Parkinson DeseaseOPERANCT06920511
Cognitive Rehabilitation With Virtual Reality in Parkinson Disease
A study testing Cognitve rehabilitation with virtual reality and robotic arm in people with Parkinson Desease and Mild Cognitive Impairment (MCI), run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The OPERA Clinical Study is an interventional, single-arm, open-label pilot clinical study that aims to evaluate the usability of an innovative bio-cooperative robotic platform (PRoBio) for cognitive rehabilitation in patients with Parkinson's Disease (PD) and Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Desease, Mild Cognitive Impairment (MCI)
- What is being tested?
- Cognitve rehabilitation with virtual reality and robotic arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 31 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of mild Parkinson's Disease (Hoehn \& Yahr stage II-III);
- Diagnosis of Mild Cognitive Impairment (MCI) according to Litvan et al. (2012) criteria for PD-MCI;
- Age ≥ 18 years;
- Signed informed consent
Who cannot join
- Diagnosis of Parkinson's Disease Dementia, atypical parkinsonisms, secondary parkinsonisms, or mixed forms;
- Severe depressive syndrome
- Absence of signed informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated biO-cooPErative Robotic plAtform for Virtual Cognitive-motor Training in Parkinson's Disease
The OPERA Clinical Study is an interventional, single-arm, open-label pilot clinical study that aims to evaluate the usability of an innovative bio-cooperative robotic platform (PRoBio) for cognitive rehabilitation in patients with Parkinson's Disease (PD) and Mild Cognitive Impairment (MCI). The study focuses on assessing the effectiveness and acceptability of the system in a pilot study involving patients undergoing a structured cognitive rehabilitation program.
PRoBio is an advanced rehabilitation platform that integrates the TIAGo robotic system, developed by PAL Robotics, with the VRRS COMPACT virtual reality rehabilitation system, designed by Khymeia. TIAGo is provided by a robotic arm and RGB-D camera that allow the collection of biomechanical and psychophysiological data, which are then used to personalize the treatment through the cognitive tasks provided by the VRRS COMPACT. The pilot study involves patients with PD-MCI, who will undergo a four-week rehabilitation program with ProBio, consisting of three weekly sessions of virtual cognitive training. The primary objective is to assess the usability and compliance of the system by evaluating user experience, ease of interaction, and engagement levels among both patients and rehabilitation professionals, as well as evaluating its ability to monitor biomechanical and psychophysiological parameters during treatment. This assessment will be conducted using a multimodal sensor system, which includes an RGB-D camera integrated into the UCBM TIAGo robot and wearable sensors designed to measure heart rate, respiratory rate, and galvanic skin response. The data collected through these sensors will be analyzed offline to personalize cognitive rehabilitation treatments in subsequent sessions. Additionally, the study aims to evaluate the accuracy and response times of patients while performing cognitive exercises, as recorded by the VRRS system. Furthermore, the study will explore the potential effects of PRoBio treatment on the cognitive functions of patients with Parkinson's Disease and Mild Cognitive Impairment (PD-MCI) as a possible future rehabilitation to include in the clinical practice.
Read the detailed description
The pilot study will be conducted at two clinical centers, the Fondazione Don Carlo Gnocchi ONLUS sites in Sant'Angelo dei Lombardi (AV) and Florence (FI).
The first step involves obtaining informed consent from all participants. Following this, a baseline assessment (T0) will be carried out, including the collection of demographic and anamnesis data, as well as cognitive and psychological evaluations. These assessments will help confirm eligibility criteria and serve as a pre-treatment evaluation for enrolled patients. The assessment tools include the MDS-Unified Parkinson's Disease Rating Scale, the Parkinson's Disease Cognitive Rating Scale, the Stroop Color Word Test, the Trail Making Test (A and B), the Parkinson's Disease Questionnaire (PDQ-39), the 15-item Geriatric Depression Scale, and the Geriatric Anxiety Inventory.
Once baseline evaluations are completed, patients will begin a structured cognitive rehabilitation program using the ProBio platform, which integrates the UCBM TIAGo service robot with the VRRS COMPACT telerehabilitation system developed by Khymeia. The rehabilitation program will consist of three weekly sessions, each lasting 45 minutes, for a total duration of four weeks. The cognitive tasks and activities will be tailored to the individual patient's abilities to provide a personalized treatment plan aimed at improving specific cognitive functions. During the rehabilitation sessions, UCBM TIAGo will continuously monitor the patient's physical and emotional state, collecting data through advanced sensors and its integrated RGB-D camera. These data will be analyzed offline to adjust the complexity and intensity of exercises for subsequent sessions based on individual responses.
Throughout the treatment, several parameters will be recorded. The accuracy and response times in cognitive exercises will be documented in reports generated by the VRRS software. Biomechanical parameters, such as movement amplitude and speed, will be measured using the RGB-D camera, while psychophysiological parameters, including respiratory rate, heart rate, and skin conductance, will be monitored via wearable sensors. Based on these parameters, the VRRS system will provide real-time visual and vocal feedback to the patient regarding response accuracy and exercise execution. Additionally, at the end of each session, the bio-cooperative robot TIAGo will verbally interact with the patient to assess their experience, including perceived enjoyment, task comprehension, and ease of execution.
At the end of the four-week rehabilitation program, a final evaluation (T1) will be conducted using the same cognitive and psychological assessment tools applied at baseline. This will include the MDS-Unified Parkinson's Disease Rating Scale, the Parkinson's Disease Cognitive Rating Scale, the Stroop Color Word Test, the Trail Making Test, the Parkinson's Disease Questionnaire (PDQ-39), the 15-item Geriatric Depression Scale, and the Geriatric Anxiety Inventory. The study also aims to explore the potential of integrating robotic bio-cooperative platforms into routine clinical rehabilitation settings, providing insights into their feasibility and effectiveness for future large-scale applications.
- Conditions
- Parkinson Desease, Mild Cognitive Impairment (MCI)
- Being tested
- Cognitve rehabilitation with virtual reality and robotic arm
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitve rehabilitation with virtual reality and robotic armDevice
Also called TIAGo, COMPACT VRRS, Robotic Bio-Cooperative Training, Virtual Reality Rehabilitation with PRoBio
The intervention consists of a cognitive rehabilitation program using the PRoBio platform, a bio-cooperative robotic system integrating virtual reality and real-time multisensory feedback. The PRoBio platform includes a robotic arm (TIAGo), a virtual reality interface (VRRS), and sensors to monitor biomechanical, cognitive, and emotional parameters during training.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training with PRoBio in Parkinson's Disease | Experimental | Patients with Parkinson's Disease and Mild Cognitive Impairment will undergo a cognitive rehabilitation program using the PRoBio robotic platform. The intervention consists of 3 sessions per week (45 minutes each) for 4 weeks. The PRoBio system includes virtual reality exercises and real-time feedback based on motor and emotional responses. Receives: Device: Cognitve rehabilitation with virtual reality and robotic arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS) - Patient Reported Outcome
Assessment of system usability using the 10-item SUS scale. Scores range from 0 to 100; higher scores indicate better usability.
Measured: Week 4 (post-treatment, T1)
eHealth Usability Benchmarking Instrument (HUBBI)
Assessment of system usability using the HUBBI questionnaire. Items rated on a 7-point scale; higher scores indicate better usability.
Measured: Week 4 (post-treatment, T1)
User Experience Questionnaire - Short Version (UEQ-S)
Evaluation of pragmatic and hedonic user experience with the UEQ-S. Each item rated from -3 to +3; higher scores indicate more positive experience.
Measured: Week 4 (post-treatment, T1)
Technology Acceptance Model (TAM) and UTAUT Scores
Evaluation of perceived usefulness and ease of use via TAM and UTAUT scales. Items rated on 5-point Likert scales.
Measured: Week 4 (post-treatment, T1)
NASA Task Load Index (NASA-TLX)
Evaluation of cognitive workload using the NASA-TLX scale. Scores range from 0 to 100; higher scores indicate higher workload.
Measured: Week 4 (post-treatment, T1)
Secondary outcomes (8)
Session Attendance and Treatment Adherence
Evaluation of the acceptance of the PRoBio platform by patients and clinicians, based on session attendance, treatment adherence, and system usability for operators. Additionally, the ability of PRoBio to collect biomechanical and psychophysiological data during treatment will be assessed. These include response accuracy and reaction times (collected by VRRS), movement amplitude and velocity (via RGB-D camera), and physiological indicators (heart rate, respiratory rate, and skin conductance) recorded through wearable sensors. These data will be used offline to customize the rehabilitation sessions.
Measured: Weeks 1-4
Response Accuracy in Cognitive Tasks (VRRS Software)
Accuracy rate in exercises performed during each session, as recorded by VRRS.
Measured: Weeks 1-4
Reaction Times in Cognitive Tasks (VRRS Software)
Mean reaction times (ms) recorded during cognitive tasks using the PRoBio platform.
Measured: Weeks 1-4
Movement Amplitude (RGB-D Camera Analysis)
Mean amplitude of upper limb movements captured via RGB-D camera.
Measured: Weeks 1-4
Movement Velocity (RGB-D Camera Analysis)
Mean velocity of arm movements during tasks, as measured by RGB-D camera.
Measured: Weeks 1-4
Heart Rate During Sessions (Wearable Sensors)
Average heart rate recorded during rehabilitation sessions.
Measured: Weeks 1-4
Respiratory Rate During Sessions (Wearable Sensors)
Average respiratory rate recorded during sessions.
Measured: Weeks 1-4
Skin Conductance Level (SCL) During Sessions
Average SCL value measured by wearable sensors as indicator of emotional arousal.
Measured: Weeks 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 May 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DeseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The OPERA study is designed as a single-group interventional study. All participants are enrolled into one group and receive the same intervention, a cognitive rehabilitation program using the PRoBio platform. There are no comparison groups.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University, Khymeia Group S.r.l.
- Responsible party
- Principal investigator, Anna Estraneo, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Anna Estraneo, MD, Principal investigator, Fondazione Don Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920511
- Sponsor's protocol ID
- Opera
- Other IDs
- PNRR - AGE-IT SPOKE 1 e SPOKE
- Acronym
- OPERA
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) to be shared include demographic variables (age, gender, disease stage), usability and acceptability questionnaire scores, cognitive task performance (accuracy and reaction times), biomechanical parameters (e.g., movement amplitude and velocity), and psychophysiological data (e.g., heart rate, respiratory rate, skin conductance) collected during the intervention.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated biO-cooPErative Robotic plAtform for Virtual Cognitive-motor Training in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06920511
- Acronym / sponsor ID
- OPERA / Opera
- Conditions
- Parkinson Desease, Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University, Khymeia Group S.r.l.
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 9 Apr 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 OPERA Clinical Study is an interventional, single-arm, open-label pilot clinical study that aims to evaluate the usability of an innovative bio-cooperative robotic platform (PRoBio) for cognitive rehabilitation in patients with Parkinson's Disease (PD) and Mild Cognitive Impairment (MCI). The study focuses on assessing the effectiveness and acceptability of the system in a pilot study involving patients undergoing a structured cognitive rehabilitation program.
PRoBio is an advanced rehabilitation platform that integrates the TIAGo robotic system, developed by PAL Robotics, with the VRRS COMPACT virtual reality rehabilitation system, designed by Khymeia. TIAGo is provided by a robotic arm and RGB-D camera that allow the collection of biomechanical and psychophysiological data, which are then used to personalize the treatment through the cognitive tasks provided by the VRRS COMPACT. The pilot study involves patients with PD-MCI, who will undergo a four-week rehabilitation program with ProBio, consisting of three weekly sessions of virtual cognitive training. The primary objective is to assess the usability and compliance of the system by evaluating user experience, ease of interaction, and engagement levels among both patients and rehabilitation professionals, as well as evaluating its ability to monitor biomechanical and psychophysiological parameters during treatment. This assessment will be conducted using a multimodal sensor system, which includes an RGB-D camera integrated into the UCBM TIAGo robot and wearable sensors designed to measure heart rate, respiratory rate, and galvanic skin response. The data collected through these sensors will be analyzed offline to personalize cognitive rehabilitation treatments in subsequent sessions. Additionally, the study aims to evaluate the accuracy and response times of patients while performing cognitive exercises, as recorded by the VRRS system. Furthermore, the study will explore the potential effects of PRoBio treatment on the cognitive functions of patients with Parkinson's Disease and Mild Cognitive Impairment (PD-MCI) as a possible future rehabilitation to include in the clinical practice.
Detailed description
The pilot study will be conducted at two clinical centers, the Fondazione Don Carlo Gnocchi ONLUS sites in Sant'Angelo dei Lombardi (AV) and Florence (FI).
The first step involves obtaining informed consent from all participants. Following this, a baseline assessment (T0) will be carried out, including the collection of demographic and anamnesis data, as well as cognitive and psychological evaluations. These assessments will help confirm eligibility criteria and serve as a pre-treatment evaluation for enrolled patients. The assessment tools include the MDS-Unified Parkinson's Disease Rating Scale, the Parkinson's Disease Cognitive Rating Scale, the Stroop Color Word Test, the Trail Making Test (A and B), the Parkinson's Disease Questionnaire (PDQ-39), the 15-item Geriatric Depression Scale, and the Geriatric Anxiety Inventory.
Once baseline evaluations are completed, patients will begin a structured cognitive rehabilitation program using the ProBio platform, which integrates the UCBM TIAGo service robot with the VRRS COMPACT telerehabilitation system developed by Khymeia. The rehabilitation program will consist of three weekly sessions, each lasting 45 minutes, for a total duration of four weeks. The cognitive tasks and activities will be tailored to the individual patient's abilities to provide a personalized treatment plan aimed at improving specific cognitive functions. During the rehabilitation sessions, UCBM TIAGo will continuously monitor the patient's physical and emotional state, collecting data through advanced sensors and its integrated RGB-D camera. These data will be analyzed offline to adjust the complexity and intensity of exercises for subsequent sessions based on individual responses.
Throughout the treatment, several parameters will be recorded. The accuracy and response times in cognitive exercises will be documented in reports generated by the VRRS software. Biomechanical parameters, such as movement amplitude and speed, will be measured using the RGB-D camera, while psychophysiological parameters, including respiratory rate, heart rate, and skin conductance, will be monitored via wearable sensors. Based on these parameters, the VRRS system will provide real-time visual and vocal feedback to the patient regarding response accuracy and exercise execution. Additionally, at the end of each session, the bio-cooperative robot TIAGo will verbally interact with the patient to assess their experience, including perceived enjoyment, task comprehension, and ease of execution.
At the end of the four-week rehabilitation program, a final evaluation (T1) will be conducted using the same cognitive and psychological assessment tools applied at baseline. This will include the MDS-Unified Parkinson's Disease Rating Scale, the Parkinson's Disease Cognitive Rating Scale, the Stroop Color Word Test, the Trail Making Test, the Parkinson's Disease Questionnaire (PDQ-39), the 15-item Geriatric Depression Scale, and the Geriatric Anxiety Inventory. The study also aims to explore the potential of integrating robotic bio-cooperative platforms into routine clinical rehabilitation settings, providing insights into their feasibility and effectiveness for future large-scale applications.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The OPERA study is designed as a single-group interventional study. All participants are enrolled into one group and receive the same intervention, a cognitive rehabilitation program using the PRoBio platform. There are no comparison groups.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training with PRoBio in Parkinson's Disease | Experimental | Device: Cognitve rehabilitation with virtual reality and robotic armPatients with Parkinson's Disease and Mild Cognitive Impairment will undergo a cognitive rehabilitation program using the PRoBio robotic platform. The intervention consists of 3 sessions per week (45 minutes each) for 4 weeks. The PRoBio system includes virtual reality exercises and real-time feedback based on motor and emotional responses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of mild Parkinson's Disease (Hoehn \& Yahr stage II-III);
- Diagnosis of Mild Cognitive Impairment (MCI) according to Litvan et al. (2012) criteria for PD-MCI;
- Age ≥ 18 years;
- Signed informed consent
Key exclusion criteria (3 listed)
- Diagnosis of Parkinson's Disease Dementia, atypical parkinsonisms, secondary parkinsonisms, or mixed forms;
- Severe depressive syndrome
- Absence of signed informed consent
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 |
|---|---|---|
| Cognitve rehabilitation with virtual reality and robotic armAlso: TIAGo, COMPACT VRRS, Robotic Bio-Cooperative Training, Virtual Reality Rehabilitation with PRoBioThe intervention consists of a cognitive rehabilitation program using the PRoBio platform, a bio-cooperative robotic system integrating virtual reality and real-time multisensory feedback. The PRoBio platform includes a robotic arm (TIAGo), a virtual reality interface (VRRS), and sensors to monitor biomechanical, cognitive, and emotional parameters during training. | Device | Cognitive Training with PRoBio in Parkinson's Disease |
Primary outcome
System Usability Scale (SUS) - Patient Reported Outcome
Time frame: Week 4 (post-treatment, T1)
Assessment of system usability using the 10-item SUS scale. Scores range from 0 to 100; higher scores indicate better usability.
eHealth Usability Benchmarking Instrument (HUBBI)
Time frame: Week 4 (post-treatment, T1)
Assessment of system usability using the HUBBI questionnaire. Items rated on a 7-point scale; higher scores indicate better usability.
User Experience Questionnaire - Short Version (UEQ-S)
Time frame: Week 4 (post-treatment, T1)
Evaluation of pragmatic and hedonic user experience with the UEQ-S. Each item rated from -3 to +3; higher scores indicate more positive experience.
Technology Acceptance Model (TAM) and UTAUT Scores
Time frame: Week 4 (post-treatment, T1)
Evaluation of perceived usefulness and ease of use via TAM and UTAUT scales. Items rated on 5-point Likert scales.
NASA Task Load Index (NASA-TLX)
Time frame: Week 4 (post-treatment, T1)
Evaluation of cognitive workload using the NASA-TLX scale. Scores range from 0 to 100; higher scores indicate higher workload.
8 secondary outcomes
Session Attendance and Treatment Adherence
Time frame: Weeks 1-4
Response Accuracy in Cognitive Tasks (VRRS Software)
Time frame: Weeks 1-4
Reaction Times in Cognitive Tasks (VRRS Software)
Time frame: Weeks 1-4
Movement Amplitude (RGB-D Camera Analysis)
Time frame: Weeks 1-4
Movement Velocity (RGB-D Camera Analysis)
Time frame: Weeks 1-4
Heart Rate During Sessions (Wearable Sensors)
Time frame: Weeks 1-4
Respiratory Rate During Sessions (Wearable Sensors)
Time frame: Weeks 1-4
Skin Conductance Level (SCL) During Sessions
Time frame: Weeks 1-4
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 11 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) to be shared include demographic variables (age, gender, disease stage), usability and acceptability questionnaire scores, cognitive task performance (accuracy and reaction times), biomechanical parameters (e.g., movement amplitude and velocity), and psychophysiological data (e.g., heart rate, respiratory rate, skin conductance) collected during the intervention.
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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.
Anna Estraneo, MD principal investigator
Fondazione Don Gnocchi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitve rehabilitation with virtual reality and robotic arm in people with Parkinson Desease and Mild Cognitive Impairment (MCI), run by Fondazione Don Carlo Gnocchi ETS 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 4 inclusion and 3 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 11 Sep 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?
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?
System Usability Scale (SUS) - Patient Reported Outcome (time frame: Week 4 (post-treatment, T1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.