Cerebral PalsyNCT06769178
How Much Virtual Reality Intervention Improve the Balance of Patients With Cerebral Palsy
A study testing Virtual Reality based in people with Cerebral Palsy, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical study is to investigate how effective virtual reality applications are in adult cerebral palsy rehabilitation. The main questions it aims to answer are: Do virtual reality interventions (of Becure Balance and Becure Wesense Systems) improve balance and is this improvement reflected in the… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Virtual Reality based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2026to Jul 2027
- Phase
- Interventional
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being diagnosed with unilateral spastic type cerebral palsy (hemiplegic type) / Being between the ages of 18-30 / Being able to walk independently (GMFCS I-II) / Not having Botox application in the last six months / Not using any medication that will affect the study process
Who cannot join
- Having a history of epileptic attacks / Having >2 spasticity in any joint according to the modified Ashworth scale / Having severe depression according to the Beck Depression Inventory /Having hearing-vision problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yeditepe University
Istanbul, Ataşehir, 34758
Simay Atıcı, PT, MSc, 0216 578 00 00 ext. 3037, simayaticii@hotmail.com
Bayram Yılmaz, Prof. Dr., 0216 578 00 00, byilmaz@yeditepe.edu.tr
About this study
Official title: Effect of Virtual Reality-Based Interventions on Clinical and Neuroplasticity, Brain Functional Resting State Networks in Cerebral Palsy Rehabilitation
The purpose of this clinical study is to investigate how effective virtual reality applications are in adult cerebral palsy rehabilitation.
The main questions it aims to answer are:
Do virtual reality interventions (of Becure Balance and Becure Wesense Systems) improve balance and is this improvement reflected in the clinic? Is there a change in brain functional resting state networks after virtual reality interventions?
- Conditions
- Cerebral Palsy
- Being tested
- Virtual Reality based
- Keywords
- adult cerebral palsy, functional magnetic reasonance imaging, virtual reality, becure systems, balance, resting state functional magnetic reasonance imaging
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality basedOther
Also called Neurodevelopmental based
Participants will receive treatment by a specialist physiotherapist for a total of 16 sessions, 2 days a week on non-consecutive days for 8 weeks. Both groups will receive neurodevelopmental treatment (NGT) for 16 sessions. While the control group will receive traditional balance training in each session, the VR group will play virtual reality-based games.
| Study group | Role | What they receive |
|---|---|---|
| Serious Game Group | Experimental | BecureBalance and WesenseSystems will be used.Games'll be chosen to improve balance and empowerment,and game levels will be adjusted according to the condition of the participants.Balance Adventure is a game that involves transferring weight in 4 directions.At level 1,the goal is to reach the exit by collecting all the stars. At level 3,the goal is to collect stars on a moving surface and move the ball without dropping it.Balance Surf game is played with weight transfer from right to left and forward.The aim of the game is to earn points by steering the surfboard on the screen,collecting stars and gift wrap objects.Sizing Ball and Aerobat games are played by connecting a wearable sensor to the muscle group that the participants want to exercise.By calibrating this sensor, we can assume the angle we want is 0,and when more than the angle we set is made,movement will be revealed in the game.For this,lower extremity muscles will be exercised with these games by wearing a resistance band. Receives: Other: Virtual Reality based |
| Control Group | Other | Participants in the control group will receive a total of 16 sessions of structured NGT-based exercise applications prepared by the researchers.For this, involving balance and strengthening'll be applied, focusing mainly on lower extremity movements. For warm-up exercises, trunk rotation, shoulder rotation, hip rotation and toe-to-toe elevation and descent'll be performed for 10 minutes.Strengthening exercises'll mostly focus on the lower extremity muscles.These exercises'll be practiced for 20 minutes, and the participants'll be given the following exercises while the weight is tied. Each exercise'll be done in 2 sets of 10 repetitions.Balance exercises'll be practiced statically and dynamically for 20 minutes with 2 sets of 10 repetitions. Receives: Other: Virtual Reality based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength Assessment
Muscle strength is an important component of health. Muscle weakness is seen in the presence of neurologicaldiseases and therefore muscle strength measurement is important for general health assessment. The most common equipment or methods that provide quantitative measurements of strength, such as isokinetic and portable dynamometers, have been shown to provide valid and reliable measurements. The muscle strengths of the participants in the lower extremity (hip flexor, extensor, abductor and adductor, knee flexor and extensor, ankle dorsi-plantar flexor) muscle groups will be measured with a handheld dynamometer.
Measured: up to 8 weeks
Timed Up and Go Test (TUG)
TUG is a rapid test used in clinic as an outcome measure to assess functional mobility as well as static and dynamic balance. It's based on the length of time which takes for an individual to get up from a chair, walk 3 meters at a comfortable (or fastest) pace, turn (or touch the wall), walk to chair and sit down again.
Measured: up to 8 weeks
Berg Balance Scale (BBS)
The BBS, developed by Berg et al (1995) and used in the assessment of balance, is a four-point scale that rates patients' balance from easy to difficult (0: cannot do, 4: does independently). During the test consisting of 14 items, steps, rulers, stopwatches and chairs are used. The test evaluates postural control and fall risk. The maximum total score is 56 points. 0-20: high fall risk, 21-40: moderate fall risk, 41-56: low fall risk. The Turkish validity and reliability of the scale was made by Şahin et al (2008).
Measured: up to 8 weeks
Secondary outcomes (1)
fMRI scan
High-resolution (1 x 1 x 1 mm isotropic) sagittal 190 slices will be acquired with a T1-weighted imaging sequence (TR/TE: 7.7/3.7 ms;, FA: 8°; FOV: 256 x 256). Functional resting state data will be acquired with a single-shot echo planar imaging (EPI) sequence of 300 dynamic acquisitions consisting of 35 slices of 4 mm thickness (TR/TE: 2230/30 ms, FA: 77°; matrix: 80x80) and will last approximately 11 minutes. Magnetic field maps will be recorded in order to correct signal distortions caused by tissue inhomogeneities in the magnetic field during the analysis phase before functional acquisition. Participants will be asked to fix their gaze on a point by keeping their eyes open during functional acquisitions. Participants will be informed that they can close their eyes and rest during the other stages of the acquisitions. fMRI acquisitions will be completed in approximately 30 minutes, including the preparation stages. The MRI acquisition sequences will be as follows: Survey, Resting S
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start23 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769178
- Sponsor's protocol ID
- SimayA
- Status last verified
- Jul 2026
- First submitted
- 2 Oct 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
You SH, Jang SH, Kim YH, Kwon YH, Barrow I, Hallett M. Cortical reorganization induced by virtual reality therapy in a child with hemiparetic cerebral palsy. Dev Med Child Neurol. 2005 Sep;47(9):628-35.
PubMed 16138671Wimalasundera N, Stevenson VL. Cerebral palsy. Pract Neurol. 2016 Jun;16(3):184-94. doi: 10.1136/practneurol-2015-001184. Epub 2016 Feb 2.
PubMed 26837375Warnier N, Lambregts S, Port IV. Effect of Virtual Reality Therapy on Balance and Walking in Children with Cerebral Palsy: A Systematic Review. Dev Neurorehabil. 2020 Nov;23(8):502-518. doi: 10.1080/17518423.2019.1683907. Epub 2019 Nov 1.
PubMed 31674852Upadhyay J, Ansari MN, Samad A, Sayana A. Dysregulation of multiple signaling pathways: A possible cause of cerebral palsy. Exp Biol Med (Maywood). 2022 May;247(9):779-787. doi: 10.1177/15353702221081022. Epub 2022 Mar 7.
PubMed 35253451Reyes F, Niedzwecki C, Gaebler-Spira D. Technological Advancements in Cerebral Palsy Rehabilitation. Phys Med Rehabil Clin N Am. 2020 Feb;31(1):117-129. doi: 10.1016/j.pmr.2019.09.002. Epub 2019 Nov 6.
PubMed 31760985Reid LB, Pagnozzi AM, Fiori S, Boyd RN, Dowson N, Rose SE. Measuring neuroplasticity associated with cerebral palsy rehabilitation: An MRI based power analysis. Int J Dev Neurosci. 2017 May;58:17-25. doi: 10.1016/j.ijdevneu.2017.01.010. Epub 2017 Jan 24.
PubMed 28130065Papageorgiou E, De Beukelaer N, Simon-Martinez C, Mailleux L, Van Campenhout A, Desloovere K, Ortibus E. Structural Brain Lesions and Gait Pathology in Children With Spastic Cerebral Palsy. Front Hum Neurosci. 2020 Jul 9;14:275. doi: 10.3389/fnhum.2020.00275. eCollection 2020.
PubMed 32733223Papadelis C, Ahtam B, Feldman HA, AlHilani M, Tamilia E, Nimec D, Snyder B, Ellen Grant P, Im K. Altered White Matter Connectivity Associated with Intergyral Brain Disorganization in Hemiplegic Cerebral Palsy. Neuroscience. 2019 Feb 10;399:146-160. doi: 10.1016/j.neuroscience.2018.12.028. Epub 2018 Dec 26.
PubMed 30593919Jaatela J, Nurmi T, Vallinoja J, Maenpaa H, Sairanen V, Piitulainen H. Altered corpus callosum structure in adolescents with cerebral palsy: connection to gait and balance. Brain Struct Funct. 2023 Nov;228(8):1901-1915. doi: 10.1007/s00429-023-02692-1. Epub 2023 Aug 24.
PubMed 37615759Hawe RL, Sukal-Moulton T, Dewald JP. The effect of injury timing on white matter changes in the corpus callosum following unilateral brain injury. Neuroimage Clin. 2013 Aug 8;3:115-22. doi: 10.1016/j.nicl.2013.08.002. eCollection 2013.
PubMed 24179855Hajebrahimi F, Velioglu HA, Bayraktaroglu Z, Helvaci Yilmaz N, Hanoglu L. Clinical evaluation and resting state fMRI analysis of virtual reality based training in Parkinson's disease through a randomized controlled trial. Sci Rep. 2022 May 16;12(1):8024. doi: 10.1038/s41598-022-12061-3.
PubMed 35577874Hadzagic-Catibusic F, Avdagic E, Zubcevic S, Uzicanin S. Brain Lesions in Children with Unilateral Spastic Cerebral Palsy. Med Arch. 2017 Feb;71(1):7-11. doi: 10.5455/medarh.2017.71.7-11. Epub 2017 Feb 5.
PubMed 28428665Erten AB, Tarakci D, Cacan MA. The Effectiveness of Video-Based Game Exercise Therapy Applications in Pes Planus Rehabilitation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 11;12:e51772. doi: 10.2196/51772.
PubMed 37695657Coskun B, Ay S, Erol Barkana D, Bostanci H, Uzun I, Oktay AB, Tuncel B, Tarakci D. A physiological signal database of children with different special needs for stress recognition. Sci Data. 2023 Jun 14;10(1):382. doi: 10.1038/s41597-023-02272-2.
PubMed 37316526
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality-Based Interventions on Clinical and Neuroplasticity, Brain Functional Resting State Networks in Cerebral Palsy Rehabilitation
- ClinicalTrials.gov ID
- NCT06769178
- Acronym / sponsor ID
- SimayA
- Conditions
- Cerebral Palsy
- Keywords
- adult cerebral palsy, functional magnetic reasonance imaging, virtual reality, becure systems, balance, resting state functional magnetic reasonance imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Jan 2025 (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 purpose of this clinical study is to investigate how effective virtual reality applications are in adult cerebral palsy rehabilitation.
The main questions it aims to answer are:
Do virtual reality interventions (of Becure Balance and Becure Wesense Systems) improve balance and is this improvement reflected in the clinic? Is there a change in brain functional resting state networks after virtual reality interventions?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serious Game Group | Experimental | Other: Virtual Reality basedBecureBalance and WesenseSystems will be used.Games'll be chosen to improve balance and empowerment,and game levels will be adjusted according to the condition of the participants.Balance Adventure is a game that involves transferring weight in 4 directions.At level 1,the goal is to reach the exit by collecting all the stars. At level 3,the goal is to collect stars on a moving surface and move the ball without dropping it.Balance Surf game is played with weight transfer from right to left and forward.The aim of the game is to earn points by steering the surfboard on the screen,collecting stars and gift wrap objects.Sizing Ball and Aerobat games are played by connecting a wearable sensor to the muscle group that the participants want to exercise.By calibrating this sensor, we can assume the angle we want is 0,and when more than the angle we set is made,movement will be revealed in the game.For this,lower extremity muscles will be exercised with these games by wearing a resistance band. |
| Control Group | Other | Other: Virtual Reality basedParticipants in the control group will receive a total of 16 sessions of structured NGT-based exercise applications prepared by the researchers.For this, involving balance and strengthening'll be applied, focusing mainly on lower extremity movements. For warm-up exercises, trunk rotation, shoulder rotation, hip rotation and toe-to-toe elevation and descent'll be performed for 10 minutes.Strengthening exercises'll mostly focus on the lower extremity muscles.These exercises'll be practiced for 20 minutes, and the participants'll be given the following exercises while the weight is tied. Each exercise'll be done in 2 sets of 10 repetitions.Balance exercises'll be practiced statically and dynamically for 20 minutes with 2 sets of 10 repetitions. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Being diagnosed with unilateral spastic type cerebral palsy (hemiplegic type) / Being between the ages of 18-30 / Being able to walk independently (GMFCS I-II) / Not having Botox application in the last six months / Not using any medication that will affect the study process
Key exclusion criteria (1 listed)
- Having a history of epileptic attacks / Having >2 spasticity in any joint according to the modified Ashworth scale / Having severe depression according to the Beck Depression Inventory /Having hearing-vision problems
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 |
|---|---|---|
| Virtual Reality basedAlso: Neurodevelopmental basedParticipants will receive treatment by a specialist physiotherapist for a total of 16 sessions, 2 days a week on non-consecutive days for 8 weeks. Both groups will receive neurodevelopmental treatment (NGT) for 16 sessions. While the control group will receive traditional balance training in each session, the VR group will play virtual reality-based games. | Other | Control Group, Serious Game Group |
Primary outcome
Muscle Strength Assessment
Time frame: up to 8 weeks
Muscle strength is an important component of health. Muscle weakness is seen in the presence of neurologicaldiseases and therefore muscle strength measurement is important for general health assessment. The most common equipment or methods that provide quantitative measurements of strength, such as isokinetic and portable dynamometers, have been shown to provide valid and reliable measurements. The muscle strengths of the participants in the lower extremity (hip flexor, extensor, abductor and adductor, knee flexor and extensor, ankle dorsi-plantar flexor) muscle groups will be measured with a handheld dynamometer.
Timed Up and Go Test (TUG)
Time frame: up to 8 weeks
TUG is a rapid test used in clinic as an outcome measure to assess functional mobility as well as static and dynamic balance. It's based on the length of time which takes for an individual to get up from a chair, walk 3 meters at a comfortable (or fastest) pace, turn (or touch the wall), walk to chair and sit down again.
Berg Balance Scale (BBS)
Time frame: up to 8 weeks
The BBS, developed by Berg et al (1995) and used in the assessment of balance, is a four-point scale that rates patients' balance from easy to difficult (0: cannot do, 4: does independently). During the test consisting of 14 items, steps, rulers, stopwatches and chairs are used. The test evaluates postural control and fall risk. The maximum total score is 56 points. 0-20: high fall risk, 21-40: moderate fall risk, 41-56: low fall risk. The Turkish validity and reliability of the scale was made by Şahin et al (2008).
1 secondary outcome
fMRI scan
Time frame: up to 8 weeks
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 30 Jul 2026.
- Background: PubMed 16138671You SH, Jang SH, Kim YH, Kwon YH, Barrow I, Hallett M. Cortical reorganization induced by virtual reality therapy in a child with hemiparetic cerebral palsy. Dev Med Child Neurol. 2005 Sep;47(9):628-35.
- Background: PubMed 26837375Wimalasundera N, Stevenson VL. Cerebral palsy. Pract Neurol. 2016 Jun;16(3):184-94. doi: 10.1136/practneurol-2015-001184. Epub 2016 Feb 2.
- Background: PubMed 31674852Warnier N, Lambregts S, Port IV. Effect of Virtual Reality Therapy on Balance and Walking in Children with Cerebral Palsy: A Systematic Review. Dev Neurorehabil. 2020 Nov;23(8):502-518. doi: 10.1080/17518423.2019.1683907. Epub 2019 Nov 1.
- Background: PubMed 35253451Upadhyay J, Ansari MN, Samad A, Sayana A. Dysregulation of multiple signaling pathways: A possible cause of cerebral palsy. Exp Biol Med (Maywood). 2022 May;247(9):779-787. doi: 10.1177/15353702221081022. Epub 2022 Mar 7.
- Background: PubMed 31760985Reyes F, Niedzwecki C, Gaebler-Spira D. Technological Advancements in Cerebral Palsy Rehabilitation. Phys Med Rehabil Clin N Am. 2020 Feb;31(1):117-129. doi: 10.1016/j.pmr.2019.09.002. Epub 2019 Nov 6.
- Background: PubMed 28130065Reid LB, Pagnozzi AM, Fiori S, Boyd RN, Dowson N, Rose SE. Measuring neuroplasticity associated with cerebral palsy rehabilitation: An MRI based power analysis. Int J Dev Neurosci. 2017 May;58:17-25. doi: 10.1016/j.ijdevneu.2017.01.010. Epub 2017 Jan 24.
- Background: PubMed 32733223Papageorgiou E, De Beukelaer N, Simon-Martinez C, Mailleux L, Van Campenhout A, Desloovere K, Ortibus E. Structural Brain Lesions and Gait Pathology in Children With Spastic Cerebral Palsy. Front Hum Neurosci. 2020 Jul 9;14:275. doi: 10.3389/fnhum.2020.00275. eCollection 2020.
- Background: PubMed 30593919Papadelis C, Ahtam B, Feldman HA, AlHilani M, Tamilia E, Nimec D, Snyder B, Ellen Grant P, Im K. Altered White Matter Connectivity Associated with Intergyral Brain Disorganization in Hemiplegic Cerebral Palsy. Neuroscience. 2019 Feb 10;399:146-160. doi: 10.1016/j.neuroscience.2018.12.028. Epub 2018 Dec 26.
- Background: PubMed 37615759Jaatela J, Nurmi T, Vallinoja J, Maenpaa H, Sairanen V, Piitulainen H. Altered corpus callosum structure in adolescents with cerebral palsy: connection to gait and balance. Brain Struct Funct. 2023 Nov;228(8):1901-1915. doi: 10.1007/s00429-023-02692-1. Epub 2023 Aug 24.
- Background: PubMed 24179855Hawe RL, Sukal-Moulton T, Dewald JP. The effect of injury timing on white matter changes in the corpus callosum following unilateral brain injury. Neuroimage Clin. 2013 Aug 8;3:115-22. doi: 10.1016/j.nicl.2013.08.002. eCollection 2013.
- Background: PubMed 35577874Hajebrahimi F, Velioglu HA, Bayraktaroglu Z, Helvaci Yilmaz N, Hanoglu L. Clinical evaluation and resting state fMRI analysis of virtual reality based training in Parkinson's disease through a randomized controlled trial. Sci Rep. 2022 May 16;12(1):8024. doi: 10.1038/s41598-022-12061-3.
- Background: PubMed 28428665Hadzagic-Catibusic F, Avdagic E, Zubcevic S, Uzicanin S. Brain Lesions in Children with Unilateral Spastic Cerebral Palsy. Med Arch. 2017 Feb;71(1):7-11. doi: 10.5455/medarh.2017.71.7-11. Epub 2017 Feb 5.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality based in people with Cerebral Palsy, run by Yeditepe University at 1 site in Turkey (Türkiye).
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 1 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 30 Jul 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 Turkey (Türkiye). 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 Simay Atıcı, PhD C (+902165780000 ext. 3037, simayaticii@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength Assessment (time frame: up to 8 weeks). 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 NCT06769178, which also lists 14 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 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.