Attention Deficit Hyperactivity DisorderNCT04112082
Efficacy of Mobile Neurofeedback for Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
A study testing Mobile Neurofeedback and Treatment as Usual in people with Attention Deficit Hyperactivity Disorder, run by Sheba Medical Center.
Trial summary
This study is an assessor-blind, parallel-group, controlled trial to evaluate the benefit of home-based training with a low-cost, mobile neurofeedback system (Myndlift) in adults with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Mobile Neurofeedback and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2019to Jun 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- willingness to provide consent
- diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) of any type as ascertained by clinical interview conducted by a board-certified psychiatrist
- at the time of enrollment, not receiving treatment for symptoms of ADHD
Who cannot join
- comorbid psychotic or bipolar disorder or an active affective disorder
- medical disorder with potentially confounding psychiatric effects (either due to direct effects of the condition or medication effects)
- diagnosis of substance abuse disorder (SUD), sleep apnea, restless legs syndrome (RLS), or borderline intellectual functioning
- unable to attend in-clinic follow-up assessment
- antipsychotic agent in the three months prior to baseline assessment
- any selective serotonin reuptake inhibitor (SSRI) treatment in the four weeks prior to baseline
Show all 9Show fewer
- other psychiatric medication in the two weeks prior to baseline that the principal investigator deems to be confounding
- experimental group only: plans to start stimulant medication during the course of the study (use of nutritional supplements including "prescription medical foods" is not exclusionary)
- neurofeedback treatment in the two years prior to baseline
Trial locations and contacts
No sites are listed yet.
About this study
This study is an assessor-blind, parallel-group, controlled trial to evaluate the benefit of home-based training with a low-cost, mobile neurofeedback system (Myndlift) in adults with ADHD. Randomized controlled trials have shown significant benefit for neurofeedback, including persistent effects without the side effects of psychostimulants (i.e., diminished appetite, insomnia, anxiety, irritability). However, standard application requires clinic visits and significant expense, limiting training frequency and compromising potential efficacy. Additionally, extant evidence for efficacy comes almost exclusively from children and adolescents, with very few studies in adults. The present trial will measure the ability of home-based neurofeedback using a low-cost, user-friendly system to ameliorate symptomatology (e.g., enhancing attention, reducing impulsive behavior) in adults with ADHD. Participants will receive either neurofeedback or treatment as usual (TAU). Primary outcomes will be objective scores on a continuous performance task (CPT) and subjective report on a standardized adult ADHD symptoms questionnaire. Eligible participants recruited from an adult ADHD clinic will complete a baseline assessment (1.25 hours) including subjective questionnaires, computerized cognitive assessment, and resting-state EEG administered by a blinded assessor. The experimental group will train at home with a neurofeedback headset and tablet 4 times/week for ten weeks (session duration: 21-30 minutes). Neurofeedback will be provided via a conventional theta beta protocol in which participants train using gamified tasks, videos, or audio clips in a tablet-based app, and receive positive visual/auditory feedback when their brainwaves are in the desired range. The control group will follow the regular treatment plan set by the clinic (i.e., treatment as usual; TAU). Care may include pharmacological intervention, cognitive behavioral therapy (CBT), a combination of both, or no intervention. Care will often include pharmacological intervention (e.g., methylphenidate), with the specifics (e.g., type of medication, dosage) determined by psychiatrist recommendation. After completing the ten-week intervention period, all participants will return to the clinic for a follow-up assessment identical to the baseline assessment. It is hypothesized that home-based neurofeedback training will demonstrate non-inferiority to TAU as measured by improvement in subjective and objective symptoms.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Mobile Neurofeedback, Treatment as Usual
- Keywords
- neurofeedback, Attention Deficit Hyperactivity Disorder (ADHD), attention, executive function, electroencephalogram (EEG), adult ADHD, wearable sensors
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile NeurofeedbackBehavioural
Also called neurotherapy, electroencephalogram (EEG) biofeedback, brainwave biofeedback
Home-based neurofeedback training (downtrain theta, uptrain beta; training site: Cz) 4 times weekly for a 40 of total sessions over the ten-week training period. Session duration of 21 minutes for the first 20 sessions to 30 minutes for the last 20 sessions. Positive visual and auditory feedback when brainwaves are within the desired range.
Treatment as UsualOther
Treatment plan as part of regular care at the ADHD clinic, which may include pharmacological intervention, cognitive behavioral therapy (CBT), a combination of pharmacological intervention and CBT, or no intervention. Care will often include pharmacological intervention, with the specifics (e.g., type of medication, dosage) determined by psychiatrist recommendation considering such factors as response to previous interventions, participant characteristics, and practical constraints. Most pharmacological interventions will be stimulants (e.g., methylphenidate) with various release mechanisms. Each participant will receive an individualized dose titration and follow-up plan, including clinic visits as needed (generally 1-2 visits over the 10-week intervention period); interventions may be switched in accord with clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| Home-Based Neurofeedback Training | Experimental | Not described Receives: Behavioral: Mobile Neurofeedback |
| Treatment as Usual | Active comparator | Not described Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Continuous Performance Task (CPT) Response Time
mean response time for correct responses on a computerized CPT
Measured: baseline, immediately after 10-week intervention period
Change in Continuous Performance Task (CPT) Response Time Variability
standard deviation of response time for correct responses on a computerized CPT
Measured: baseline, immediately after 10-week intervention period
Change in Self-Reported ADHD Symptoms
total score on the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1)
Measured: baseline, immediately after 10-week intervention period
Secondary outcomes (13)
EEG Theta Amplitude
resting state fronto-central theta amplitude
Measured: baseline, immediately after 10-week intervention period
EEG Beta Amplitude
resting state fronto-central beta amplitude
Measured: baseline, immediately after 10-week intervention period
EEG Theta/Beta Ratio
resting state fronto-central theta/beta ratio
Measured: baseline, immediately after 10-week intervention period
Continuous Performance Task (CPT) Accuracy
percent correct on a computerized CPT
Measured: baseline, immediately after 10-week intervention period
Continuous Performance Task (CPT) Commission Errors
number of commission errors on a computerized CPT
Measured: baseline, immediately after 10-week intervention period
Continuous Performance Task (CPT) Omission Errors
number of commission errors on a computerized CPT
Measured: baseline, immediately after 10-week intervention period
ADHD Screener Score
sum of item scores for the first 6 items (Part A) of the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1); item ratings: 0=never, 1=rarely, 2=sometimes, 3=often, 4=very often; scoring: for items 1-3, ratings of sometimes, often, or very often are assigned one point; for items 4-6 ratings of often or very often are assigned one point; a higher score reflects a worse outcome
Measured: baseline, immediately after 10-week intervention period
ADHD Symptom Inattention Subtype Score
sum of item scores for the 9 inattention items from the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1): items 1-4 \& 7-11; item ratings: 0=never, 1=rarely, 2=sometimes, 3=often, 4=very often; scoring: for items 1-3 \& 9, ratings of sometimes, often, or very often are assigned one point; for items 4, 7, 8, 10 \& 11, ratings of often or very often are assigned one point; a higher score reflects a worse outcome
Measured: baseline, immediately after 10-week intervention period
ADHD Symptom Hyperactivity/Impulsivity Subtype Score
sum of item scores for the 9 hyperactivity/impulsivity items from the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1): items 5-6 \& 12-18; item ratings: 0=never, 1=rarely, 2=sometimes, 3=often, 4=very often; scoring: for items 12 \& 18, ratings of sometimes, often, or very often are assigned one point; for items 5-6 \& 13-17, ratings of often or very often are assigned one point; a higher score reflects a worse outcome
Measured: baseline, immediately after 10-week intervention period
Global Cognitive Score from Cognitive Battery
global cognitive score (average of standardized domain scores) from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation: 15
Measured: baseline, immediately after 10-week intervention period
Attention Domain Score from Cognitive Battery
standardized attention domain score from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation 15
Measured: baseline, immediately after 10-week intervention period
Executive Function Domain Score from Cognitive Battery
standardized executive function domain score from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation 15
Measured: baseline, immediately after 10-week intervention period
Information Processing Speed Domain Score from Cognitive Battery
standardized information processing speed domain score from a computerized cognitive battery; scale: age- and education-adjusted mean: 100; standard deviation 15
Measured: baseline, immediately after 10-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start22 Dec 2019 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Sheba 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Myndlift Ltd.
- Responsible party
- Principal investigator, Dr. Tamir Epstein, Sheba Medical Center
- Investigators
- Tamir Epstein, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04112082
- Sponsor's protocol ID
- 6362-19-SMC
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
PubMed 16923651Brod M, Johnston J, Able S, Swindle R. Validation of the adult attention-deficit/hyperactivity disorder quality-of-life Scale (AAQoL): a disease-specific quality-of-life measure. Qual Life Res. 2006 Feb;15(1):117-29. doi: 10.1007/s11136-005-8325-z.
PubMed 16411036Schweiger A, Abramovitch A, Doniger GM, Simon ES. A clinical construct validity study of a novel computerized battery for the diagnosis of ADHD in young adults. J Clin Exp Neuropsychol. 2007 Jan;29(1):100-11. doi: 10.1080/13803390500519738.
PubMed 17162726Micoulaud-Franchi JA, Geoffroy PA, Fond G, Lopez R, Bioulac S, Philip P. EEG neurofeedback treatments in children with ADHD: an updated meta-analysis of randomized controlled trials. Front Hum Neurosci. 2014 Nov 13;8:906. doi: 10.3389/fnhum.2014.00906. eCollection 2014.
PubMed 25431555Arns M, de Ridder S, Strehl U, Breteler M, Coenen A. Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta-analysis. Clin EEG Neurosci. 2009 Jul;40(3):180-9. doi: 10.1177/155005940904000311.
PubMed 19715181Riesco-Matias P, Yela-Bernabe JR, Crego A, Sanchez-Zaballos E. What Do Meta-Analyses Have to Say About the Efficacy of Neurofeedback Applied to Children With ADHD? Review of Previous Meta-Analyses and a New Meta-Analysis. J Atten Disord. 2021 Feb;25(4):473-485. doi: 10.1177/1087054718821731. Epub 2019 Jan 15.
PubMed 30646779
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mobile Neurofeedback for Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT04112082
- Acronym / sponsor ID
- 6362-19-SMC
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- neurofeedback, Attention Deficit Hyperactivity Disorder (ADHD), attention, executive function, electroencephalogram (EEG), adult ADHD, wearable sensors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Myndlift Ltd.
- Study start
- 22 Dec 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 2 Oct 2019 (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.
This study is an assessor-blind, parallel-group, controlled trial to evaluate the benefit of home-based training with a low-cost, mobile neurofeedback system (Myndlift) in adults with ADHD. Randomized controlled trials have shown significant benefit for neurofeedback, including persistent effects without the side effects of psychostimulants (i.e., diminished appetite, insomnia, anxiety, irritability). However, standard application requires clinic visits and significant expense, limiting training frequency and compromising potential efficacy. Additionally, extant evidence for efficacy comes almost exclusively from children and adolescents, with very few studies in adults. The present trial will measure the ability of home-based neurofeedback using a low-cost, user-friendly system to ameliorate symptomatology (e.g., enhancing attention, reducing impulsive behavior) in adults with ADHD. Participants will receive either neurofeedback or treatment as usual (TAU). Primary outcomes will be objective scores on a continuous performance task (CPT) and subjective report on a standardized adult ADHD symptoms questionnaire. Eligible participants recruited from an adult ADHD clinic will complete a baseline assessment (1.25 hours) including subjective questionnaires, computerized cognitive assessment, and resting-state EEG administered by a blinded assessor. The experimental group will train at home with a neurofeedback headset and tablet 4 times/week for ten weeks (session duration: 21-30 minutes). Neurofeedback will be provided via a conventional theta beta protocol in which participants train using gamified tasks, videos, or audio clips in a tablet-based app, and receive positive visual/auditory feedback when their brainwaves are in the desired range. The control group will follow the regular treatment plan set by the clinic (i.e., treatment as usual; TAU). Care may include pharmacological intervention, cognitive behavioral therapy (CBT), a combination of both, or no intervention. Care will often include pharmacological intervention (e.g., methylphenidate), with the specifics (e.g., type of medication, dosage) determined by psychiatrist recommendation. After completing the ten-week intervention period, all participants will return to the clinic for a follow-up assessment identical to the baseline assessment. It is hypothesized that home-based neurofeedback training will demonstrate non-inferiority to TAU as measured by improvement in subjective and objective symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-Based Neurofeedback Training | Experimental | Behavioral: Mobile Neurofeedback |
| Treatment as Usual | Active comparator | Other: Treatment as Usual |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- willingness to provide consent
- diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) of any type as ascertained by clinical interview conducted by a board-certified psychiatrist
- at the time of enrollment, not receiving treatment for symptoms of ADHD
Key exclusion criteria (9 listed)
- comorbid psychotic or bipolar disorder or an active affective disorder
- medical disorder with potentially confounding psychiatric effects (either due to direct effects of the condition or medication effects)
- diagnosis of substance abuse disorder (SUD), sleep apnea, restless legs syndrome (RLS), or borderline intellectual functioning
- unable to attend in-clinic follow-up assessment
- antipsychotic agent in the three months prior to baseline assessment
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 |
|---|---|---|
| Mobile NeurofeedbackAlso: neurotherapy, electroencephalogram (EEG) biofeedback, brainwave biofeedbackHome-based neurofeedback training (downtrain theta, uptrain beta; training site: Cz) 4 times weekly for a 40 of total sessions over the ten-week training period. Session duration of 21 minutes for the first 20 sessions to 30 minutes for the last 20 sessions. Positive visual and auditory feedback when brainwaves are within the desired range. | Behavioural | Home-Based Neurofeedback Training |
| Treatment as UsualTreatment plan as part of regular care at the ADHD clinic, which may include pharmacological intervention, cognitive behavioral therapy (CBT), a combination of pharmacological intervention and CBT, or no intervention. Care will often include pharmacological intervention, with the specifics (e.g., type of medication, dosage) determined by psychiatrist recommendation considering such factors as response to previous interventions, participant characteristics, and practical constraints. Most pharmacological interventions will be stimulants (e.g., methylphenidate) with various release mechanisms. Each participant will receive an individualized dose titration and follow-up plan, including clinic visits as needed (generally 1-2 visits over the 10-week intervention period); interventions may be switched in accord with clinical judgment. | Other | Treatment as Usual |
Primary outcome
Change in Continuous Performance Task (CPT) Response Time
Time frame: baseline, immediately after 10-week intervention period
mean response time for correct responses on a computerized CPT
Change in Continuous Performance Task (CPT) Response Time Variability
Time frame: baseline, immediately after 10-week intervention period
standard deviation of response time for correct responses on a computerized CPT
Change in Self-Reported ADHD Symptoms
Time frame: baseline, immediately after 10-week intervention period
total score on the Adult ADHD Self-Report Scale Symptom Checklist (ASRS-v1.1)
13 secondary outcomes
EEG Theta Amplitude
Time frame: baseline, immediately after 10-week intervention period
EEG Beta Amplitude
Time frame: baseline, immediately after 10-week intervention period
EEG Theta/Beta Ratio
Time frame: baseline, immediately after 10-week intervention period
Continuous Performance Task (CPT) Accuracy
Time frame: baseline, immediately after 10-week intervention period
Continuous Performance Task (CPT) Commission Errors
Time frame: baseline, immediately after 10-week intervention period
Continuous Performance Task (CPT) Omission Errors
Time frame: baseline, immediately after 10-week intervention period
ADHD Screener Score
Time frame: baseline, immediately after 10-week intervention period
ADHD Symptom Inattention Subtype Score
Time frame: baseline, immediately after 10-week intervention period
ADHD Symptom Hyperactivity/Impulsivity Subtype Score
Time frame: baseline, immediately after 10-week intervention period
Global Cognitive Score from Cognitive Battery
Time frame: baseline, immediately after 10-week intervention period
Attention Domain Score from Cognitive Battery
Time frame: baseline, immediately after 10-week intervention period
Executive Function Domain Score from Cognitive Battery
Time frame: baseline, immediately after 10-week intervention period
Information Processing Speed Domain Score from Cognitive Battery
Time frame: baseline, immediately after 10-week intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 16923651Adler LA, Spencer T, Faraone SV, Kessler RC, Howes MJ, Biederman J, Secnik K. Validity of pilot Adult ADHD Self- Report Scale (ASRS) to Rate Adult ADHD symptoms. Ann Clin Psychiatry. 2006 Jul-Sep;18(3):145-8. doi: 10.1080/10401230600801077.
- Background: PubMed 16411036Brod M, Johnston J, Able S, Swindle R. Validation of the adult attention-deficit/hyperactivity disorder quality-of-life Scale (AAQoL): a disease-specific quality-of-life measure. Qual Life Res. 2006 Feb;15(1):117-29. doi: 10.1007/s11136-005-8325-z.
- Background: PubMed 17162726Schweiger A, Abramovitch A, Doniger GM, Simon ES. A clinical construct validity study of a novel computerized battery for the diagnosis of ADHD in young adults. J Clin Exp Neuropsychol. 2007 Jan;29(1):100-11. doi: 10.1080/13803390500519738.
- Background: PubMed 25431555Micoulaud-Franchi JA, Geoffroy PA, Fond G, Lopez R, Bioulac S, Philip P. EEG neurofeedback treatments in children with ADHD: an updated meta-analysis of randomized controlled trials. Front Hum Neurosci. 2014 Nov 13;8:906. doi: 10.3389/fnhum.2014.00906. eCollection 2014.
- Background: PubMed 19715181Arns M, de Ridder S, Strehl U, Breteler M, Coenen A. Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta-analysis. Clin EEG Neurosci. 2009 Jul;40(3):180-9. doi: 10.1177/155005940904000311.
- Background: PubMed 30646779Riesco-Matias P, Yela-Bernabe JR, Crego A, Sanchez-Zaballos E. What Do Meta-Analyses Have to Say About the Efficacy of Neurofeedback Applied to Children With ADHD? Review of Previous Meta-Analyses and a New Meta-Analysis. J Atten Disord. 2021 Feb;25(4):473-485. doi: 10.1177/1087054718821731. Epub 2019 Jan 15.
- Individual participant dataSharing planned: No
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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.
Tamir Epstein, MD principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Neurofeedback and Treatment as Usual in people with Attention Deficit Hyperactivity Disorder, run by Sheba Medical Center.
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 3 inclusion and 9 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 2 Oct 2019. 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 Tamir Epstein, MD (+972-50-640-8442, tamir.epstein@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Continuous Performance Task (CPT) Response Time (time frame: baseline, immediately after 10-week intervention period). The study lists 3 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 NCT04112082, which also lists 6 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 2 Oct 2019.