StrokeNCT04431362
Effects of Music Listening on Mood in an Inpatient Rehabilitation
A study testing Self-selected music in people with Stroke, run by King's College Hospital NHS Trust.
Trial summary
The aim is to examine whether self-selected music can improve mood (as well as cognitive function) in stroke patients at an inpatient rehabilitation unit. Additionally, the feasibility of such an intervention will be assessed. Hypotheses: The current intervention will be found to have a high feasibility. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Self-selected music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to Dec 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Good grasp of the English Language
- Patients at the Frank Cooksey Rehabilitation Unit or transferring to the unit from an acute stroke ward
- Recent diagnosis of stroke using MRI or CT scans
- Low mood; will be confirmed by the clinical psychologist on the ward using mood screens as appropriate
- Exclusion Criteria:- Severe or global aphasia, which interferes with their ability to understand instructions
Show all 9Show fewer
- Have a diagnosis of dementia
- Patients who lack the capacity to consent
- The study will also aim to exclude patients who have severe cognitive impairment, as assessed by the occupational therapists and clinical psychologist on the ward using screens or functional assessment as appropriate.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Case Experimental Design Study Exploring the Effect of Music in an Inpatient Neuropsychological Rehabilitation Setting
The aim is to examine whether self-selected music can improve mood (as well as cognitive function) in stroke patients at an inpatient rehabilitation unit. Additionally, the feasibility of such an intervention will be assessed.
Hypotheses:
- The current intervention will be found to have a high feasibility.
- Stroke patients will exhibit improved mood during the music listening intervention phase compared to their baseline phase.
- Patients will show improvements in engagement in therapy if non-compliance was a previous issue (as demonstrated by therapist feedback regarding attendance of therapy sessions).
- Patients will experience improved cognitive (memory) function (i.e. immediate and delayed free recall) during the intervention phase compared to baseline.
Read the detailed description
Stroke is one of the leading causes of disability in the world. Research has shown that in the aftermath of a stroke, patients continue to experience various impairments even years after the stroke. For example, research has shown that stroke survivors continue to experience both cognitive impairments (e.g. executive dysfunction) and low mood (e.g. depression) even after more than 5 years since the stroke has passed. A further study was able to link low mood with reduced engagement in therapy, which has been found to lead patients to experience less benefits from the given therapy.
Due to the lack of supporting evidence for pharmacological and psychological treatments, music intervention was introduced with positive results being reported in regards to patients' mood and cognitive abilities. For example, one study found that stroke patients who listened to self-selected music were likely to experience a significant improvement in their mood and cognitive abilities when compared to another group who listened to audiobooks.
The current study aims to build on previous research by utilising a novel study design that has not been previously used to assess the feasibility and effectiveness of music intervention on the mood of patients located at an inpatient rehabilitation unit. The chosen design, single-case experimental design, allows researchers to take into account the individual differences of the patients, which cannot be considered when using an experimental design which needs a group of similar characteristics. In addition, by using a non-concurrent multiple baseline design, the researchers will be able to show that any changes occurring to the target behaviour (mood) will be due to the intervention itself rather than any other extraneous variables found in the environment, as three different time lengths will be used for the baseline phase (5, 10, and 15 days). The aim of the study is to provide data that support the feasibility and effectiveness of music intervention as an inexpensive and simple method for improving mood in stroke patients at an inpatient rehabilitation unit. It also aims to show similar effectiveness in increasing cognitive impairment and therapy engagement.
- Conditions
- Stroke
- Being tested
- Self-selected music
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-selected musicBehavioural
Participants will be given iPods and headphones to listen to their music
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Participants will not listen to music for 5 to 15 days based on the baseline duration they were assigned. |
| Intervention | Experimental | Participants will listen to music for 3 weeks. Receives: Behavioral: Self-selected music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the CORE-10 mood screen
questionnaire measure of distress, functioning and risk
Measured: up to 6 weeks
Change in self-report diary
will assess feasibility by examining how frequently the patients are listening to music
Measured: up to 6 weeks
Change in self-report by therapists
Will help to assess patients' engagement in therapy before during and after intervention
Measured: up to 6 weeks
Change in the Montreal Cognitive Assessment
Will help to explore changes in cognition before and after the intervention. Minimum value=0, maximum value=30, better scores mean better outcome.
Measured: up to 6 weeks
Change in The Brain Injury Rehabilitation Trust Memory and Information Processing Battery (examines memory and information processing. Only the story recall subcategory will be used)
Will help to explore changes in cognition (memory) before and after the intervention Minimum value=0, maximum value=60. Better scores mean better outcome
Measured: up to 6 weeks
Change in the Mood Likert Scale
Ad hoc scale made for the study for participants to rate their mood. It is a Likert scale (0 is very relaxed, 10 is very stressed). Higher score thus mean worse outcome.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Mar 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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
- Participants first complete a baseline phase before starting the intervention phase.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Giulia Bellesi, DClinPsy, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431362
- Sponsor's protocol ID
- 261210
- Status last verified
- Feb 2021
- First submitted
- 26 Apr 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adamson J, Beswick A, Ebrahim S. Is stroke the most common cause of disability? J Stroke Cerebrovasc Dis. 2004 Jul-Aug;13(4):171-7. doi: 10.1016/j.jstrokecerebrovasdis.2004.06.003.
PubMed 17903971Dallery J, Cassidy RN, Raiff BR. Single-case experimental designs to evaluate novel technology-based health interventions. J Med Internet Res. 2013 Feb 8;15(2):e22. doi: 10.2196/jmir.2227.
PubMed 23399668Hammond MF, O'Keeffe ST, Barer DH. Development and validation of a brief observer-rated screening scale for depression in elderly medical patients. Age Ageing. 2000 Nov;29(6):511-5. doi: 10.1093/ageing/29.6.511.
PubMed 11191243Koorenhof L, Baxendale S, Smith N, Thompson P. Memory rehabilitation and brain training for surgical temporal lobe epilepsy patients: a preliminary report. Seizure. 2012 Apr;21(3):178-82. doi: 10.1016/j.seizure.2011.12.001. Epub 2011 Dec 23.
PubMed 22197200Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
PubMed 29253607Ouellet MC, Morin CM. Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design. Arch Phys Med Rehabil. 2007 Dec;88(12):1581-92. doi: 10.1016/j.apmr.2007.09.006.
PubMed 18047872Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Aphasiology. 2016 Jul 2;30(7):862-876. doi: 10.1080/02687038.2016.1178022. Epub 2016 Apr 29.
PubMed 27279674Tunnard C, Wilson BA. Comparison of neuropsychological rehabilitation techniques for unilateral neglect: an ABACADAEAF single-case experimental design. Neuropsychol Rehabil. 2014;24(3-4):382-99. doi: 10.1080/09602011.2013.872041. Epub 2014 Jan 13.
PubMed 24410191Ayerbe L, Ayis S, Wolfe CD, Rudd AG. Natural history, predictors and outcomes of depression after stroke: systematic review and meta-analysis. Br J Psychiatry. 2013 Jan;202(1):14-21. doi: 10.1192/bjp.bp.111.107664.
PubMed 23284148Baylan S, McGinlay M, MacDonald M, Easto J, Cullen B, Haig C, Mercer SW, Murray H, Quinn TJ, Stott D, Broomfield NM, Stiles C, Evans JJ. Participants' experiences of music, mindful music, and audiobook listening interventions for people recovering from stroke. Ann N Y Acad Sci. 2018 May 4. doi: 10.1111/nyas.13618. Online ahead of print.
PubMed 29727009Baylan S, Swann-Price R, Peryer G, Quinn T. The effects of music listening interventions on cognition and mood post-stroke: a systematic review. Expert Rev Neurother. 2016 Nov;16(11):1241-1249. doi: 10.1080/14737175.2016.1227241. Epub 2016 Aug 29.
PubMed 27548875Cumming TB, Churilov L, Linden T, Bernhardt J. Montreal Cognitive Assessment and Mini-Mental State Examination are both valid cognitive tools in stroke. Acta Neurol Scand. 2013 Aug;128(2):122-9. doi: 10.1111/ane.12084. Epub 2013 Feb 21.
PubMed 23425001Maclean N, Pound P, Wolfe C, Rudd A. Qualitative analysis of stroke patients' motivation for rehabilitation. BMJ. 2000 Oct 28;321(7268):1051-4. doi: 10.1136/bmj.321.7268.1051.
PubMed 11053175McKevitt C, Fudge N, Redfern J, Sheldenkar A, Crichton S, Rudd AR, Forster A, Young J, Nazareth I, Silver LE, Rothwell PM, Wolfe CD. Self-reported long-term needs after stroke. Stroke. 2011 May;42(5):1398-403. doi: 10.1161/STROKEAHA.110.598839. Epub 2011 Mar 24.
PubMed 21441153Sarkamo T, Tervaniemi M, Laitinen S, Forsblom A, Soinila S, Mikkonen M, Autti T, Silvennoinen HM, Erkkila J, Laine M, Peretz I, Hietanen M. Music listening enhances cognitive recovery and mood after middle cerebral artery stroke. Brain. 2008 Mar;131(Pt 3):866-76. doi: 10.1093/brain/awn013.
PubMed 18287122
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Case Experimental Design Study Exploring the Effect of Music in an Inpatient Neuropsychological Rehabilitation Setting
- ClinicalTrials.gov ID
- NCT04431362
- Acronym / sponsor ID
- 261210
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to examine whether self-selected music can improve mood (as well as cognitive function) in stroke patients at an inpatient rehabilitation unit. Additionally, the feasibility of such an intervention will be assessed.
Hypotheses:
- The current intervention will be found to have a high feasibility.
- Stroke patients will exhibit improved mood during the music listening intervention phase compared to their baseline phase.
- Patients will show improvements in engagement in therapy if non-compliance was a previous issue (as demonstrated by therapist feedback regarding attendance of therapy sessions).
- Patients will experience improved cognitive (memory) function (i.e. immediate and delayed free recall) during the intervention phase compared to baseline.
Detailed description
Stroke is one of the leading causes of disability in the world. Research has shown that in the aftermath of a stroke, patients continue to experience various impairments even years after the stroke. For example, research has shown that stroke survivors continue to experience both cognitive impairments (e.g. executive dysfunction) and low mood (e.g. depression) even after more than 5 years since the stroke has passed. A further study was able to link low mood with reduced engagement in therapy, which has been found to lead patients to experience less benefits from the given therapy.
Due to the lack of supporting evidence for pharmacological and psychological treatments, music intervention was introduced with positive results being reported in regards to patients' mood and cognitive abilities. For example, one study found that stroke patients who listened to self-selected music were likely to experience a significant improvement in their mood and cognitive abilities when compared to another group who listened to audiobooks.
The current study aims to build on previous research by utilising a novel study design that has not been previously used to assess the feasibility and effectiveness of music intervention on the mood of patients located at an inpatient rehabilitation unit. The chosen design, single-case experimental design, allows researchers to take into account the individual differences of the patients, which cannot be considered when using an experimental design which needs a group of similar characteristics. In addition, by using a non-concurrent multiple baseline design, the researchers will be able to show that any changes occurring to the target behaviour (mood) will be due to the intervention itself rather than any other extraneous variables found in the environment, as three different time lengths will be used for the baseline phase (5, 10, and 15 days). The aim of the study is to provide data that support the feasibility and effectiveness of music intervention as an inexpensive and simple method for improving mood in stroke patients at an inpatient rehabilitation unit. It also aims to show similar effectiveness in increasing cognitive impairment and therapy engagement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants first complete a baseline phase before starting the intervention phase.
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Participants will not listen to music for 5 to 15 days based on the baseline duration they were assigned. |
| Intervention | Experimental | Behavioral: Self-selected musicParticipants will listen to music for 3 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Good grasp of the English Language
- Patients at the Frank Cooksey Rehabilitation Unit or transferring to the unit from an acute stroke ward
- Recent diagnosis of stroke using MRI or CT scans
- Low mood; will be confirmed by the clinical psychologist on the ward using mood screens as appropriate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Self-selected musicParticipants will be given iPods and headphones to listen to their music | Behavioural | Intervention |
Primary outcome
Change in the CORE-10 mood screen
Time frame: up to 6 weeks
questionnaire measure of distress, functioning and risk
Change in self-report diary
Time frame: up to 6 weeks
will assess feasibility by examining how frequently the patients are listening to music
Change in self-report by therapists
Time frame: up to 6 weeks
Will help to assess patients' engagement in therapy before during and after intervention
Change in the Montreal Cognitive Assessment
Time frame: up to 6 weeks
Will help to explore changes in cognition before and after the intervention. Minimum value=0, maximum value=30, better scores mean better outcome.
Change in The Brain Injury Rehabilitation Trust Memory and Information Processing Battery (examines memory and information processing. Only the story recall subcategory will be used)
Time frame: up to 6 weeks
Will help to explore changes in cognition (memory) before and after the intervention Minimum value=0, maximum value=60. Better scores mean better outcome
Change in the Mood Likert Scale
Time frame: up to 6 weeks
Ad hoc scale made for the study for participants to rate their mood. It is a Likert scale (0 is very relaxed, 10 is very stressed). Higher score thus mean worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Background: PubMed 17903971Adamson J, Beswick A, Ebrahim S. Is stroke the most common cause of disability? J Stroke Cerebrovasc Dis. 2004 Jul-Aug;13(4):171-7. doi: 10.1016/j.jstrokecerebrovasdis.2004.06.003.
- Background: PubMed 23399668Dallery J, Cassidy RN, Raiff BR. Single-case experimental designs to evaluate novel technology-based health interventions. J Med Internet Res. 2013 Feb 8;15(2):e22. doi: 10.2196/jmir.2227.
- Background: PubMed 11191243Hammond MF, O'Keeffe ST, Barer DH. Development and validation of a brief observer-rated screening scale for depression in elderly medical patients. Age Ageing. 2000 Nov;29(6):511-5. doi: 10.1093/ageing/29.6.511.
- Background: PubMed 22197200Koorenhof L, Baxendale S, Smith N, Thompson P. Memory rehabilitation and brain training for surgical temporal lobe epilepsy patients: a preliminary report. Seizure. 2012 Apr;21(3):178-82. doi: 10.1016/j.seizure.2011.12.001. Epub 2011 Dec 23.
- Background: PubMed 29253607Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
- Background: PubMed 18047872Ouellet MC, Morin CM. Efficacy of cognitive-behavioral therapy for insomnia associated with traumatic brain injury: a single-case experimental design. Arch Phys Med Rehabil. 2007 Dec;88(12):1581-92. doi: 10.1016/j.apmr.2007.09.006.
- Background: PubMed 27279674Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Aphasiology. 2016 Jul 2;30(7):862-876. doi: 10.1080/02687038.2016.1178022. Epub 2016 Apr 29.
- Background: PubMed 24410191Tunnard C, Wilson BA. Comparison of neuropsychological rehabilitation techniques for unilateral neglect: an ABACADAEAF single-case experimental design. Neuropsychol Rehabil. 2014;24(3-4):382-99. doi: 10.1080/09602011.2013.872041. Epub 2014 Jan 13.
- Results publication: PubMed 23284148Ayerbe L, Ayis S, Wolfe CD, Rudd AG. Natural history, predictors and outcomes of depression after stroke: systematic review and meta-analysis. Br J Psychiatry. 2013 Jan;202(1):14-21. doi: 10.1192/bjp.bp.111.107664.
- Results publication: PubMed 29727009Baylan S, McGinlay M, MacDonald M, Easto J, Cullen B, Haig C, Mercer SW, Murray H, Quinn TJ, Stott D, Broomfield NM, Stiles C, Evans JJ. Participants' experiences of music, mindful music, and audiobook listening interventions for people recovering from stroke. Ann N Y Acad Sci. 2018 May 4. doi: 10.1111/nyas.13618. Online ahead of print.
- Results publication: PubMed 27548875Baylan S, Swann-Price R, Peryer G, Quinn T. The effects of music listening interventions on cognition and mood post-stroke: a systematic review. Expert Rev Neurother. 2016 Nov;16(11):1241-1249. doi: 10.1080/14737175.2016.1227241. Epub 2016 Aug 29.
- Results publication: PubMed 23425001Cumming TB, Churilov L, Linden T, Bernhardt J. Montreal Cognitive Assessment and Mini-Mental State Examination are both valid cognitive tools in stroke. Acta Neurol Scand. 2013 Aug;128(2):122-9. doi: 10.1111/ane.12084. Epub 2013 Feb 21.
- Neuro-rehabilitation beds openLink provided by the sponsor.
- Assessing capacityLink provided by the sponsor.
- Frank Cooksey Rehabilitation UnitLink provided by the sponsor.
- StrokeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Giulia Bellesi, DClinPsy principal investigator
King's College Hospital NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Self-selected music in people with Stroke, run by King's College Hospital NHS Trust.
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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giulia Bellesi, DClinPsy (01689866391, giulia.bellesi@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the CORE-10 mood screen (time frame: up to 6 weeks). 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 NCT04431362, which also lists 16 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 24 Feb 2021.