Post-Stroke Cognitive Impairment (PSCI)NCT07208019
Electroacupuncture Treatment for Post-stroke Cognitive Impairment
A study testing Acupuncture in people with Post-Stroke Cognitive Impairment (PSCI), run by Ruijie Ma at 5 sites in China.
Trial summary
Stroke is a global public health issue, and it has become a leading cause of death and disability in China. With the rapid aging of the Chinese population, its incidence rate is continuously rising. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Post-Stroke Cognitive Impairment (PSCI)
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 5 sitesChina
- Study dates
- 5 Oct 2025to 30 Mar 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the Western diagnostic criteria for vascular cognitive impairment outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Vascular Cognitive Impairment (2024 Edition)" developed by the Vascular Cognitive Impairment Branch of the Chinese Stroke Society.
- Meets the traditional Chinese medicine diagnostic criteria for vascular cognitive impairment in the "Guidelines for Traditional Chinese Medicine Diagnosis and Treatment of Vascular Mild Cognitive Impairment (2024)";
- The Mini Mental State Examination (MMSE) score ranges from 12-24, while the Montreal Cognitive Assessment (MoCA) score is below 24; Having cognitive impairment but not reaching the level of severe dementia; The National Institutes of Health Stroke Scale (NIHSS) score is ≤ 8 points; The Early Dementia Screening Scale (Ascertain Dementia 8, AD-8) score is less than 2 points;
- Age between 35-80 years old;
- Have basic communication skills, with Mandarin as the main language (communication language is sufficient), and have at least one stable caregiver;
- Sign the informed consent form.
Who cannot join
- Merge serious primary chronic diseases such as heart, liver, kidney, endocrine system, and hematopoietic system, as well as severe cardiovascular and cerebrovascular diseases;
- Skin diseases or scar constitution such as herpes and ulceration are easy to appear on the body surface, which is not suitable for acupuncture and moxibustion treatment;
- Not suitable for repetitive MRI examinations, such as claustrophobia, arterial aneurysm embolization, etc;
- Patients with cognitive impairment or other severe neurological or mental disorders prior to the onset of this illness, and unstable control;
- Patients identified by other clinical trial personnel as unsuitable for this study;
- Participated in clinical research on related diseases in the past 3 months;
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310006
Fengjia Ni, 19816878056, 873962564@qq.com
- Not yet recruiting
Hangzhou Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, 310007
Liping Li, 13857161334, michelleli2000@163.com
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Lusha Tong, 15868171218, rosa00tong@163.com
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310053
Kun Yan, +86 28 8542 4855, zslunli@163.com
Ruijie Ma, +86 18057102851, 20071028@zcmu.edu.cn
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 314408
Xinyun Li, 18069783240, lxyjasmine2010@163.com
About this study
Official title: Study on the Key Technology of Acupoint Modulation-based Brain Electric Field Therapy for the Treatment of Post-stroke Cognitive Impairment
Stroke is a global public health issue, and it has become a leading cause of death and disability in China. With the rapid aging of the Chinese population, its incidence rate is continuously rising. According to the "China Stroke Prevention and Treatment Report (2023)", on average, one person experiences a new or recurrent stroke every 10 seconds in China, and one person dies from stroke every 28 seconds. Currently, there are 4 million new stroke cases in China each year, with 12.42 million individuals aged 40 and above currently suffering from stroke, and the affected population is showing a trend of younger onset. Among survivors, approximately 75% suffer from residual disabilities, and 40% have severe disabilities. Consequently, patient families will experience significant economic losses and physical and psychological pain.
Post-Stroke Cognitive Impairment (PSCI) is a common complication of stroke, where patients develop cognitive impairment within six months after the stroke event that meets the diagnostic criteria for cognitive impairment. PSCI is defined as a clinical phenomenon secondary to stroke events, with cognitive decline as its core characteristic. Such impairments encompass cognitive dysfunction caused by various stroke types and are one of the main determinants of functional dependency in post-stroke survivors. The prevalence of PSCI within six months is approximately 30% to 50%, with 10% progressing to dementia. Additionally, PSCI patients face a high risk of death, with up to 61% dying within five years. Countries worldwide have launched targeted guidelines, calling for increased attention and investment in this major complication. However, current treatments for PSCI are still limited to secondary prevention measures for stroke and drugs for treating Alzheimer's disease-like conditions, all lacking high-level clinical evidence. Therefore, effective treatments are urgently needed to improve patient outcomes.
Read more
PSCI is a dynamically evolving process, with individual differences in its occurrence time, influencing factors, clinical manifestations, and recovery prognosis. The unique diagnostic system of traditional Chinese medicine may assist in analyzing the disease progression of PSCI. The study of the patterns of syndrome evolution can help explain and provide reference for treatment. Currently, there are no specific drugs for treating PSCI, and relevant drug treatments lack high-level evidence. In recent years, with the development of imaging, artificial intelligence, and electromagnetic physics, non-pharmacological therapies have gradually become one of the research hotspots in the field of PSCI. It is worth noting that non-invasive brain stimulation, represented by transcranial electrical stimulation, is a therapy that directly acts on the brain lesions of PSCI and is often used in combination with acupoint stimulation to achieve better therapeutic effects. Meanwhile, acupuncture and moxibustion therapy has demonstrated good efficacy and safety in the prevention and treatment of PSCI. Multiple clinical studies suggest that electroacupuncture therapy can improve cognitive impairment in patients with PSCI and enhance their quality of life. Furthermore, electroacupuncture therapy can also provide targeted treatment for patients through syndrome differentiation and treatment, compensating for the limitations of Western medicine drug therapy.
This study aims to investigate the evolution patterns of syndromes in post-stroke cognitive impairment (PSCI). Simultaneously, through the standardization of multidimensional and multimodal data related to PSCI patients, we will conduct a multicenter, large-sample clinical randomized controlled trial of electroacupuncture intervention for PSCI using a multimodal artificial intelligence big data model. The goal is to establish a characteristic technology for the diagnosis and treatment of PSCI in traditional Chinese medicine (TCM) that is suitable for promotion, and to establish clinical diagnosis and treatment pathways and standard specifications for diseases where TCM has advantages. This will facilitate the establishment of an efficacy evaluation system for PSCI based on TCM syndrome diagnosis and evolution patterns, realize a precise diagnosis and treatment model combining traditional Chinese and Western medicine for PSCI, and improve patients' overall efficacy and quality of life.
- Conditions
- Post-Stroke Cognitive Impairment (PSCI)
- Being tested
- Acupuncture
- Keywords
- Stroke, PSCI, Post-stroke cognitive impairment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called Electroacupuncture
Electroacupuncture group: After local routine disinfection.Select the main acupoints of bilateral frontoparietal line (MS2), Tianzhu (BL10), Fengchi (GB20), blood supply, parietal midline (MS5), and parietal midline (MS8). Connect the wires of the electroacupuncture instrument to the same side of the bilateral frontoparietal line(MS2) and Tianzhu acupoint (BL10), and perform head electroacupuncture treatment on both sides with a pair on each side.There are two groups of electroacupuncture, with a continuous frequency of 100Hz, and each electroacupuncture stimulation lasts for 30 minutes. After enrollment, treatment will be conducted 5 times a week for 8 weeks.
AcupunctureOther
Also called Sham electroacupuncture
Sham electroacupuncture group: After local routine disinfection. Choose the same acupoints as the electroacupuncture group, but use a specially designed electroacupuncture instrument that cannot output current, with only indicator lights or parameter displays when in use.
| Study group | Role | What they receive |
|---|---|---|
| Sham electroacupuncture group | Sham comparator | Treatment of electroacupuncture device without output current based on ordinary acupuncture and moxibustion Receives: Other: Acupuncture |
| Electroacupuncture group | Experimental | Treatment with electro-acupuncture device on the basis of ordinary needling Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Test Battery(NTB)
Measured: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Montreal Cognitive Assessment
Measured: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Mini-Mental State Examination
Measured: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Secondary outcomes (8)
Modified Barthel Index
Measured: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Hamilton Depression Scale(HAMD)
<7 indicates no, 7-17 indicates possible, 17-24 indicates certain,>24 indicates severe depression. The lowest score is 0, and the highest score is 46. The higher the score, the more severe the patient's depression.
Measured: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Electroencephalogram(EEG)
Evaluate the quantitative electroencephalogram parameters alpha wave, beta wave, delta wave, and theta wave absolute power, as well as the (delta+theta)/(alpha+beta) ratio (DTABR) and delta/alpha power ratio (DAR), and analyze the correlation between various parameters and cognitive function.
Measured: Pre-treatment, 8th week post-treatment
Near-infrared spectroscopy
Measured: Pre-treatment, 8th week post-treatment
Modified Rankin Scale(mRS)
The scoring criteria are 0-5 points, with 0 being completely asymptomatic and 5 being severely disabled.
Measured: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Pittsburgh sleep quality index(PSQI)
It consists of seven dimensions: subjective sleep quality, falling asleep time, sleep duration, sleep disturbances, use of hypnotic drugs, daytime functional disorders, and sleep efficiency. Each dimension scores 0-3 points, with a minimum score of 0 and a maximum score of 21 points. The higher the score, the more severe the sleep problem. The total score of the seven dimensions is the PSQI score.
Measured: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Magnetic Resonance Imaging
Measured: Pre-treatment, 8th week post-treatment
Short Form 12 Health Survey(SF-12)
This scale covers eight aspects: physical function, physical role, pain, general health, mental health, social function, emotional role, and psychological health. The overall score range is 0-100 points, with higher scores indicating better health conditions.
Measured: Week 8 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start5 Oct 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Stroke Cognitive Impairment (PSCI)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijie Ma
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, The Third Affiliated hospital of Zhejiang Chinese Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang Provincial People's Hospital
- Responsible party
- Sponsor-investigator, Ruijie Ma, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Ruijie Ma, Principal investigator, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208019
- Sponsor's protocol ID
- 2025C02200
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When all research plans are completed and all participants have completed the clinical study, data access can be opened.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Key Technology of Acupoint Modulation-based Brain Electric Field Therapy for the Treatment of Post-stroke Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07208019
- Acronym / sponsor ID
- 2025C02200
- Conditions
- Post-Stroke Cognitive Impairment (PSCI)
- Keywords
- Stroke, PSCI, Post-stroke cognitive impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Ruijie MaUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, The Third Affiliated hospital of Zhejiang Chinese Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou Hospital of Traditional Chinese Medicine, Zhejiang Provincial People's Hospital
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 6 Oct 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.
Stroke is a global public health issue, and it has become a leading cause of death and disability in China. With the rapid aging of the Chinese population, its incidence rate is continuously rising. According to the "China Stroke Prevention and Treatment Report (2023)", on average, one person experiences a new or recurrent stroke every 10 seconds in China, and one person dies from stroke every 28 seconds. Currently, there are 4 million new stroke cases in China each year, with 12.42 million individuals aged 40 and above currently suffering from stroke, and the affected population is showing a trend of younger onset. Among survivors, approximately 75% suffer from residual disabilities, and 40% have severe disabilities. Consequently, patient families will experience significant economic losses and physical and psychological pain.
Post-Stroke Cognitive Impairment (PSCI) is a common complication of stroke, where patients develop cognitive impairment within six months after the stroke event that meets the diagnostic criteria for cognitive impairment. PSCI is defined as a clinical phenomenon secondary to stroke events, with cognitive decline as its core characteristic. Such impairments encompass cognitive dysfunction caused by various stroke types and are one of the main determinants of functional dependency in post-stroke survivors. The prevalence of PSCI within six months is approximately 30% to 50%, with 10% progressing to dementia. Additionally, PSCI patients face a high risk of death, with up to 61% dying within five years. Countries worldwide have launched targeted guidelines, calling for increased attention and investment in this major complication. However, current treatments for PSCI are still limited to secondary prevention measures for stroke and drugs for treating Alzheimer's disease-like conditions, all lacking high-level clinical evidence. Therefore, effective treatments are urgently needed to improve patient outcomes.
PSCI is a dynamically evolving process, with individual differences in its occurrence time, influencing factors, clinical manifestations, and recovery prognosis. The unique diagnostic system of traditional Chinese medicine may assist in analyzing the disease progression of PSCI. The study of the patterns of syndrome evolution can help explain and provide reference for treatment. Currently, there are no specific drugs for treating PSCI, and relevant drug treatments lack high-level evidence. In recent years, with the development of imaging, artificial intelligence, and electromagnetic physics, non-pharmacological therapies have gradually become one of the research hotspots in the field of PSCI. It is worth noting that non-invasive brain stimulation, represented by transcranial electrical stimulation, is a therapy that directly acts on the brain lesions of PSCI and is often used in combination with acupoint stimulation to achieve better therapeutic effects. Meanwhile, acupuncture and moxibustion therapy has demonstrated good efficacy and safety in the prevention and treatment of PSCI. Multiple clinical studies suggest that electroacupuncture therapy can improve cognitive impairment in patients with PSCI and enhance their quality of life. Furthermore, electroacupuncture therapy can also provide targeted treatment for patients through syndrome differentiation and treatment, compensating for the limitations of Western medicine drug therapy.
This study aims to investigate the evolution patterns of syndromes in post-stroke cognitive impairment (PSCI). Simultaneously, through the standardization of multidimensional and multimodal data related to PSCI patients, we will conduct a multicenter, large-sample clinical randomized controlled trial of electroacupuncture intervention for PSCI using a multimodal artificial intelligence big data model. The goal is to establish a characteristic technology for the diagnosis and treatment of PSCI in traditional Chinese medicine (TCM) that is suitable for promotion, and to establish clinical diagnosis and treatment pathways and standard specifications for diseases where TCM has advantages. This will facilitate the establishment of an efficacy evaluation system for PSCI based on TCM syndrome diagnosis and evolution patterns, realize a precise diagnosis and treatment model combining traditional Chinese and Western medicine for PSCI, and improve patients' overall efficacy and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham electroacupuncture group | Sham comparator | Other: AcupunctureTreatment of electroacupuncture device without output current based on ordinary acupuncture and moxibustion |
| Electroacupuncture group | Experimental | Other: AcupunctureTreatment with electro-acupuncture device on the basis of ordinary needling |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- According to the Western diagnostic criteria for vascular cognitive impairment outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Vascular Cognitive Impairment (2024 Edition)" developed by the Vascular Cognitive Impairment Branch of the Chinese Stroke Society.
- Meets the traditional Chinese medicine diagnostic criteria for vascular cognitive impairment in the "Guidelines for Traditional Chinese Medicine Diagnosis and Treatment of Vascular Mild Cognitive Impairment (2024)";
- The Mini Mental State Examination (MMSE) score ranges from 12-24, while the Montreal Cognitive Assessment (MoCA) score is below 24; Having cognitive impairment but not reaching the level of severe dementia; The National Institutes of Health Stroke Scale (NIHSS) score is ≤ 8 points; The Early Dementia Screening Scale (Ascertain Dementia 8, AD-8) score is less than 2 points;
- Age between 35-80 years old;
- Have basic communication skills, with Mandarin as the main language (communication language is sufficient), and have at least one stable caregiver;
Key exclusion criteria (6 listed)
- Merge serious primary chronic diseases such as heart, liver, kidney, endocrine system, and hematopoietic system, as well as severe cardiovascular and cerebrovascular diseases;
- Skin diseases or scar constitution such as herpes and ulceration are easy to appear on the body surface, which is not suitable for acupuncture and moxibustion treatment;
- Not suitable for repetitive MRI examinations, such as claustrophobia, arterial aneurysm embolization, etc;
- Patients with cognitive impairment or other severe neurological or mental disorders prior to the onset of this illness, and unstable control;
- Patients identified by other clinical trial personnel as unsuitable for this study;
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 |
|---|---|---|
| AcupunctureAlso: ElectroacupunctureElectroacupuncture group: After local routine disinfection.Select the main acupoints of bilateral frontoparietal line (MS2), Tianzhu (BL10), Fengchi (GB20), blood supply, parietal midline (MS5), and parietal midline (MS8). Connect the wires of the electroacupuncture instrument to the same side of the bilateral frontoparietal line(MS2) and Tianzhu acupoint (BL10), and perform head electroacupuncture treatment on both sides with a pair on each side.There are two groups of electroacupuncture, with a continuous frequency of 100Hz, and each electroacupuncture stimulation lasts for 30 minutes. After enrollment, treatment will be conducted 5 times a week for 8 weeks. | Other | Electroacupuncture group |
| AcupunctureAlso: Sham electroacupunctureSham electroacupuncture group: After local routine disinfection. Choose the same acupoints as the electroacupuncture group, but use a specially designed electroacupuncture instrument that cannot output current, with only indicator lights or parameter displays when in use. | Other | Sham electroacupuncture group |
Primary outcome
Neuropsychological Test Battery(NTB)
Time frame: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Montreal Cognitive Assessment
Time frame: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Mini-Mental State Examination
Time frame: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
8 secondary outcomes
Modified Barthel Index
Time frame: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Hamilton Depression Scale(HAMD)
Time frame: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Electroencephalogram(EEG)
Time frame: Pre-treatment, 8th week post-treatment
Near-infrared spectroscopy
Time frame: Pre-treatment, 8th week post-treatment
Modified Rankin Scale(mRS)
Time frame: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Pittsburgh sleep quality index(PSQI)
Time frame: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment
Magnetic Resonance Imaging
Time frame: Pre-treatment, 8th week post-treatment
Short Form 12 Health Survey(SF-12)
Time frame: Week 8 after treatment
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 17 Dec 2025.
- Individual participant dataSharing planned: Undecided. When all research plans are completed and all participants have completed the clinical study, data access can be opened.
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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.
Ruijie Ma principal investigator
The Third Affiliated hospital of Zhejiang Chinese Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Post-Stroke Cognitive Impairment (PSCI), run by Ruijie Ma at 5 sites 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 6 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 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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 Bowen Chen (+86 13967988987, cbwwjj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Test Battery(NTB) (time frame: Week 0 before treatment, Week 12 after treatment, Week 24 after treatment). 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?
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 17 Dec 2025.