StrokeNCT07184892
Effects of Different Modes of Action Observation Therapy on Swallowing Function After Stroke: a Study Based on fNIRS
A study testing Daily life actual swallowing movement observation therapy, Video swallowing action observation therapy and Traditional swallowing training in people with Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Dysphagia is one of the most common symptoms of stroke patients, which seriously affects the quality of life of patients and delays the progress of rehabilitation. At present, the commonly used clinical swallowing treatment methods can achieve certain therapeutic effects, but the treatment effect of some patients is… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Daily life actual swallowing movement observation therapy, Video swallowing action observation therapy and Traditional swallowing training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2025to 5 Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1: 1.n accordance with the diagnostic criteria formulated by the Fourth National Academic Conference on Cerebrovascular disease;
- 2: 2.Dysphagia was detected by water swallowing test;
- 3: 3.First onset, course of disease within 6 months, the condition is stable;
- 4: 4.Mini-mental state examination (MMSE) score, literacy >=17 points, primary education >=20 points, secondary education >=24 points, can understand and cooperate with treatment;
- 5: 5.Have a certain degree of sitting balance ability, can maintain a sitting position for 30 minutes;
- 6: 6.Aged 18-80 years old;
- 7: 7.The patient was informed and consented to this study, and the patient's family was informed and trained, and could cooperate with the adjuvant treatment of swallowing movement observation therapy in daily life.
Who cannot join
- 1: Patients with impaired swallowing function due to other reasons;
- 2: Presence of tumors or other lesions in the mouth or throat;
- 3: Visual and hearing dysfunction;
- 4: The presence of agnosia, apraxia or unilateral neglect;
- 5: Severe cognitive impairment and mental and emotional instability can not cooperate with treatment;
- 6: Implantation or retention of ferromagnetic metals in the brain.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital
Jinan, Shandong, 250000
Yanping Ma, 86-18560083615, 1587052536@qq.com
Yonghui Wang, 86-18560083581, yonghuiw6606@126.com
About this study
Dysphagia is one of the most common symptoms of stroke patients, which seriously affects the quality of life of patients and delays the progress of rehabilitation. At present, the commonly used clinical swallowing treatment methods can achieve certain therapeutic effects, but the treatment effect of some patients is still not ideal. Therefore, we need to explore more and more effective treatment methods to improve the swallowing function of patients. Action observation therapy, which was developed based on the mirror neuron theory, has been widely used in the rehabilitation of limb motor function, and its therapeutic effect has been verified by a large number of clinical trials. There are few clinical studies on action observation therapy in swallowing function rehabilitation, and most of the current studies use swallowing videos to allow patients to observe actions, and then guide patients to imitate actions. Some studies have found that oral mirror neurons can be formed in the context of familiar environment, people and emotional communication. Therefore, this study proposes a new mode of action observation therapy for dysphagia, that is, to observe the real swallowing movement in actual daily life, in order to better improve the swallowing function of stroke patients with dysphagia.
This study was a single-center, assessor-blinded, randomized controlled study. After enrollment, all patients received swallowing assessment, including scale assessment (WST, FOIS, SSA, BMI, SWAL-QOL, VAS satisfaction survey, KVIQ motor imagery assessment, total oral intake/eating time), neck ultrasound and FNIRS brain function assessment. According to the random number table method, the patients were divided into three groups, A: control group, B: video swallowing movement observation therapy group, C: daily actual swallowing movement observation therapy group. All three groups were given routine swallowing function training. In group B, action observation therapy with video was added, that is, watching a video of swallowing action with sound, and then performing simulated swallowing action. Group C added the actual swallowing movement observation therapy in daily life, that is, in actual daily life, to observe the real eating and swallowing movement of relatives, and then imitate the swallowing movement. The training sessions were 30min each time, once a day, 5 days a week, for a total of 3 weeks. After the treatment, the scale assessment, neck ultrasound and FNIRS brain function assessment were performed again.
- Conditions
- Stroke
- Being tested
- Daily life actual swallowing movement observation therapy, Video swallowing action observation therapy, Traditional swallowing training
- Keywords
- stroke, action observation, mirror neurons, Dysphagia, swallowing function
- Medical subject headings
- Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily life actual swallowing movement observation therapyBehavioural
This group adds the therapy of observing actual swallowing movements in daily life, that is, in real daily life, observing the real eating and swallowing movements of relatives. They select meals that the patient likes or those that are complete in color, aroma and taste and look appetizing. The swallowing movements should be as slow and exaggerated as possible, and a look of savoring and enjoying the food should be shown, so that the patient can better observe the movements of the mouth and larynx during swallowing. Then, the patient imitates the swallowing movements.
Video swallowing action observation therapyBehavioural
Video swallowing action observation therapy
Traditional swallowing trainingBehavioural
Traditional swallowing training
| Study group | Role | What they receive |
|---|---|---|
| Video swallowing action observation therapy | Active comparator | On the basis of traditional swallowing training, this group adds video-assisted movement observation therapy, that is, watching swallowing movement videos with sound and then performing simulated swallowing movements. Receives: Behavioral: Video swallowing action observation therapy |
| Daily life actual swallowing action observation therapy | Experimental | On the basis of traditional swallowing training, this group adds the practice of observing the real eating and swallowing actions of relatives in actual daily life, and then imitating those swallowing actions. Receives: Behavioral: Daily life actual swallowing movement observation therapy |
| Traditional swallowing training | Active comparator | Routine swallowing function training includes indirect training (basic training) and direct training (feeding training). Indirect training includes but is not limited to training for the muscle strength and range of motion of swallowing muscles, training for inducing swallowing reflexes, breathing training, compensatory swallowing training, and airway protection training. Direct training involves the eating environment, body position, food selection, the amount and speed of each mouthful of food, as well as the compensatory skills commonly used during the eating process. Receives: Behavioral: Traditional swallowing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Oral Intake Scale（FOIS）
This scale is divided into 7 levels in total, which is used to assess the oral feeding ability of the subjects. The higher the level, the better the function.
Level 1: Unable to take food orally; Level 2: Dependent on tube feeding, able to attempt very small amounts of food or liquids orally; Level 3: Dependent on tube feeding, able to take food or liquids of a single texture orally; Level 4: Completely able to take food of a single texture orally; Level 5: Completely able to take food of multiple textures orally, but requiring special preparation or compensatory measures; Level 6: Completely able to take food orally without special preparation, but with specific food restrictions; Level 7: Completely able to take food orally without any restrictions.
Measured: Assessment before intervention and 3 weeks after intervention after enrollment.
Secondary outcomes (8)
Body Mass Index（BMI）
Calculation method for the weight (kg) divided by the square of height (meters).
Measured: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Through the mouth eating/total time of food intake
The time required for patients to eat a given amount of food was recorded.
Measured: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
The neck ultrasound
The probe of ultrosound will be placed in the middle of the neck, paralled to the sagittal line. Record the video of participant drinking 1ml water, the distance between hyoid and chin at rest minus distance during hyoid and chin are nerest. Repeated three times, and the mean value is further into analysis.
Measured: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Score of Water swallow test
The patient sat in a upright position and drank 30 ml of warm water. The time required and cough were observed. On a scale of 1-5, the higher the rating, the worse the function.
Measured: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
functional near - infrared spectroscopy（fNIRS）
Subjects were calm fNIRS tests 10 ~ 15 minutes rest again, the subjects keep head motionless, resting state, task state data.
Measured: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Kinesthetic and Visual Imagery Questionnaire（KVIQ) score
Subjects were seated and, as requested by the examiner, actually performed motor movements: forward shoulder flexion, finger opposition, forward trunk flexion, hip abduction, and foot tapping. The subject returned to the starting position and imagined the motor action that had actually been performed, but without moving the body. Visual imagery was assessed first, followed by motor imagery. The minimum score of KVIQ-10 is 10 points, and the maximum score is 50 points.
Measured: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Visual analogue scale（VAS）satisfaction survey score
VAS is mainly used to evaluate the degree of pain of patients, and the principle of VAS score can be used for reference when using VAS score for satisfaction investigation. Prepare a 10cm straight line with one end marked "0" to indicate dissatisfaction; The other end is marked with a "10", indicating great satisfaction.
Measured: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
swallowing-quality of life（SWAL-QOL）scale score
A total of 44 questions were classified into 11 dimensions: psychological burden, eating time, appetite, food choice, language communication, fear of eating, mental health, social interaction, fatigue, sleep and swallowing symptoms. Each item is scored by Likert 5-level scoring method (1-5 points correspond to 1-5 points), with a total score of 44 to 220 points. The higher the score, the better the quality of life.
Measured: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start6 Jan 2025
- Primary completion5 Jan 2027 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184892
- Sponsor's protocol ID
- KYLL-202406-003-1
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang C, Li X, Wang H. Application of action observation therapy in stroke rehabilitation: A systematic review. Brain Behav. 2023 Aug;13(8):e3157. doi: 10.1002/brb3.3157. Epub 2023 Jul 21.
PubMed 37480161Zeng M, Wang Z, Chen X, Shi M, Zhu M, Ma J, Yao Y, Cui Y, Wu H, Shen J, Xie L, Fu J, Gu X. The Effect of Swallowing Action Observation Therapy on Resting fMRI in Stroke Patients with Dysphagia. Neural Plast. 2023 Apr 21;2023:2382980. doi: 10.1155/2023/2382980. eCollection 2023.
PubMed 37124873Ferrari PF, Gerbella M, Coude G, Rozzi S. Two different mirror neuron networks: The sensorimotor (hand) and limbic (face) pathways. Neuroscience. 2017 Sep 1;358:300-315. doi: 10.1016/j.neuroscience.2017.06.052. Epub 2017 Jul 4.
PubMed 28687313Jing YH, Lin T, Li WQ, Wu C, Li X, Ding Q, Wu MF, Xu GQ, Lan Y. Comparison of Activation Patterns in Mirror Neurons and the Swallowing Network During Action Observation and Execution: A Task-Based fMRI Study. Front Neurosci. 2020 Aug 21;14:867. doi: 10.3389/fnins.2020.00867. eCollection 2020.
PubMed 32973431
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Modes of Action Observation Therapy on Swallowing Function After Stroke: a Study Based on fNIRS
- ClinicalTrials.gov ID
- NCT07184892
- Acronym / sponsor ID
- KYLL-202406-003-1
- Conditions
- Stroke
- Keywords
- stroke, action observation, mirror neurons, Dysphagia, swallowing function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 5 Jan 2027 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 22 Sep 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.
Dysphagia is one of the most common symptoms of stroke patients, which seriously affects the quality of life of patients and delays the progress of rehabilitation. At present, the commonly used clinical swallowing treatment methods can achieve certain therapeutic effects, but the treatment effect of some patients is still not ideal. Therefore, we need to explore more and more effective treatment methods to improve the swallowing function of patients. Action observation therapy, which was developed based on the mirror neuron theory, has been widely used in the rehabilitation of limb motor function, and its therapeutic effect has been verified by a large number of clinical trials. There are few clinical studies on action observation therapy in swallowing function rehabilitation, and most of the current studies use swallowing videos to allow patients to observe actions, and then guide patients to imitate actions. Some studies have found that oral mirror neurons can be formed in the context of familiar environment, people and emotional communication. Therefore, this study proposes a new mode of action observation therapy for dysphagia, that is, to observe the real swallowing movement in actual daily life, in order to better improve the swallowing function of stroke patients with dysphagia.
This study was a single-center, assessor-blinded, randomized controlled study. After enrollment, all patients received swallowing assessment, including scale assessment (WST, FOIS, SSA, BMI, SWAL-QOL, VAS satisfaction survey, KVIQ motor imagery assessment, total oral intake/eating time), neck ultrasound and FNIRS brain function assessment. According to the random number table method, the patients were divided into three groups, A: control group, B: video swallowing movement observation therapy group, C: daily actual swallowing movement observation therapy group. All three groups were given routine swallowing function training. In group B, action observation therapy with video was added, that is, watching a video of swallowing action with sound, and then performing simulated swallowing action. Group C added the actual swallowing movement observation therapy in daily life, that is, in actual daily life, to observe the real eating and swallowing movement of relatives, and then imitate the swallowing movement. The training sessions were 30min each time, once a day, 5 days a week, for a total of 3 weeks. After the treatment, the scale assessment, neck ultrasound and FNIRS brain function assessment were performed again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video swallowing action observation therapy | Active comparator | Behavioral: Video swallowing action observation therapyOn the basis of traditional swallowing training, this group adds video-assisted movement observation therapy, that is, watching swallowing movement videos with sound and then performing simulated swallowing movements. |
| Daily life actual swallowing action observation therapy | Experimental | Behavioral: Daily life actual swallowing movement observation therapyOn the basis of traditional swallowing training, this group adds the practice of observing the real eating and swallowing actions of relatives in actual daily life, and then imitating those swallowing actions. |
| Traditional swallowing training | Active comparator | Behavioral: Traditional swallowing trainingRoutine swallowing function training includes indirect training (basic training) and direct training (feeding training). Indirect training includes but is not limited to training for the muscle strength and range of motion of swallowing muscles, training for inducing swallowing reflexes, breathing training, compensatory swallowing training, and airway protection training. Direct training involves the eating environment, body position, food selection, the amount and speed of each mouthful of food, as well as the compensatory skills commonly used during the eating process. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1: 1.n accordance with the diagnostic criteria formulated by the Fourth National Academic Conference on Cerebrovascular disease;
- 2: 2.Dysphagia was detected by water swallowing test;
- 3: 3.First onset, course of disease within 6 months, the condition is stable;
- 4: 4.Mini-mental state examination (MMSE) score, literacy >=17 points, primary education >=20 points, secondary education >=24 points, can understand and cooperate with treatment;
- 5: 5.Have a certain degree of sitting balance ability, can maintain a sitting position for 30 minutes;
Key exclusion criteria (6 listed)
- 1: Patients with impaired swallowing function due to other reasons;
- 2: Presence of tumors or other lesions in the mouth or throat;
- 3: Visual and hearing dysfunction;
- 4: The presence of agnosia, apraxia or unilateral neglect;
- 5: Severe cognitive impairment and mental and emotional instability can not cooperate with treatment;
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 |
|---|---|---|
| Daily life actual swallowing movement observation therapyThis group adds the therapy of observing actual swallowing movements in daily life, that is, in real daily life, observing the real eating and swallowing movements of relatives. They select meals that the patient likes or those that are complete in color, aroma and taste and look appetizing. The swallowing movements should be as slow and exaggerated as possible, and a look of savoring and enjoying the food should be shown, so that the patient can better observe the movements of the mouth and larynx during swallowing. Then, the patient imitates the swallowing movements. | Behavioural | Daily life actual swallowing action observation therapy |
| Video swallowing action observation therapyVideo swallowing action observation therapy | Behavioural | Video swallowing action observation therapy |
| Traditional swallowing trainingTraditional swallowing training | Behavioural | Traditional swallowing training |
Primary outcome
Functional Oral Intake Scale（FOIS）
Time frame: Assessment before intervention and 3 weeks after intervention after enrollment.
This scale is divided into 7 levels in total, which is used to assess the oral feeding ability of the subjects. The higher the level, the better the function. Level 1: Unable to take food orally; Level 2: Dependent on tube feeding, able to attempt very small amounts of food or liquids orally; Level 3: Dependent on tube feeding, able to take food or liquids of a single texture orally; Level 4: Completely able to take food of a single texture orally; Level 5: Completely able to take food of multiple textures orally, but requiring special preparation or compensatory measures; Level 6: Completely able to take food orally without special preparation, but with specific food restrictions; Level 7: Completely able to take food orally without any restrictions.
8 secondary outcomes
Body Mass Index（BMI）
Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Through the mouth eating/total time of food intake
Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
The neck ultrasound
Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Score of Water swallow test
Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
functional near - infrared spectroscopy（fNIRS）
Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Kinesthetic and Visual Imagery Questionnaire（KVIQ) score
Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
Visual analogue scale（VAS）satisfaction survey score
Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
swallowing-quality of life（SWAL-QOL）scale score
Time frame: Assessments will be conducted after enrollment but before intervention, and three weeks after the intervention.
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 22 Sep 2025.
- Results publication: PubMed 37480161Zhang C, Li X, Wang H. Application of action observation therapy in stroke rehabilitation: A systematic review. Brain Behav. 2023 Aug;13(8):e3157. doi: 10.1002/brb3.3157. Epub 2023 Jul 21.
- Results publication: PubMed 37124873Zeng M, Wang Z, Chen X, Shi M, Zhu M, Ma J, Yao Y, Cui Y, Wu H, Shen J, Xie L, Fu J, Gu X. The Effect of Swallowing Action Observation Therapy on Resting fMRI in Stroke Patients with Dysphagia. Neural Plast. 2023 Apr 21;2023:2382980. doi: 10.1155/2023/2382980. eCollection 2023.
- Results publication: PubMed 28687313Ferrari PF, Gerbella M, Coude G, Rozzi S. Two different mirror neuron networks: The sensorimotor (hand) and limbic (face) pathways. Neuroscience. 2017 Sep 1;358:300-315. doi: 10.1016/j.neuroscience.2017.06.052. Epub 2017 Jul 4.
- Results publication: PubMed 32973431Jing YH, Lin T, Li WQ, Wu C, Li X, Ding Q, Wu MF, Xu GQ, Lan Y. Comparison of Activation Patterns in Mirror Neurons and the Swallowing Network During Action Observation and Execution: A Task-Based fMRI Study. Front Neurosci. 2020 Aug 21;14:867. doi: 10.3389/fnins.2020.00867. eCollection 2020.
- Application of action observation therapy in stroke rehabilitation: A systematic reviewLink provided by the sponsor.
- The Effect of Swallowing Action Observation Therapy on Resting fMRI in Stroke Patients with DysphagiaLink provided by the sponsor.
- Two different mirror neuron networks: The sensorimotor (hand) and limbic (face) pathwaysLink provided by the sponsor.
- Comparison of Activation Patterns in Mirror Neurons and the Swallowing Network During Action Observation and Execution: A Task-Based fMRI StudyLink provided by the sponsor.
- 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 Daily life actual swallowing movement observation therapy, Video swallowing action observation therapy and Traditional swallowing training in people with Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
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 7 inclusion and 6 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 22 Sep 2025. 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 China. 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 艳平 Yanping Ma (86-18560083615, 1587052536@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Oral Intake Scale（FOIS） (time frame: Assessment before intervention and 3 weeks after intervention after enrollment.). 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 NCT07184892, which also lists 4 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 22 Sep 2025.