Cerebral Palsy (CP)ImmersiveAOTNCT07369193
Immersive AOT: Multisensory Stimulation and Neurophysiological Correlates in Children With Cerebral Palsy and Typical Development - A Pilot Study
An observational study of Cerebral Palsy (CP) and CP (Cerebral Palsy), run by IRCCS Fondazione Stella Maris at 1 site in Italy.
Trial summary
The discovery of the Mirror Neuron System (MNS) has promoted the development of rehabilitation techniques such as Action Observation Treatment (AOT) and Motor Imagery (MI). These are based on the principle that neural circuits active during execution, also activate during the observation or imagination of movements. Read more about this study
- Who is it for?
- Ages 7 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy (CP), CP (Cerebral Palsy), Motor Imagery
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jan 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: For this study, 20 children, adolescents, and young adults with typical development will be recruited (community sample), toghether with 20 children and adolescents diagnosed with CP (recruit at the IRCCS Fondazione Stella Maris).
Who may be able to join
None listed.
Who cannot join
- Severe sensory disorders that compromise the feasibility of the study;
- Neuropsychiatric comorbidity that precludes participation in the study.
- Control group: Inclusion Criteria
- Age between 7 and 25 years at the time of recruitment;
- Absence of intellectual disability, assessed through age-appropriate versions of the Raven's Progressive Matrices (Coloured Progressive Matrices for children up to 11 years; Standard Progressive Matrices for participants aged 12 years and older), yielding scores within the normative range and used to estimate non-verbal fluid intelligence;
- Age-appropriate academic performance with no reports of significant learning difficulties, as verified through parental interview;
- Absence of known neurological or psychiatric disorders, confirmed through parental interview;
- Absence of motor impairments, defined as scoring above the 25th percentile on the Movement Assessment Battery for Children, Second Edition (MABC-2).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Stella Maris
Calambrone, Pisa, 56128
Giuseppina Sgandurra, PhD, MD, 050/886233, gsgandurra@fsm.unipi.it
About this study
Official title: Immersive AOT: Multisensory Stimulation and Neurophysiological Correlates - A Pilot Study
The discovery of the Mirror Neuron System (MNS) has promoted the development of rehabilitation techniques such as Action Observation Treatment (AOT) and Motor Imagery (MI). These are based on the principle that neural circuits active during execution, also activate during the observation or imagination of movements. These techniques have been found to be effective in several clinical populations including children with Cerebral Palsy (CP), the most common childhood-onset motor disorder. We hypothesize that a multimodal version of AOT, integrating not only visual stimuli (standard practice) but also auditory and tactile stimuli, could further enhance the activation of the MNS. In fact, everyday actions naturally involve multiple sensory channels, and evidence indicate that audio-visual action observation activates the MNS more intensely than visual stimuli alone, thus offering a potential improvement for CP rehabilitation.
The primary aim of this observational pilot study, conducted at IRCCS Fondazione Stella Maris, is to verify whether a multisensory (=immersive) AO session - combining visual, auditory, and tactile stimuli - produces greater activation of the MNS, than a traditional session (visual AO alone). Neural correlates will be measured through high-density Electroencephalography (hdEEG), with a specific focus on the modulation of the sensorimotor mu rhythm. Twenty children and adolescents with CP, aged 7-25 years, and 20 typically developing (TD) aged-matched peers will be recruited in the study. The study also aims to assess the level of participants' attention during stimuli presentation through eye tracking, and to verify whether immersive AO can influence MI abilities, measured through specific tasks and questionnaires (i.e., Motor Imagery Questionnaire for Children (MIQ-C, aged 7-12) and the Motor Imagery Questionnaire - 3 (MIQ-3) for adolescent). In an initial phase of the study both questionnaires will be the validated in a separate sample of 120 TD Italian children and 120 Italian adolescents or adults. The absence of intellectual disability will be assessed using the age-appropriate version of Raven's Progressive Matrices test.
Read more
Each participant will undergo two EEG sessions: the immersive session will consist of watching first-person videos accompanied by auditory stimuli consistent with the action and tactile stimuli provided by TouchDIVER Pro haptic gloves (Weart, CE-marked device), suitably adapted for the paediatric population. The traditional session will consist of watching videos without sounds or any tactile additional stimulus. The two sessions will be performed in a in random order. In both sessions, after the observation phase, participants will be asked to perform or imagine the same actions presented in the videos. During observation, eye movements and gaze behavior will be monitored using an eye tracking system. Throughout each session, cortical activity will be recorded using a 128-channel hdEEG net. The sessions will be video-recorded to accurately monitor participants motor behavior, response times, and compliance with the protocol.
At the end of each EEG session, participants will be administered the MIQ-C or MIQ-3 questionnaire and a short task to assess MI abilities. In this task, participants will watch some of the videos previously used during the EEG session and will then be asked to imagine the same action. In this case, their imagery will be interrupted at specific time points, and they will be asked to select, from two images, the moment of the action corresponding to the point at which they were interrupted.
Data analysis will examine within- and between-groups differences for the immersive AO vs the traditional AO. Correlation analysis will be also performed between neurophysiological data, attentional data, questionnaires, MI responses and standardized clinical assessments ( for the CP group), in order to understand how the participants' motor and cognitive abilities influence the activation of the circuits involved in the experimental tasks.
- Keywords
- Immersive, AOT, Cerebral Palsy, Motor Imagery, haptic gloves, eye-tracker, Mirror Neuron System, EEG, multisensory
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Study Group) | 20 participants aged 7-25 years diagnosed with Cerebral Palsy (CP) | |
| Group 2 (Control Group) | 20 participants with typical development (TD) aged 7-25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiological data (hdEEG)
The primary outcome will be represented by the neurophysiological data obtained from the two recording sessions. Spectral and time-frequency analyses will be performed to examine the reactivity of specific frequency bands (e.g., sensorimotor mu rhythm and attentional alpha rhythm) in relation the presented stimuli. Event-related desynchronization/synchronization (ERD/ERS) patterns will be compared across sessions and between groups.
Measured: one hour per session
Secondary outcomes (1)
Attention and motor imagery data
Secondary outcomes will be represented by data on participants' attention (eye tracker) and MI. Analysis of data obtained from the eye tracking will focus on eye movements, stimulus fixation duration, and saccadic movements during video viewing. Scores from the MIQ-C and MIQ-3 questionnaires and the MI task results will also be included. These data will compared across sessions and between groups. Also, aorrelation analyses with EEG data will be performed.
Measured: One hour per session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start19 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Siena
- Responsible party
- Principal investigator, Giuseppina Sgandurra, IRCCS Fondazione Stella Maris
- Investigators
- Giuseppina Sgandurra, PhD, MD, Principal investigator, IRCCS Fondazione Stella Maris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369193
- Sponsor's protocol ID
- ImmersiveAOT
- Acronym
- ImmersiveAOT
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rizzolatti G, Fadiga L, Gallese V, Fogassi L. Premotor cortex and the recognition of motor actions. Brain Res Cogn Brain Res. 1996 Mar;3(2):131-41. doi: 10.1016/0926-6410(95)00038-0.
PubMed 8713554Pineda JA. The functional significance of mu rhythms: translating "seeing" and "hearing" into "doing". Brain Res Brain Res Rev. 2005 Dec 1;50(1):57-68. doi: 10.1016/j.brainresrev.2005.04.005. Epub 2005 May 31.
PubMed 15925412Paulus M, Hunnius S, Bekkering H. Neurocognitive mechanisms underlying social learning in infancy: infants' neural processing of the effects of others' actions. Soc Cogn Affect Neurosci. 2013 Oct;8(7):774-9. doi: 10.1093/scan/nss065. Epub 2012 Jun 11.
PubMed 22689219Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
PubMed 32086598Marshall PJ, Meltzoff AN. Neural mirroring systems: exploring the EEG mu rhythm in human infancy. Dev Cogn Neurosci. 2011 Apr;1(2):110-23. doi: 10.1016/j.dcn.2010.09.001.
PubMed 21528008Kohler E, Keysers C, Umilta MA, Fogassi L, Gallese V, Rizzolatti G. Hearing sounds, understanding actions: action representation in mirror neurons. Science. 2002 Aug 2;297(5582):846-8. doi: 10.1126/science.1070311.
PubMed 12161656Keysers C, Kohler E, Umilta MA, Nanetti L, Fogassi L, Gallese V. Audiovisual mirror neurons and action recognition. Exp Brain Res. 2003 Dec;153(4):628-36. doi: 10.1007/s00221-003-1603-5. Epub 2003 Aug 23.
PubMed 12937876Keysers C, Kaas JH, Gazzola V. Somatosensation in social perception. Nat Rev Neurosci. 2010 Jun;11(6):417-28. doi: 10.1038/nrn2833. Epub 2010 May 6.
PubMed 20445542Kaplan JT, Iacoboni M. Multimodal action representation in human left ventral premotor cortex. Cogn Process. 2007 Jun;8(2):103-13. doi: 10.1007/s10339-007-0165-z. Epub 2007 May 15.
PubMed 17503101Hetu S, Gregoire M, Saimpont A, Coll MP, Eugene F, Michon PE, Jackson PL. The neural network of motor imagery: an ALE meta-analysis. Neurosci Biobehav Rev. 2013 Jun;37(5):930-49. doi: 10.1016/j.neubiorev.2013.03.017. Epub 2013 Apr 10.
PubMed 23583615Fox NA, Bakermans-Kranenburg MJ, Yoo KH, Bowman LC, Cannon EN, Vanderwert RE, Ferrari PF, van IJzendoorn MH. Assessing human mirror activity with EEG mu rhythm: A meta-analysis. Psychol Bull. 2016 Mar;142(3):291-313. doi: 10.1037/bul0000031. Epub 2015 Dec 21.
PubMed 26689088Demas J, Bourguignon M, Perivier M, De Tiege X, Dinomais M, Van Bogaert P. Mu rhythm: State of the art with special focus on cerebral palsy. Ann Phys Rehabil Med. 2020 Oct;63(5):439-446. doi: 10.1016/j.rehab.2019.06.007. Epub 2019 Jul 9.
PubMed 31299375Bakker M, Sommerville JA, Gredeback G. Enhanced Neural Processing of Goal-directed Actions After Active Training in 4-Month-Old Infants. J Cogn Neurosci. 2016 Mar;28(3):472-82. doi: 10.1162/jocn_a_00909. Epub 2015 Dec 17.
PubMed 26679217
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive AOT: Multisensory Stimulation and Neurophysiological Correlates - A Pilot Study
- ClinicalTrials.gov ID
- NCT07369193
- Acronym / sponsor ID
- ImmersiveAOT / ImmersiveAOT
- Keywords
- Immersive, AOT, Cerebral Palsy, Motor Imagery, haptic gloves, eye-tracker, Mirror Neuron System, EEG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- University of Siena
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Jan 2026 (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 discovery of the Mirror Neuron System (MNS) has promoted the development of rehabilitation techniques such as Action Observation Treatment (AOT) and Motor Imagery (MI). These are based on the principle that neural circuits active during execution, also activate during the observation or imagination of movements. These techniques have been found to be effective in several clinical populations including children with Cerebral Palsy (CP), the most common childhood-onset motor disorder. We hypothesize that a multimodal version of AOT, integrating not only visual stimuli (standard practice) but also auditory and tactile stimuli, could further enhance the activation of the MNS. In fact, everyday actions naturally involve multiple sensory channels, and evidence indicate that audio-visual action observation activates the MNS more intensely than visual stimuli alone, thus offering a potential improvement for CP rehabilitation.
The primary aim of this observational pilot study, conducted at IRCCS Fondazione Stella Maris, is to verify whether a multisensory (=immersive) AO session - combining visual, auditory, and tactile stimuli - produces greater activation of the MNS, than a traditional session (visual AO alone). Neural correlates will be measured through high-density Electroencephalography (hdEEG), with a specific focus on the modulation of the sensorimotor mu rhythm. Twenty children and adolescents with CP, aged 7-25 years, and 20 typically developing (TD) aged-matched peers will be recruited in the study. The study also aims to assess the level of participants' attention during stimuli presentation through eye tracking, and to verify whether immersive AO can influence MI abilities, measured through specific tasks and questionnaires (i.e., Motor Imagery Questionnaire for Children (MIQ-C, aged 7-12) and the Motor Imagery Questionnaire - 3 (MIQ-3) for adolescent). In an initial phase of the study both questionnaires will be the validated in a separate sample of 120 TD Italian children and 120 Italian adolescents or adults. The absence of intellectual disability will be assessed using the age-appropriate version of Raven's Progressive Matrices test.
Each participant will undergo two EEG sessions: the immersive session will consist of watching first-person videos accompanied by auditory stimuli consistent with the action and tactile stimuli provided by TouchDIVER Pro haptic gloves (Weart, CE-marked device), suitably adapted for the paediatric population. The traditional session will consist of watching videos without sounds or any tactile additional stimulus. The two sessions will be performed in a in random order. In both sessions, after the observation phase, participants will be asked to perform or imagine the same actions presented in the videos. During observation, eye movements and gaze behavior will be monitored using an eye tracking system. Throughout each session, cortical activity will be recorded using a 128-channel hdEEG net. The sessions will be video-recorded to accurately monitor participants motor behavior, response times, and compliance with the protocol.
At the end of each EEG session, participants will be administered the MIQ-C or MIQ-3 questionnaire and a short task to assess MI abilities. In this task, participants will watch some of the videos previously used during the EEG session and will then be asked to imagine the same action. In this case, their imagery will be interrupted at specific time points, and they will be asked to select, from two images, the moment of the action corresponding to the point at which they were interrupted.
Data analysis will examine within- and between-groups differences for the immersive AO vs the traditional AO. Correlation analysis will be also performed between neurophysiological data, attentional data, questionnaires, MI responses and standardized clinical assessments ( for the CP group), in order to understand how the participants' motor and cognitive abilities influence the activation of the circuits involved in the experimental tasks.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Study Group) | – | –20 participants aged 7-25 years diagnosed with Cerebral Palsy (CP) |
| Group 2 (Control Group) | – | –20 participants with typical development (TD) aged 7-25 |
Who may qualify
- Ages
- 7 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- For this study, 20 children, adolescents, and young adults with typical development will be recruited (community sample), toghether with 20 children and adolescents diagnosed with CP (recruit at the IRCCS Fondazione Stella Maris).
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Severe sensory disorders that compromise the feasibility of the study;
- Neuropsychiatric comorbidity that precludes participation in the study.
- Control group: Inclusion Criteria
- Age between 7 and 25 years at the time of recruitment;
- Absence of intellectual disability, assessed through age-appropriate versions of the Raven's Progressive Matrices (Coloured Progressive Matrices for children up to 11 years; Standard Progressive Matrices for participants aged 12 years and older), yielding scores within the normative range and used to estimate non-verbal fluid intelligence;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurophysiological data (hdEEG)
Time frame: one hour per session
The primary outcome will be represented by the neurophysiological data obtained from the two recording sessions. Spectral and time-frequency analyses will be performed to examine the reactivity of specific frequency bands (e.g., sensorimotor mu rhythm and attentional alpha rhythm) in relation the presented stimuli. Event-related desynchronization/synchronization (ERD/ERS) patterns will be compared across sessions and between groups.
1 secondary outcome
Attention and motor imagery data
Time frame: One hour per session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 8713554Rizzolatti G, Fadiga L, Gallese V, Fogassi L. Premotor cortex and the recognition of motor actions. Brain Res Cogn Brain Res. 1996 Mar;3(2):131-41. doi: 10.1016/0926-6410(95)00038-0.
- Results publication: PubMed 15925412Pineda JA. The functional significance of mu rhythms: translating "seeing" and "hearing" into "doing". Brain Res Brain Res Rev. 2005 Dec 1;50(1):57-68. doi: 10.1016/j.brainresrev.2005.04.005. Epub 2005 May 31.
- Results publication: PubMed 22689219Paulus M, Hunnius S, Bekkering H. Neurocognitive mechanisms underlying social learning in infancy: infants' neural processing of the effects of others' actions. Soc Cogn Affect Neurosci. 2013 Oct;8(7):774-9. doi: 10.1093/scan/nss065. Epub 2012 Jun 11.
- Results publication: PubMed 32086598Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.
- Results publication: PubMed 21528008Marshall PJ, Meltzoff AN. Neural mirroring systems: exploring the EEG mu rhythm in human infancy. Dev Cogn Neurosci. 2011 Apr;1(2):110-23. doi: 10.1016/j.dcn.2010.09.001.
- Results publication: PubMed 12161656Kohler E, Keysers C, Umilta MA, Fogassi L, Gallese V, Rizzolatti G. Hearing sounds, understanding actions: action representation in mirror neurons. Science. 2002 Aug 2;297(5582):846-8. doi: 10.1126/science.1070311.
- Results publication: PubMed 12937876Keysers C, Kohler E, Umilta MA, Nanetti L, Fogassi L, Gallese V. Audiovisual mirror neurons and action recognition. Exp Brain Res. 2003 Dec;153(4):628-36. doi: 10.1007/s00221-003-1603-5. Epub 2003 Aug 23.
- Results publication: PubMed 20445542Keysers C, Kaas JH, Gazzola V. Somatosensation in social perception. Nat Rev Neurosci. 2010 Jun;11(6):417-28. doi: 10.1038/nrn2833. Epub 2010 May 6.
- Results publication: PubMed 17503101Kaplan JT, Iacoboni M. Multimodal action representation in human left ventral premotor cortex. Cogn Process. 2007 Jun;8(2):103-13. doi: 10.1007/s10339-007-0165-z. Epub 2007 May 15.
- Results publication: PubMed 23583615Hetu S, Gregoire M, Saimpont A, Coll MP, Eugene F, Michon PE, Jackson PL. The neural network of motor imagery: an ALE meta-analysis. Neurosci Biobehav Rev. 2013 Jun;37(5):930-49. doi: 10.1016/j.neubiorev.2013.03.017. Epub 2013 Apr 10.
- Results publication: PubMed 26689088Fox NA, Bakermans-Kranenburg MJ, Yoo KH, Bowman LC, Cannon EN, Vanderwert RE, Ferrari PF, van IJzendoorn MH. Assessing human mirror activity with EEG mu rhythm: A meta-analysis. Psychol Bull. 2016 Mar;142(3):291-313. doi: 10.1037/bul0000031. Epub 2015 Dec 21.
- Results publication: PubMed 31299375Demas J, Bourguignon M, Perivier M, De Tiege X, Dinomais M, Van Bogaert P. Mu rhythm: State of the art with special focus on cerebral palsy. Ann Phys Rehabil Med. 2020 Oct;63(5):439-446. doi: 10.1016/j.rehab.2019.06.007. Epub 2019 Jul 9.
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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.
Giuseppina Sgandurra, PhD, MD principal investigator
IRCCS Fondazione Stella Maris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy (CP) and CP (Cerebral Palsy), run by IRCCS Fondazione Stella Maris at 1 site in Italy.
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 0 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. 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 Italy. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppina Sgandurra, PhD, MD (050/886233, gsgandurra@fsm.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurophysiological data (hdEEG) (time frame: one hour per session). 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 NCT07369193, which also lists 13 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 Apr 2026.