results, such as dissimilar neural outcomes associated with neuropsychological gains. There is, therefore, no consensus of how a successful therapy- that is, one that produces a measurable language gain in either production or comprehension -impacts the functional language networks of the brain in a specific type of aphasia population.
A recent study has shown that inner speech (the imagination of speech) involves networks and areas dissociable from those implicated in speech production. Further, behavioural analysis has shown an interesting discrepancy between inner speech and overt speech (also called speech production) in a small chronic aphasia population: some participants elicited poor inner speech coupled with relatively intact overt speech, while others elicited relatively intact inner speech coupled with poor overt speech. This unexplored discrepancy implies that inner speech and speech production are dissociable, though share similar networks.
This discrepancy, and the notion that these speech components share a similar network, drives this study's hypothesis that improvement in speech production after rehabilitation might be facilitated by an intact inner speech network. Much as good athletes visualise their performance before the actual event in order to increase their chances of success, so too might intact inner speech facilitate speech production, helping to visualise the word in order to increase the success of produced speech.
By studying a specific component of speech-inner speech-in a relatively homogeneous population of chronic expressive aphasics, the present study provides an explicit, critical means of understanding neurophysiological (as assessed by functional magnetic resonance imaging) and neuropsychological (as assessed by language batteries and personal questionnaires/interviews) changes occurring during speech therapy.
As a secondary objective, this study will explore the effectiveness, feasibility and adherence to an at-home computerised aphasia software delivered via a portable tablet.
Detailed description
15 million people worldwide have a stroke each year, with 152,000 in the United Kingdom. Recent estimates suggest that roughly 33% of patients suffering a stroke develop aphasia, a loss or impairment of language function caused by brain damage, which can have a significant impact on all aspects of an individual's life, as well as that of their carers. Aphasia can often be long-term, or chronic, affecting patients at least a year or more after their initial stroke.
Few studies have systematically investigated the effects of rehabilitation on brain mechanisms recruited to support recovery in stroke. Studies in this area are highly heterogeneous. The heterogeneity largely stems from 'lesion-related or language deficit-related differences in the patients studied'. Participants across and sometimes within the few studies conducted in this area vary with regard to the type of aphasia or time-following-stroke. These studies also boast differences including the type and dosage of treatment, the type of scanning task used to evaluate the desired effects of treatment, and the type of data analysis employed. Results from these studies have, unsurprisingly, indicated dissimilar neural outcomes associated with neuropsychological gains, such as increased right hemisphere (contra-lateral) involvement, or, in contrast, increased peri-lesional activation. There is, therefore, no consensus of how 'successful therapies' (that is, those that elicit some kind of language gain, either in comprehension or production) impact the language networks of the brain.
"It is well known that individuals with aphasia differ greatly with often varying language patterns and associated lesions, and even study participants carefully selected for their deficit patterns are seldom, if ever, homogeneous" . People with aphasia will, and do, differ markedly. Given this predicament, it becomes necessary to systematically control the other parts of the study, which includes limiting the imaging tasks and analysis to one component of the language system and using a powerful design, such as a crossover with two therapeutic conditions.
This study therefore aims to use systematic methodology to add information to the diminutive body of literature concerning chronic aphasia rehabilitation by exploring a specific component of the language network, inner speech, and its potential influence on speech production (neurophysiologically and neuropsychologically).
A previous study has shown that inner speech involves networks and areas dissociable from those implicated in speech production, such as the left inferior frontal gyrus, especially the pars opercularis and the supramarginal gyrus. Further, behavioural analysis has shown an interesting interaction of inner and overt speech in a small chronic aphasic population, whereas some chronic stroke patients showed poor inner speech coupled with good overt speech, while others showed good inner speech coupled with poor overt speech. This finding implies an unexplored relationship between the two networks: conceivably, that improvement in speech production during rehabilitation might be facilitated by an intact inner speech network.
There are hundreds of aphasia therapies on the market today. In general, two types of therapy exist: impairment-based and communication-based. Impairment-based therapies are those that specifically target increasing the ability of components of the language system, such as naming, reading, writing and sentence structure, and comprise most of the therapies on the market. Communication-based therapies are more informal, aiming to stimulate conversation by any means. The most utilised therapies for aphasia include constraint-induced therapy, which involves constraining the participant to using only words and not gestures in their communication, thus hoping to free the individual of non-speech compensatory strategies; melodic intonation therapy, based on the observation that people with aphasia have a better success rate if singing words rather than just saying words, uses melody as a crucial component for relearning speech; and various phonological cueing or naming therapies, which use repetition, semantic and phonological cueing based on specific anomia (naming) deficits. Aphasia therapies are so prevalent because, unlike drug therapies, they carry very little risk. This does not mean, however, that each aphasia therapy on the market is effective for all types of aphasia deficits. The scientific community lacks understanding of these therapies in several facets: understanding which treatments produce language gains in specific populations (i.e., chronic vs. acute individuals, fluent vs. non-fluent aphasia types); how language gains map onto changes in neurological function; and the trajectory of language gains over time, neuropsychologically and neurologically.
Utilising an at-home computerised aphasia rehabilitation program, this study will explore whether inner speech can assist patients in restoring access to spoken language, therefore resulting in improvement of language production (as assessed by neuropsychological examinations) and instigating changes in functional networks (as assessed by functional magnetic resonance imaging).
The computerised therapy was chosen because of its detailed clinical output system, its ability to be personalised to each individual, and its ability to adapt difficulty levels to the needs of the user. A successful at-home therapy program may provide a means to combat the lacking resources for continued rehabilitation outside of acute, hospital settings. As a secondary outcome, this study will investigate the success, feasibility and adherence to this software by collecting qualitative patient feedback and by analysing the software's quantitative outputs, such as exercise completion and number of times attempted, total time used and overall performance on the exercises.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expressive Aphasia Group A | Experimental | Behavioral: TherAppy Language App, Behavioral: Mind-Games1. Behavioral: TherAppy Language App 2. Behavioral: Mind-Games |
| Expressive Aphasia Group B | Experimental | Behavioral: TherAppy Language App, Behavioral: Mind-Games1. Behavioral: Mind-Games 2. Behavioral: TherAppy Language App |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Left hemisphere stroke
- Clinical presentation of first ever stroke
- Nonfluent/Expressive Aphasia: impairment in language production and spared language comprehension
- Age >18 years
- Adequate co-operation for scanning
Key exclusion criteria (14 listed)
- Women with any chance of pregnancy
- Claustrophobia
- Any contra-indication to MRI as indicated by the WBIC protocol
- Concomitant medical disorder that means the patient is unable to lie flat comfortably in the scanner for a maximum of 2 hours (e.g. poorly controlled or severe respiratory disease or severe joint disease)
- History of significant pre-morbid cognitive impairment
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 |
|---|---|---|
| TherAppy Language AppLanguage TherAppy combines the receptive exercises of Comprehension TherAppy and Reading TherAppy with the expressive training of Naming TherAppy and Writing TherAppy. The app uses the same core functional vocabulary (nouns, verbs, \& adjectives) and over 700 clear pictures. Each app tracks data, sends professional e-mailed reports, and has built-in levels, cues, and options. | Behavioural | Expressive Aphasia Group A, Expressive Aphasia Group B |
| Mind-GamesA mind-game app is said to improve brain functioning at any age. The chosen app will give feedback such as score history, and progress reports. Tasks will focus on attention, memory spatial awareness and executive function. | Behavioural | Expressive Aphasia Group A, Expressive Aphasia Group B |
Primary outcome
Number of patients showing functional brain changes in inner speech circuits after computerised therapy
Time frame: Baseline and at post-therapy (dependent upon crossover design, might be at 5 week or 10 week after baseline)
The primary outcome of this research is to investigate the brain changes related to computerised therapy in inner speech circuits in chronic aphasia. Changes in brain function will be measured by fMRI using an inner speech task.
1 secondary outcome
Patient scores on effectiveness, feasibility and adherence to computerised therapy used on a portable tablet.
Time frame: Baseline and at completion of study (~18 weeks later)
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 10 Jan 2018.
- Results publication: PubMed 26926872Stark BC, Warburton EA. Improved language in chronic aphasia after self-delivered iPad speech therapy. Neuropsychol Rehabil. 2018 Jul;28(5):818-831. doi: 10.1080/09602011.2016.1146150. Epub 2016 Feb 29.
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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.
Elizabeth Warburton, Dr. study director
Cambridge University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TherAppy Language App and Mind-Games in people with Chronic Aphasia, run by Cambridge University Hospitals NHS Foundation Trust 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 13 inclusion and 14 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 10 Jan 2018. 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?
Number of patients showing functional brain changes in inner speech circuits after computerised therapy (time frame: Baseline and at post-therapy (dependent upon crossover design, might be at 5 week or 10 week after baseline)). 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 NCT01928602, which also lists 1 linked publication.
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 10 Jan 2018.