DysphagiaFEAStNCT01919112
Fostering Eating After Stroke With Transcranial Direct Current Stimulation
A study testing tDCS in people with Dysphagia and Stroke, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Swallowing difficulties are common after a stroke and can lead to serious complications like pneumonia and malnutrition. Unfortunately, there are no effective treatment for improving swallowing in stroke patients. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 21 years or older in age since safety of non-invasive cortical stimulation in children.
- Between 25 hours (day 2) to 144 (day 6) hours since stroke onset.
- Unilateral hemispheric infarction (cortical or subcortical infarction) documented by imaging.
- Moderate to severe dysphagia with a score of 4 or more on Penetration and Aspiration Scale (PAS)
Who cannot join
- Prior history of swallowing difficulties.
- Drowsiness or marked cognitive impairment that interferes with participation in swallowing maneuvers.
- Unable to undergo an MRI due to claustrophobia or presence of electrically, magnetically or mechanically activated implant (including cardiac pacemaker), intracerebral vascular clips or any other electrically sensitive support system, metal in any part of the body, including metallic injury to eye, or pregnancy).
- History of seizures or unexplained episodes of loss of consciousness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Non-invasive Brain Stimulation for Swallowing Recovery After a Dysphagic Stroke
Swallowing difficulties are common after a stroke and can lead to serious complications like pneumonia and malnutrition. Unfortunately, there are no effective treatment for improving swallowing in stroke patients.
Previous investigations have shown that recovery of swallowing functions occurs from reorganization ("rewiring") of the non-involved cerebral hemisphere. In this study, the investigators propose to investigate a new intervention, which combines, swallowing exercises with brain stimulation targeted to the non-involved cerebral hemisphere, using low intensity current in acute stroke patients. The investigators plan to assess the safety of this technique in this patient population and also assess its effect on improving swallowing functions and swallowing physiology. During this time trial participants will undergo standardized swallowing and neurological assessments as well as brain MRI scans.
Read the detailed description
Swallowing impairments are a common and a serious complication of stroke but lack effective therapies. The study investigators herein propose to conduct a prospective clinical study using a non-invasive brain stimulation technique, anodal transcranial direct current stimulation (tDCS), in combination with swallowing exercises for improving dysphagia due to an acute-subacute hemispheric infarction, and obtain data on safety and effect of 2 different doses of tDCS, on swallowing physiology and behavior. Dysphagia from hemispheric strokes occurs due to disruption of the cortical projections to the brainstem swallowing centers while recovery of swallowing functions have been shown to be mediated via the reorganization of the swallowing cortex in the unaffected hemisphere. A recent pilot study conducted by the investigators demonstrated the safety and feasibility of applying 5 consecutive daily sessions of anodal tDCS for 30 minutes to the swallowing cortex on the unaffected hemisphere in the acute-subacute stroke phases and showed a promise in improving dysphagia, when combined with swallowing exercises. The proposed research will be used to further confirm safety of this technique in early stroke phases and explore alternative, more effective doses for promoting swallowing recovery prior to its examination in any confirmatory trials. The investigators will use the study cohort to examine important subject specific parameters which influence response to the proposed intervention in dysphagic stroke patients. The overall aim of this study is to gather additional safety data on cumulative sessions of tDCS in acute-subacute phases of stroke, obtain information about effects of this intervention on important physiological and clinically relevant swallowing parameters, examine possible dose effects, and identify candidates who are more likely to benefit from this intervention. The experience gained from this project will guide planning of future confirmatory trials that use relevant clinical outcomes to assess potential benefits of this intervention and utilize important subject specific parameters to refine study inclusion criteria and aid in severity adjusted analysis.
- Being tested
- tDCS
- Keywords
- Brain stimulation
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Anodal tDCS will be administered with swallowing exercises
| Study group | Role | What they receive |
|---|---|---|
| High dose anodal tDCS | Experimental | High dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises Receives: Device: tDCS |
| Low dose anodal tDCS | Active comparator | This arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises Receives: Device: tDCS |
| Sham Stimulation | Sham comparator | Twice daily swallowing exercises only Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess Changes in Penetration and Aspiration
This will be assessed using the Penetration and Aspiration Scale (PAS) scores, a validated 8 point ordinal scale that quantifies penetration and aspiration events observed during Videofluoroscopic Swallowing Evaluation. PAS ranges from 1 (best score) representing no aspiration or penetration to 8 (worst score) representing severe aspiration. An average PAS score will be computed based on 9 swallows for this outcome.
Measured: Scores will be measured before tDCS and after 5 days after completion of stimulation
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Seizures in Each of the 3 Groups
We will tabulate the number of participants who develop seizures in the High-dose anodal tDCS, Low-dose anodal tDCS and Sham stimulation groups.
Measured: During the 5 days of stimulation sessions
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Deaths in Each of the 3 Groups Attributable to the Direct Effects of Stroke
We will tabulate the number of deaths in High-dose tDCS, Low-dose tDCS and Sham stimulation groups, that are attributable to the direct effects of the qualifying stroke.
Measured: During the 5 days of stimulation sessions
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Neurological Deterioration in Each of the 3 Groups
We will tabulate the number of participants who develop neurological deterioration in the High-dose tDCS, Low-dose tDCS and Sham groups. Neurological deterioration will be defined as an increase in the total National Institute of Health Stroke Scale (NIHSS) Score by 4 or more points between each successive day. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS ranges from 0 (normal) to 42 (worst possible score). Higher scores mean worse neurological functions.
Measured: During the 5 days of stimulation sessions
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Motor Deterioration in Each of the 3 Groups
We will tabulate the number of participants with deterioration in their motor functions in the High-dose tDCS, Low-dose tDCS and Sham groups. Motor deterioration will be defined as an increase in the motor sub-item of the National Institute of Health Stroke Scale (NIHSS) score by 2 or more points between each successive day of stimulation. The motor sub-item of the NIHSS ranges from 0 (normal) to 16 (worst possible score), with higher scores indicating a worse motor exam.
Measured: During the 5 days of stimulation sessions
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Swallowing Deterioration in Each of the 3 Groups
We will tabulate the number of participants with swallowing deterioration in the High-dose tDCS, Low-dose tDCS and sham groups Swallowing deterioration will be defined as an increase in the score by 2 or more points in the Functional Oral Intake Scale (FOIS). FOIS provides a validated measure of diet level. FOIS is an ordinal scale ranging from 7 (normal diet) to 0 (no oral intake), with lower scores indicating a worse diet.
Measured: Any change between day 1 and day 3 of stimulation session
Secondary outcomes (5)
To Assess and Compare Changes in Dietary Intake in Each of the Three Groups
The durability of any observed effects of the intervention on dietary status will be estimated by changes in Functional Oral Intake Scale (FOIS) score. FOIS is an ordinal scale ranging from 1 (worst) to 7 (normal oral diet) and provides a reliable measure of dietary intake. The change in FOIS scores across each group will be compared.
Measured: At study onset and after 1 month
To Assess Changes in Physiological Measures of Pharyngeal Strength
Examining effects of differing doses of anodal tDCS versus sham stimulation on Pharyngeal Constriction Ratio (PCR), derived from videofluoroscopic swallowing studies.PCR is a measure of the pharyngeal area visible in the lateral radiograph view at the point when a bolus is held in the oral cavity divided by the pharyngeal area at the point of maximum pharyngeal constriction during the swallow. A higher PCR indicates a weak swallow leading to increased food residue in the pharynx.
Measured: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
To Assess Changes in Physiological Measures of Briskness of Swallow Onset
Examining effects of differing doses of anodal tDCS versus sham stimulation on Pharyngeal Delay Time (PDT) , derived from videofluoroscopic swallowing studies. PDT is defined as the time in centiseconds that the bolus is present in the hypopharynx before the swallow is triggered. PDT is a temporal measure of the briskness of the swallow onset.
Measured: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
To Assess Changes in Physiological Measures of Laryngeal Excursion
Examining effects of differing doses of anodal tDCS versus sham stimulation on measure of actual excursion of the larynx in centimeters from their resting point to maximal excursion, derived from videofluoroscopic swallowing studies.
Measured: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
Change in PAS Scores as an Indicator of Dysphagia Recovery After Covariate Adjustment
We will examine the effects of the intervention in a linear model by using it as a predictor for dysphagia recovery along with other variables of interest [age, baseline National Institute of Health Stroke Scale and Penetration and Aspiration Scale (PAS) scores], with a change in PAS scores from baseline to day 5 of the intervention, as being the outcome of interest.
Measured: At day 5 of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startSep 2013
- Primary completion31 May 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Parallel groups
- Model description
- The trial will randomize subjects to anodal transcranial direct current stimulation (tDCS) versus sham stimulation, both of them carried out in combination with standardized swallowing exercises
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Sandeep Kumar, Beth Israel Deaconess Medical Center
- Investigators
- Sandeep Kumar, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919112
- Sponsor's protocol ID
- 2013P000067
- Other IDs
- 1R01DC012584-01A1
- Acronym
- FEASt
- Status last verified
- Jul 2020
- First submitted
- 6 Aug 2013
- Last updated
- 21 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Marchina S, Schlaug G, Kumar S. Study design for the fostering eating after stroke with transcranial direct current stimulation trial: a randomized controlled intervention for improving Dysphagia after acute ischemic stroke. J Stroke Cerebrovasc Dis. 2015 Mar;24(3):511-20. doi: 10.1016/j.jstrokecerebrovasdis.2014.09.027. Epub 2014 Dec 19.
PubMed 25534369
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation for Swallowing Recovery After a Dysphagic Stroke
- ClinicalTrials.gov ID
- NCT01919112
- Acronym / sponsor ID
- FEASt / 2013P000067
- Keywords
- Brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Sep 2013 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Swallowing difficulties are common after a stroke and can lead to serious complications like pneumonia and malnutrition. Unfortunately, there are no effective treatment for improving swallowing in stroke patients.
Previous investigations have shown that recovery of swallowing functions occurs from reorganization ("rewiring") of the non-involved cerebral hemisphere. In this study, the investigators propose to investigate a new intervention, which combines, swallowing exercises with brain stimulation targeted to the non-involved cerebral hemisphere, using low intensity current in acute stroke patients. The investigators plan to assess the safety of this technique in this patient population and also assess its effect on improving swallowing functions and swallowing physiology. During this time trial participants will undergo standardized swallowing and neurological assessments as well as brain MRI scans.
Detailed description
Swallowing impairments are a common and a serious complication of stroke but lack effective therapies. The study investigators herein propose to conduct a prospective clinical study using a non-invasive brain stimulation technique, anodal transcranial direct current stimulation (tDCS), in combination with swallowing exercises for improving dysphagia due to an acute-subacute hemispheric infarction, and obtain data on safety and effect of 2 different doses of tDCS, on swallowing physiology and behavior. Dysphagia from hemispheric strokes occurs due to disruption of the cortical projections to the brainstem swallowing centers while recovery of swallowing functions have been shown to be mediated via the reorganization of the swallowing cortex in the unaffected hemisphere. A recent pilot study conducted by the investigators demonstrated the safety and feasibility of applying 5 consecutive daily sessions of anodal tDCS for 30 minutes to the swallowing cortex on the unaffected hemisphere in the acute-subacute stroke phases and showed a promise in improving dysphagia, when combined with swallowing exercises. The proposed research will be used to further confirm safety of this technique in early stroke phases and explore alternative, more effective doses for promoting swallowing recovery prior to its examination in any confirmatory trials. The investigators will use the study cohort to examine important subject specific parameters which influence response to the proposed intervention in dysphagic stroke patients. The overall aim of this study is to gather additional safety data on cumulative sessions of tDCS in acute-subacute phases of stroke, obtain information about effects of this intervention on important physiological and clinically relevant swallowing parameters, examine possible dose effects, and identify candidates who are more likely to benefit from this intervention. The experience gained from this project will guide planning of future confirmatory trials that use relevant clinical outcomes to assess potential benefits of this intervention and utilize important subject specific parameters to refine study inclusion criteria and aid in severity adjusted analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The trial will randomize subjects to anodal transcranial direct current stimulation (tDCS) versus sham stimulation, both of them carried out in combination with standardized swallowing exercises
| Arm | Type | Receives |
|---|---|---|
| High dose anodal tDCS | Experimental | Device: tDCSHigh dose tDCS (2 milliamps twice daily) for 5 days will be administered concomitantly with swallowing exercises |
| Low dose anodal tDCS | Active comparator | Device: tDCSThis arm will use a low dose of current administered via tDCS (2 milliamps once daily) for 5 days will be administered concomitantly with swallowing exercises |
| Sham Stimulation | Sham comparator | Device: tDCSTwice daily swallowing exercises only |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 21 years or older in age since safety of non-invasive cortical stimulation in children.
- Between 25 hours (day 2) to 144 (day 6) hours since stroke onset.
- Unilateral hemispheric infarction (cortical or subcortical infarction) documented by imaging.
- Moderate to severe dysphagia with a score of 4 or more on Penetration and Aspiration Scale (PAS)
Key exclusion criteria (4 listed)
- Prior history of swallowing difficulties.
- Drowsiness or marked cognitive impairment that interferes with participation in swallowing maneuvers.
- Unable to undergo an MRI due to claustrophobia or presence of electrically, magnetically or mechanically activated implant (including cardiac pacemaker), intracerebral vascular clips or any other electrically sensitive support system, metal in any part of the body, including metallic injury to eye, or pregnancy).
- History of seizures or unexplained episodes of loss of consciousness.
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 |
|---|---|---|
| tDCSAnodal tDCS will be administered with swallowing exercises | Device | High dose anodal tDCS, Low dose anodal tDCS, Sham Stimulation |
Primary outcome
To Assess Changes in Penetration and Aspiration
Time frame: Scores will be measured before tDCS and after 5 days after completion of stimulation
This will be assessed using the Penetration and Aspiration Scale (PAS) scores, a validated 8 point ordinal scale that quantifies penetration and aspiration events observed during Videofluoroscopic Swallowing Evaluation. PAS ranges from 1 (best score) representing no aspiration or penetration to 8 (worst score) representing severe aspiration. An average PAS score will be computed based on 9 swallows for this outcome.
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Seizures in Each of the 3 Groups
Time frame: During the 5 days of stimulation sessions
We will tabulate the number of participants who develop seizures in the High-dose anodal tDCS, Low-dose anodal tDCS and Sham stimulation groups.
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Deaths in Each of the 3 Groups Attributable to the Direct Effects of Stroke
Time frame: During the 5 days of stimulation sessions
We will tabulate the number of deaths in High-dose tDCS, Low-dose tDCS and Sham stimulation groups, that are attributable to the direct effects of the qualifying stroke.
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Neurological Deterioration in Each of the 3 Groups
Time frame: During the 5 days of stimulation sessions
We will tabulate the number of participants who develop neurological deterioration in the High-dose tDCS, Low-dose tDCS and Sham groups. Neurological deterioration will be defined as an increase in the total National Institute of Health Stroke Scale (NIHSS) Score by 4 or more points between each successive day. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS ranges from 0 (normal) to 42 (worst possible score). Higher scores mean worse neurological functions.
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Motor Deterioration in Each of the 3 Groups
Time frame: During the 5 days of stimulation sessions
We will tabulate the number of participants with deterioration in their motor functions in the High-dose tDCS, Low-dose tDCS and Sham groups. Motor deterioration will be defined as an increase in the motor sub-item of the National Institute of Health Stroke Scale (NIHSS) score by 2 or more points between each successive day of stimulation. The motor sub-item of the NIHSS ranges from 0 (normal) to 16 (worst possible score), with higher scores indicating a worse motor exam.
To Assess Safety of tDCS in Acute-subacute Stroke Phase: Number of Participants With Swallowing Deterioration in Each of the 3 Groups
Time frame: Any change between day 1 and day 3 of stimulation session
We will tabulate the number of participants with swallowing deterioration in the High-dose tDCS, Low-dose tDCS and sham groups Swallowing deterioration will be defined as an increase in the score by 2 or more points in the Functional Oral Intake Scale (FOIS). FOIS provides a validated measure of diet level. FOIS is an ordinal scale ranging from 7 (normal diet) to 0 (no oral intake), with lower scores indicating a worse diet.
5 secondary outcomes
To Assess and Compare Changes in Dietary Intake in Each of the Three Groups
Time frame: At study onset and after 1 month
To Assess Changes in Physiological Measures of Pharyngeal Strength
Time frame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
To Assess Changes in Physiological Measures of Briskness of Swallow Onset
Time frame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
To Assess Changes in Physiological Measures of Laryngeal Excursion
Time frame: Variables will be measured at baseline (before starting tDCS) and after 5 days after completion of stimulation
Change in PAS Scores as an Indicator of Dysphagia Recovery After Covariate Adjustment
Time frame: At day 5 of study participation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25534369Marchina S, Schlaug G, Kumar S. Study design for the fostering eating after stroke with transcranial direct current stimulation trial: a randomized controlled intervention for improving Dysphagia after acute ischemic stroke. J Stroke Cerebrovasc Dis. 2015 Mar;24(3):511-20. doi: 10.1016/j.jstrokecerebrovasdis.2014.09.027. Epub 2014 Dec 19.
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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.
Sandeep Kumar, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Dysphagia and Stroke, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Assess Changes in Penetration and Aspiration (time frame: Scores will be measured before tDCS and after 5 days after completion of stimulation). The study lists 6 primary outcomes in all. 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 NCT01919112, 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 21 Jul 2020.