Pain PerceptionNCT03744897
Effect of Hypnosis Combined to Transcranial Direct Stimulation in Pain
A study testing Hypnotic analgesia, a-tDCS and Hypnotic analgesia + a-tDCS in people with Pain Perception and Pain Acute, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial summary
Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Perception, Pain Acute
- What is being tested?
- Hypnotic analgesia, a-tDCS and Hypnotic analgesia + a-tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesBrazil
- Study dates
- 18 Jul 2017to 1 Nov 2018
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Female
- 11 years of schooling
- 12 cut-off at Waterloo-Stanford Group C (WSGC)
Who cannot join
- hearing loss subjects
- formal contraindication to tDCS (pregnancy, deep brain device, epilepsy, seizure)
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.450-120
Hospital de Clinicas e Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, 90035-003
About this study
Official title: Effect of Hypnosis Combined to Transcranial Direct Stimulation in Cortical Activity and Pain Perception in Healthy Females
Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS).
Read the detailed description
Introduction: Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS). Objective: To evaluate the synergistic effect of hypnotic analgesia associated with tDCS under metabolites parameters and pain levels in healthy individuals before a nociceptive stimulation pattern. Methods: it will be performed a blinded crossover sham controlled randomized clinical trial. It will be included 32 woman healthy subjects, Susceptible to the hypnosis technique according to the Scale of Hypnotic Susceptibility (WSGC) Scale of Hypnotic Scale score. aged 18 to 65. They will be allocated in one of the following groups: active tDCS + hypnotic analgesia, sham tDCS + hypnotic analgesia, hypnotic analgesia and tDCS . After a 7 days interval, the groups will be crossed in order to receive the opposite intervention of the first week. The primary endpoints will be the electrophysiological brain parameters, such as changes in the Theta, Alpha and Gamma waves, as measured by EEG. The secondary endpoints will be the level of pain, measured against nociceptive induced by the cold test and stimuli standardized pressure through algometry pressure and power down system modulatory pain, pain using the subject test - CPM - task. The intra and inter-group comparisons will be made by means of two-way ANOVA followed by Bonferroni. A p significance level of <0.05 was established. Expected results: This study hypothesizes that a synergistic effect of analgesic techniques in pain levels in healthy subjects compared to isolated character.
- Conditions
- Pain Perception, Pain Acute
- Being tested
- Hypnotic analgesia, a-tDCS, Hypnotic analgesia + a-tDCS, s-tDCS
- Keywords
- pain perception, tDCS, Hypnosis, cortical activity
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic analgesiaBehavioural
Subjects will receive hypnotic analgesia during 20 minutes
a-tDCSDevice
Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
Hypnotic analgesia + a-tDCSOther
Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
s-tDCSDevice
Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Hypnotic analgesia | Experimental | Intervention:
- Subjects will receive hypnotic analgesia Receives: Behavioral: Hypnotic analgesia |
| a-tDCS | Experimental | Intervention: transcranial direct current stimulation - tDCS
* active tDCS stimulation
* montage: bilateral DLPFC anodal/left and cathodal/right
* current:2 milliamps
* time: 20 minutes Receives: Behavioral: Hypnotic analgesia; Device: s-tDCS |
| s-tDCS | Sham comparator | Sham comparator: transcranial direct current stimulation - tDCS
* sham tDCS stimulation
* montage: bilateral DLPFC anodal/left and cathodal/right
* current: 0 milliamps
* time: 20 minutes Receives: Device: a-tDCS; Other: Hypnotic analgesia + a-tDCS |
| Hypnotic analgesia + a-tDCS | Experimental | Intervention:
* hypnotic analgesia
* active tDCS stimulation
* montage: bilateral DLPFC anodal/left and cathodal/right
* current:2 milliamps
* time: 20 minutes Receives: Other: Hypnotic analgesia + a-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alpha waves
Variations in the alpha waves power from post to pre-intervention using electroencephalography during a cold pressor test
Measured: 60 minutes
Change in Theta waves
Variations in the theta waves power from post to pre-intervention using electroencephalography during a cold pressor test
Measured: 60 minutes
Secondary outcomes (10)
Change in beta waves
Variations in the beta waves power from post to pre-intervention using electroencephalography during a cold pressor test
Measured: 60 minutes
Change in gamma waves
Variations in the gamma waves power from post to pre-intervention using electroencephalography during a cold pressor test
Measured: 60 minutes
Change in delta waves
Variations in the delta waves power from post to pre-intervention using electroencephalography during a cold pressor test
Measured: 60 minutes
Change in Heat thermal threshold
The measure will be assessed by Quantitative Sensorial Test - QST, in which a thermode delivers a heat stimulus of increasing magnitude. Heat thermal threshold (HTT) is the averaged temperature for 3 stimuli where participant indicates the first heat sensation.
Measured: 60 minutes
Change in Heat pain threshold
The measure will be assessed by Quantitative Sensorial Test - QST, in which a thermode delivers a heat stimulus of increasing magnitude. Heat pain threshold (HPT) is the averaged temperature for 3 stimuli where participant indicates the first heat pain sensation.
Measured: 60 minutes
Change in Heat pain tolerance
The measure will be assessed by Quantitative Sensorial Test - QST, in which a thermode delivers a heat stimulus of increasing magnitude. Heat pain tolerance (HPTo) is the temperature for the stimulus where participant indicates the maximum pain tolerance.
Measured: 60 minutes
Change in Numeric pain scale during CPM task
The measure will be assessed by the conditioned pain modulation (CPM) task in which an ice cold water (0 a 1 degrees Celsius) is the conditioning stimulus presented to the left hand and a moderate heat pain stimulus from the QST to the contralateral hand. The measure consists of the response using a numeric pain scale (0 - 10) for the heat pain stimulus during the CPM task.
Measured: 60 minutes
Change in Cold Pressor Test 0 to 1 degree Celsius - time
Participant puts his right hand in an ice cold water (0 a 1 degrees Celsius). Measure consists of the time (in seconds) the participant keeps his hand in the water the maximum he could tolerance.
Measured: 60 minutes
Change in Cold Pressor Test 10 degree Celsius - time
Participant puts his right hand in an ice cold water (10 degrees Celsius). Measure consists of the time (in seconds) the participant keeps his hand in the water the maximum he could tolerate.
Measured: 60 minutes
Change in Cold Pressor Test 10 degree Celsius - pain
Participant puts his right hand in an ice cold water (10 degrees Celsius). Measure consists of the response to a numeric pain scale (0 to 10) to the pain sensation when the participant withdraw his hand from the water.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start18 Jul 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain PerceptionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1. Hypnotic analgesia + a-tDCS 2. Hypnotic analgesia + s-tDCS 3. Hypnotic analgesia 4. a-tDCS
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolnei Caumo, Hospital de Clinicas de Porto Alegre
- Investigators
- Wolnei Caumo, MD. PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744897
- Sponsor's protocol ID
- 16-0635
- Status last verified
- Nov 2018
- First submitted
- 21 Sep 2017
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen MP, Sherlin LH, Fregni F, Gianas A, Howe JD, Hakimian S. Baseline brain activity predicts response to neuromodulatory pain treatment. Pain Med. 2014 Dec;15(12):2055-63. doi: 10.1111/pme.12546. Epub 2014 Oct 7.
PubMed 25287554Jensen MP, Day MA, Miro J. Neuromodulatory treatments for chronic pain: efficacy and mechanisms. Nat Rev Neurol. 2014 Mar;10(3):167-78. doi: 10.1038/nrneurol.2014.12. Epub 2014 Feb 18.
PubMed 24535464Vanegas H, Schaible HG. Descending control of persistent pain: inhibitory or facilitatory? Brain Res Brain Res Rev. 2004 Nov;46(3):295-309. doi: 10.1016/j.brainresrev.2004.07.004.
PubMed 15571771Foerster AS, Rezaee Z, Paulus W, Nitsche MA, Dutta A. Effects of Cathode Location and the Size of Anode on Anodal Transcranial Direct Current Stimulation Over the Leg Motor Area in Healthy Humans. Front Neurosci. 2018 Jul 4;12:443. doi: 10.3389/fnins.2018.00443. eCollection 2018.
PubMed 30022928Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJ, Lima MC, Rigonatti SP, Marcolin MA, Freedman SD, Nitsche MA, Pascual-Leone A. Transcranial direct current stimulation of the unaffected hemisphere in stroke patients. Neuroreport. 2005 Sep 28;16(14):1551-5. doi: 10.1097/01.wnr.0000177010.44602.5e.
PubMed 16148743Beltran Serrano G, Pooch Rodrigues L, Schein B, Zortea M, Torres ILS, Fregni F, Caumo W. The Hypnotic Analgesia Suggestion Mitigated the Effect of the Transcranial Direct Current Stimulation on the Descending Pain Modulatory System: A Proof of Concept Study. J Pain Res. 2020 Sep 16;13:2297-2311. doi: 10.2147/JPR.S253747. eCollection 2020.
PubMed 32982393Beltran Serrano G, Rodrigues LP, Schein B, Souza A, Torres ILS, da Conceicao Antunes L, Fregni F, Caumo W. Comparison of Hypnotic Suggestion and Transcranial Direct-Current Stimulation Effects on Pain Perception and the Descending Pain Modulating System: A Crossover Randomized Clinical Trial. Front Neurosci. 2019 Jun 26;13:662. doi: 10.3389/fnins.2019.00662. eCollection 2019.
PubMed 31297046
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypnosis Combined to Transcranial Direct Stimulation in Cortical Activity and Pain Perception in Healthy Females
- ClinicalTrials.gov ID
- NCT03744897
- Acronym / sponsor ID
- 16-0635
- Conditions
- Pain Perception, Pain Acute
- Keywords
- pain perception, tDCS, Hypnosis, cortical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 19 Nov 2018 (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.
Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS).
Detailed description
Introduction: Pain is a public health condition, which causes great functional disability. Its consequences pervade the personal and social life of the patient, leading to significant changes in their interpersonal relationships, including work, family and social spheres, reducing the ability to perform daily activities. Conventional treatment modalities have been show a very poor therapeutic response, in that most individuals end up becoming polymedicated patients and refractory to treatment. Among non-pharmacological techniques with promising analgesic effects it includes both the hypnotic analgesia and the transcranial stimulation of direct current (tDCS). Objective: To evaluate the synergistic effect of hypnotic analgesia associated with tDCS under metabolites parameters and pain levels in healthy individuals before a nociceptive stimulation pattern. Methods: it will be performed a blinded crossover sham controlled randomized clinical trial. It will be included 32 woman healthy subjects, Susceptible to the hypnosis technique according to the Scale of Hypnotic Susceptibility (WSGC) Scale of Hypnotic Scale score. aged 18 to 65. They will be allocated in one of the following groups: active tDCS + hypnotic analgesia, sham tDCS + hypnotic analgesia, hypnotic analgesia and tDCS . After a 7 days interval, the groups will be crossed in order to receive the opposite intervention of the first week. The primary endpoints will be the electrophysiological brain parameters, such as changes in the Theta, Alpha and Gamma waves, as measured by EEG. The secondary endpoints will be the level of pain, measured against nociceptive induced by the cold test and stimuli standardized pressure through algometry pressure and power down system modulatory pain, pain using the subject test - CPM - task. The intra and inter-group comparisons will be made by means of two-way ANOVA followed by Bonferroni. A p significance level of <0.05 was established. Expected results: This study hypothesizes that a synergistic effect of analgesic techniques in pain levels in healthy subjects compared to isolated character.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 1. Hypnotic analgesia + a-tDCS 2. Hypnotic analgesia + s-tDCS 3. Hypnotic analgesia 4. a-tDCS
| Arm | Type | Receives |
|---|---|---|
| Hypnotic analgesia | Experimental | Behavioral: Hypnotic analgesiaIntervention: - Subjects will receive hypnotic analgesia |
| a-tDCS | Experimental | Behavioral: Hypnotic analgesia, Device: s-tDCSIntervention: transcranial direct current stimulation - tDCS * active tDCS stimulation * montage: bilateral DLPFC anodal/left and cathodal/right * current:2 milliamps * time: 20 minutes |
| s-tDCS | Sham comparator | Device: a-tDCS, Other: Hypnotic analgesia + a-tDCSSham comparator: transcranial direct current stimulation - tDCS * sham tDCS stimulation * montage: bilateral DLPFC anodal/left and cathodal/right * current: 0 milliamps * time: 20 minutes |
| Hypnotic analgesia + a-tDCS | Experimental | Other: Hypnotic analgesia + a-tDCSIntervention: * hypnotic analgesia * active tDCS stimulation * montage: bilateral DLPFC anodal/left and cathodal/right * current:2 milliamps * time: 20 minutes |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Female
- 11 years of schooling
- 12 cut-off at Waterloo-Stanford Group C (WSGC)
Key exclusion criteria (2 listed)
- hearing loss subjects
- formal contraindication to tDCS (pregnancy, deep brain device, epilepsy, seizure)
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 |
|---|---|---|
| Hypnotic analgesiaSubjects will receive hypnotic analgesia during 20 minutes | Behavioural | Hypnotic analgesia, a-tDCS |
| a-tDCSSubjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes | Device | s-tDCS |
| Hypnotic analgesia + a-tDCSSubjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes | Other | Hypnotic analgesia + a-tDCS, s-tDCS |
| s-tDCSSubjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes | Device | a-tDCS |
Primary outcome
Change in Alpha waves
Time frame: 60 minutes
Variations in the alpha waves power from post to pre-intervention using electroencephalography during a cold pressor test
Change in Theta waves
Time frame: 60 minutes
Variations in the theta waves power from post to pre-intervention using electroencephalography during a cold pressor test
10 secondary outcomes
Change in beta waves
Time frame: 60 minutes
Change in gamma waves
Time frame: 60 minutes
Change in delta waves
Time frame: 60 minutes
Change in Heat thermal threshold
Time frame: 60 minutes
Change in Heat pain threshold
Time frame: 60 minutes
Change in Heat pain tolerance
Time frame: 60 minutes
Change in Numeric pain scale during CPM task
Time frame: 60 minutes
Change in Cold Pressor Test 0 to 1 degree Celsius - time
Time frame: 60 minutes
Change in Cold Pressor Test 10 degree Celsius - time
Time frame: 60 minutes
Change in Cold Pressor Test 10 degree Celsius - pain
Time frame: 60 minutes
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 26 Nov 2018.
- Results publication: PubMed 25287554Jensen MP, Sherlin LH, Fregni F, Gianas A, Howe JD, Hakimian S. Baseline brain activity predicts response to neuromodulatory pain treatment. Pain Med. 2014 Dec;15(12):2055-63. doi: 10.1111/pme.12546. Epub 2014 Oct 7.
- Results publication: PubMed 24535464Jensen MP, Day MA, Miro J. Neuromodulatory treatments for chronic pain: efficacy and mechanisms. Nat Rev Neurol. 2014 Mar;10(3):167-78. doi: 10.1038/nrneurol.2014.12. Epub 2014 Feb 18.
- Results publication: PubMed 15571771Vanegas H, Schaible HG. Descending control of persistent pain: inhibitory or facilitatory? Brain Res Brain Res Rev. 2004 Nov;46(3):295-309. doi: 10.1016/j.brainresrev.2004.07.004.
- Results publication: PubMed 30022928Foerster AS, Rezaee Z, Paulus W, Nitsche MA, Dutta A. Effects of Cathode Location and the Size of Anode on Anodal Transcranial Direct Current Stimulation Over the Leg Motor Area in Healthy Humans. Front Neurosci. 2018 Jul 4;12:443. doi: 10.3389/fnins.2018.00443. eCollection 2018.
- Results publication: PubMed 16148743Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJ, Lima MC, Rigonatti SP, Marcolin MA, Freedman SD, Nitsche MA, Pascual-Leone A. Transcranial direct current stimulation of the unaffected hemisphere in stroke patients. Neuroreport. 2005 Sep 28;16(14):1551-5. doi: 10.1097/01.wnr.0000177010.44602.5e.
- Derived from this study: PubMed 32982393Beltran Serrano G, Pooch Rodrigues L, Schein B, Zortea M, Torres ILS, Fregni F, Caumo W. The Hypnotic Analgesia Suggestion Mitigated the Effect of the Transcranial Direct Current Stimulation on the Descending Pain Modulatory System: A Proof of Concept Study. J Pain Res. 2020 Sep 16;13:2297-2311. doi: 10.2147/JPR.S253747. eCollection 2020.
- Derived from this study: PubMed 31297046Beltran Serrano G, Rodrigues LP, Schein B, Souza A, Torres ILS, da Conceicao Antunes L, Fregni F, Caumo W. Comparison of Hypnotic Suggestion and Transcranial Direct-Current Stimulation Effects on Pain Perception and the Descending Pain Modulating System: A Crossover Randomized Clinical Trial. Front Neurosci. 2019 Jun 26;13:662. doi: 10.3389/fnins.2019.00662. eCollection 2019.
- 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.
Wolnei Caumo, MD. PhD principal investigator
Federal University of Rio Grande do Sul
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic analgesia, a-tDCS and Hypnotic analgesia + a-tDCS in people with Pain Perception and Pain Acute, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
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 2 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 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Change in Alpha waves (time frame: 60 minutes). The study lists 2 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 NCT03744897, which also lists 7 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 26 Nov 2018.