DysphagiaNCT04040803

tACS and tRNS Studies on Brain Control of Swallowing

A study testing Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) in people with Dysphagia and Swallowing Disorder, run by University of Manchester at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dysphagia, Swallowing Disorder
What is being tested?: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited Kingdom
Study dates: 3 May 2019to 18 Mar 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history

Who cannot join

a history of epilepsy
cardiac pacemaker
previous brain surgery
previous swallowing problems
risk of potential pregnancy
metal in the head or eyes
use of medication that acts on the central nervous system.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Upper G.I laboratory, Salford Royal Hospital
Manchester, Greater Manchester, M6 8HD

Other trials in United Kingdom

About this study

Official title: Characterizing the Application of Transcranial Alternating Current Stimulation and Transcranial Random Noise Stimulation Over Human Pharyngeal Motor Cortex

Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) are two (CE marked medical devices) new, non-invasive (over the scalp) brain stimulation (NIBS) techniques. Both tACS and tRNS deliver a weak current continuously across the brain using pads placed over the scalp, which has been shown safe and well-tolerated by healthy adults and patients. These two techniques are able to softly alter physiological function within the brain. tACS can influence the brainwaves which have been demonstrated to play important roles in movement, sensation, and thinking functions. tACS and tRNS have been investigated for several years and have been shown to be safe, well tolerated and produce beneficial results in hand movement, hearing, and working memory.

Swallowing problems are life-threatening symptom among patients with brain impairments and elderly people. Until now, there are no studies investigating whether tACS and tRNS can have a beneficial effect on swallowing function in human. Our aim is to examine the effects of different strengths of tACS and tRNS to determine the best approach for brain stimulation that controls swallowing action, before using these techniques in patients with (neurological) swallowing disorders.

Participants: Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history will be recruited in the study.

Conditions: Dysphagia, Swallowing Disorder
Being tested: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)
Keywords: transcranial alternating current stimulation, transcranial random noise stimulation, frequency, full spectrum
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)Device
Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) are two (CE marked medical devices) new, non-invasive (over the scalp) brain stimulation (NIBS) techniques. Both tACS and tRNS deliver a weak current continuously across the brain using pads placed over the scalp, which has been shown safe and well-tolerated by healthy adults and patients. These two techniques are able to softly alter physiological function within the brain. tACS can influence the brainwaves which have been demonstrated to play important roles in movement, sensation, and thinking functions. tACS and tRNS have been investigated for several years and have been shown to be safe, well tolerated and produce beneficial results in hand movement, hearing, and working memory.

Study groups in NCT04040803
Study group	Role	What they receive
10 Hz tACS	Experimental	Stimulation will be applied at 10 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 10 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region. Receives: Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)
20 Hz tACS	Experimental	Stimulation will be applied at 20 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 20 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region. Receives: Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)
70Hz tACS	Experimental	Stimulation will be applied at 70 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 70 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region. Receives: Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)
0.1-640Hz tRNS	Experimental	Stimulation will be applied at 0.1-640Hz tRNS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 0.1-640Hz tRNS will be performed over the pharyngeal cortex region and contralateral supraorbital region. Receives: Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)
Sham	Sham comparator	Stimulation will be performed only for 10 s before the fade out, with 20 Hz tACS and an intensity of 1.5 mA (peak to peak). Sham condition will be applied over pseudo-stimulation of pharyngeal cortex region and contralateral supraorbital region. Receives: Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes of pharyngeal motor evoked potential amplitudes (PMEPs)
Cortical excitability of the pharyngeal motor cortices are being assessed as the primary endpoints. Therefore, the changes in EMG pharyngeal motor evoked potential amplitudes (PMEPs) following the intervention applied to pharyngeal motor cortex are being collected.
Measured: These cortical excitability measurements will be recorded at baseline, followed by immediately after intervention, then every 15 minutes up to 120 minutes afterwards.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 May 201918 Mar 2020

First posted1 Aug 2019
Study start3 May 2019
Primary completion15 Nov 2019
Study completion18 Mar 2020

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 DysphagiaStudies of the same condition, open and under way.
More trials run by University of ManchesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: All people studied will have each of the five treatments separately over different days in random order.
Masking: Single blind
Who is masked: Participant
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04040803
Sponsor's protocol ID: 2019-5932-10164
Status last verified: Mar 2020
First submitted: 25 Apr 2019
Last updated: 30 Mar 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The Gastrointestinal Sciences research team at the University of Manchester will have access to participants' identifiable information, but it will be anonymized as soon as participants are enrolled in this study. Representatives from the University of Manchester and regulatory authorities will have access to the anonymised data if required for auditing and monitoring process. However, participants' anonymised consent form, contact details, and data collected for this study will be retained for 5 years.

Publications

Antal A, Herrmann CS. Transcranial Alternating Current and Random Noise Stimulation: Possible Mechanisms. Neural Plast. 2016;2016:3616807. doi: 10.1155/2016/3616807. Epub 2016 May 3.
PubMed 27242932
Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
PubMed 28709880
Herrmann CS, Munk MH, Engel AK. Cognitive functions of gamma-band activity: memory match and utilization. Trends Cogn Sci. 2004 Aug;8(8):347-55. doi: 10.1016/j.tics.2004.06.006.
PubMed 15335461
Engel AK, Fries P, Singer W. Dynamic predictions: oscillations and synchrony in top-down processing. Nat Rev Neurosci. 2001 Oct;2(10):704-16. doi: 10.1038/35094565.
PubMed 11584308
Pollok B, Boysen AC, Krause V. The effect of transcranial alternating current stimulation (tACS) at alpha and beta frequency on motor learning. Behav Brain Res. 2015 Oct 15;293:234-40. doi: 10.1016/j.bbr.2015.07.049. Epub 2015 Jul 28.
PubMed 26225845
Wach C, Krause V, Moliadze V, Paulus W, Schnitzler A, Pollok B. Effects of 10 Hz and 20 Hz transcranial alternating current stimulation (tACS) on motor functions and motor cortical excitability. Behav Brain Res. 2013 Mar 15;241:1-6. doi: 10.1016/j.bbr.2012.11.038. Epub 2012 Dec 3.
PubMed 23219965
Jausovec N, Jausovec K. Increasing working memory capacity with theta transcranial alternating current stimulation (tACS). Biol Psychol. 2014 Feb;96:42-7. doi: 10.1016/j.biopsycho.2013.11.006. Epub 2013 Nov 27.
PubMed 24291565
Riecke L, Formisano E, Herrmann CS, Sack AT. 4-Hz Transcranial Alternating Current Stimulation Phase Modulates Hearing. Brain Stimul. 2015 Jul-Aug;8(4):777-83. doi: 10.1016/j.brs.2015.04.004. Epub 2015 Apr 24.
PubMed 25981160
Clave P, Shaker R. Dysphagia: current reality and scope of the problem. Nat Rev Gastroenterol Hepatol. 2015 May;12(5):259-70. doi: 10.1038/nrgastro.2015.49. Epub 2015 Apr 7.
PubMed 25850008
Jefferson S, Mistry S, Singh S, Rothwell J, Hamdy S. Characterizing the application of transcranial direct current stimulation in human pharyngeal motor cortex. Am J Physiol Gastrointest Liver Physiol. 2009 Dec;297(6):G1035-40. doi: 10.1152/ajpgi.00294.2009. Epub 2009 Oct 8.
PubMed 19815630
Moliadze V, Atalay D, Antal A, Paulus W. Close to threshold transcranial electrical stimulation preferentially activates inhibitory networks before switching to excitation with higher intensities. Brain Stimul. 2012 Oct;5(4):505-11. doi: 10.1016/j.brs.2011.11.004. Epub 2012 Feb 22.
PubMed 22445135
Uhlhaas PJ, Singer W. Abnormal neural oscillations and synchrony in schizophrenia. Nat Rev Neurosci. 2010 Feb;11(2):100-13. doi: 10.1038/nrn2774.
PubMed 20087360
Moisa M, Polania R, Grueschow M, Ruff CC. Brain Network Mechanisms Underlying Motor Enhancement by Transcranial Entrainment of Gamma Oscillations. J Neurosci. 2016 Nov 23;36(47):12053-12065. doi: 10.1523/JNEUROSCI.2044-16.2016.
PubMed 27881788
Fertonani A, Pirulli C, Miniussi C. Random noise stimulation improves neuroplasticity in perceptual learning. J Neurosci. 2011 Oct 26;31(43):15416-23. doi: 10.1523/JNEUROSCI.2002-11.2011.
PubMed 22031888
Rjosk V, Kaminski E, Hoff M, Gundlach C, Villringer A, Sehm B, Ragert P. Transcranial Alternating Current Stimulation at Beta Frequency: Lack of Immediate Effects on Excitation and Interhemispheric Inhibition of the Human Motor Cortex. Front Hum Neurosci. 2016 Nov 3;10:560. doi: 10.3389/fnhum.2016.00560. eCollection 2016.
PubMed 27857687

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterizing the Application of Transcranial Alternating Current Stimulation and Transcranial Random Noise Stimulation Over Human Pharyngeal Motor Cortex
ClinicalTrials.gov ID: NCT04040803
Acronym / sponsor ID: 2019-5932-10164
Conditions: Dysphagia, Swallowing Disorder
Keywords: transcranial alternating current stimulation, transcranial random noise stimulation, frequency, full spectrum
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of ManchesterUniversity, hospital or other
Study start: 3 May 2019 (actual)
Primary completion: 15 Nov 2019 (actual)
Study completion: 18 Mar 2020 (actual)
First posted: 1 Aug 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.

Participants: Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history will be recruited in the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 5
Model description: All people studied will have each of the five treatments separately over different days in random order.

Arm	Type	Receives
10 Hz tACS	Experimental	Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)Stimulation will be applied at 10 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 10 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.
20 Hz tACS	Experimental	Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)Stimulation will be applied at 20 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 20 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.
70Hz tACS	Experimental	Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)Stimulation will be applied at 70 Hz tACS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 70 Hz tACS will be performed over the pharyngeal cortex region and contralateral supraorbital region.
0.1-640Hz tRNS	Experimental	Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)Stimulation will be applied at 0.1-640Hz tRNS with an intensity of 1.5 mA (peak to peak), a fade in/out of 10 s and a duration of 10min. 0.1-640Hz tRNS will be performed over the pharyngeal cortex region and contralateral supraorbital region.
Sham	Sham comparator	Device: Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)Stimulation will be performed only for 10 s before the fade out, with 20 Hz tACS and an intensity of 1.5 mA (peak to peak). Sham condition will be applied over pseudo-stimulation of pharyngeal cortex region and contralateral supraorbital region.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy adults who are aged 18 years old or above with no medical complications or significant past medical history

Key exclusion criteria (7 listed)

a history of epilepsy
cardiac pacemaker
previous brain surgery
previous swallowing problems
risk of potential pregnancy

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
Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) are two (CE marked medical devices) new, non-invasive (over the scalp) brain stimulation (NIBS) techniques. Both tACS and tRNS deliver a weak current continuously across the brain using pads placed over the scalp, which has been shown safe and well-tolerated by healthy adults and patients. These two techniques are able to softly alter physiological function within the brain. tACS can influence the brainwaves which have been demonstrated to play important roles in movement, sensation, and thinking functions. tACS and tRNS have been investigated for several years and have been shown to be safe, well tolerated and produce beneficial results in hand movement, hearing, and working memory.	Device	0.1-640Hz tRNS, 10 Hz tACS, 20 Hz tACS, 70Hz tACS, Sham

Primary outcome

Changes of pharyngeal motor evoked potential amplitudes (PMEPs)
Time frame: These cortical excitability measurements will be recorded at baseline, followed by immediately after intervention, then every 15 minutes up to 120 minutes afterwards.
Cortical excitability of the pharyngeal motor cortices are being assessed as the primary endpoints. Therefore, the changes in EMG pharyngeal motor evoked potential amplitudes (PMEPs) following the intervention applied to pharyngeal motor cortex are being collected.

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 30 Mar 2020.
Background: PubMed 27242932Antal A, Herrmann CS. Transcranial Alternating Current and Random Noise Stimulation: Possible Mechanisms. Neural Plast. 2016;2016:3616807. doi: 10.1155/2016/3616807. Epub 2016 May 3.
Background: PubMed 28709880Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.
Background: PubMed 15335461Herrmann CS, Munk MH, Engel AK. Cognitive functions of gamma-band activity: memory match and utilization. Trends Cogn Sci. 2004 Aug;8(8):347-55. doi: 10.1016/j.tics.2004.06.006.
Background: PubMed 11584308Engel AK, Fries P, Singer W. Dynamic predictions: oscillations and synchrony in top-down processing. Nat Rev Neurosci. 2001 Oct;2(10):704-16. doi: 10.1038/35094565.
Background: PubMed 26225845Pollok B, Boysen AC, Krause V. The effect of transcranial alternating current stimulation (tACS) at alpha and beta frequency on motor learning. Behav Brain Res. 2015 Oct 15;293:234-40. doi: 10.1016/j.bbr.2015.07.049. Epub 2015 Jul 28.
Background: PubMed 23219965Wach C, Krause V, Moliadze V, Paulus W, Schnitzler A, Pollok B. Effects of 10 Hz and 20 Hz transcranial alternating current stimulation (tACS) on motor functions and motor cortical excitability. Behav Brain Res. 2013 Mar 15;241:1-6. doi: 10.1016/j.bbr.2012.11.038. Epub 2012 Dec 3.
Background: PubMed 24291565Jausovec N, Jausovec K. Increasing working memory capacity with theta transcranial alternating current stimulation (tACS). Biol Psychol. 2014 Feb;96:42-7. doi: 10.1016/j.biopsycho.2013.11.006. Epub 2013 Nov 27.
Background: PubMed 25981160Riecke L, Formisano E, Herrmann CS, Sack AT. 4-Hz Transcranial Alternating Current Stimulation Phase Modulates Hearing. Brain Stimul. 2015 Jul-Aug;8(4):777-83. doi: 10.1016/j.brs.2015.04.004. Epub 2015 Apr 24.
Background: PubMed 25850008Clave P, Shaker R. Dysphagia: current reality and scope of the problem. Nat Rev Gastroenterol Hepatol. 2015 May;12(5):259-70. doi: 10.1038/nrgastro.2015.49. Epub 2015 Apr 7.
Results publication: PubMed 19815630Jefferson S, Mistry S, Singh S, Rothwell J, Hamdy S. Characterizing the application of transcranial direct current stimulation in human pharyngeal motor cortex. Am J Physiol Gastrointest Liver Physiol. 2009 Dec;297(6):G1035-40. doi: 10.1152/ajpgi.00294.2009. Epub 2009 Oct 8.
Results publication: PubMed 22445135Moliadze V, Atalay D, Antal A, Paulus W. Close to threshold transcranial electrical stimulation preferentially activates inhibitory networks before switching to excitation with higher intensities. Brain Stimul. 2012 Oct;5(4):505-11. doi: 10.1016/j.brs.2011.11.004. Epub 2012 Feb 22.
Results publication: PubMed 20087360Uhlhaas PJ, Singer W. Abnormal neural oscillations and synchrony in schizophrenia. Nat Rev Neurosci. 2010 Feb;11(2):100-13. doi: 10.1038/nrn2774.
Individual participant dataSharing planned: No. The Gastrointestinal Sciences research team at the University of Manchester will have access to participants' identifiable information, but it will be anonymized as soon as participants are enrolled in this study. Representatives from the University of Manchester and regulatory authorities will have access to the anonymised data if required for auditing and monitoring process. However, participants' anonymised consent form, contact details, and data collected for this study will be retained for 5 years.

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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.

Shaheen Hamdy, MD,PhD principal investigator

GI-sciences, Salford Royal NHS Foundation Trust, University of Manchester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 7 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 30 Mar 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 Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of pharyngeal motor evoked potential amplitudes (PMEPs) (time frame: These cortical excitability measurements will be recorded at baseline, followed by immediately after intervention, then every 15 minutes up to 120 minutes afterwards.). 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 NCT04040803, 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 30 Mar 2020.