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Parkinson DiseasePhase 4NCT06710574

Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving RBD with Parkinson's Disease

A Phase 4 study testing PD-RBD and iRBD in people with Parkinson Disease and Movement Disorders, run by Beijing Friendship Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Rapid eye movement sleep behavior disorder (RBD) is important non-movement feature, and also the important risk factor of Parkinson's disease (PD). In our previous work, we found that the movement features and RBD of PD patients improved after taking probiotics. Read more about this study

Who is it for?
Ages 40 to 85 yearsHealthy volunteers can take part
What is being tested?
PD-RBD and iRBD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
1 Sep 2022to 30 Jun 2025
Phase
Phase 4
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 40 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age between 40 and 80 years, both males and females
  • Patients with idiopathic Parkinson's disease, meeting the MDS clinical diagnostic criteria for Parkinson's disease (2015)
  • Modified Hoehn and Yahr stage of Parkinson's disease ≤ stage 3
  • No dementia, with a Mini-Mental State Examination (MMSE) score > 24
  • No depression or anxiety, as indicated by Hamilton Depression Scale score < 9 and Anxiety Scale score < 14
  • Rapid Eye Movement Sleep Behavior Disorder (RBD) screening questionnaire score > 5, diagnosed with RBD based on polysomnography results, and exclusion of obstructive sleep apnea
Show all 23Show fewer
  • Stable condition of Parkinson's disease motor symptoms and RBD symptoms in the month prior to enrollment, with no adjustments to Parkinson's disease medications in the month prior to enrollment
  • Discontinuation of benzodiazepines such as clonazepam and melatonin in the month prior to enrollment
  • No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed
  • Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.
  • Age between 40 and 80 years, both males and females
  • Rapid Eye Movement Sleep Behavior Disorder (RBD) screening questionnaire score > 5, diagnosed with RBD based on polysomnography results, and exclusion of obstructive sleep apnea or restless legs syndrome
  • No dementia, with a Mini-Mental State Examination (MMSE) score > 24
  • No depression or anxiety, as indicated by Hamilton Depression Scale score < 9 and Anxiety Scale score < 14
  • Discontinuation of benzodiazepines such as clonazepam and melatonin in the month prior to enrollment
  • No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed
  • Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.
  • Age between 40 and 80 years, age and gender matched with the above two groups of patients
  • Rapid Eye Movement Sleep Behavior Disorder screening questionnaire score ≤ 5, exclusion of RBD or obstructive sleep apnea based on polysomnography results
  • No dementia, with a Mini-Mental State Examination (MMSE) score > 24.
  • No depression or anxiety, as indicated by Hamilton Depression Scale score < 9 and Anxiety Scale score < 14
  • No severe constipation, not meeting the diagnostic criteria for Rome III chronic constipation; No use of probiotics, prebiotics (including lactulose), or antibiotics for the two months prior to enrollment, if used, a two-month washout period should be observed
  • Understanding and willingness to comply with the study protocol, agreeing to participate, and signing the informed consent form.

Who cannot join

  • PD-RBD exclusion criteria:
  • Parkinsonism plus syndrome and secondary parkinsonism such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or any other non-primary parkinsonism
  • Taking any probiotics or prebiotics (including lactulose) or antibiotics within 2 months before enrollment
  • Adjustment of Parkinson's disease medication within 1 month before enrollment; In group 1 month before taking clonazepam and benzodiazepines medicine melatonin, etc.
  • With the following diseases such as Alzheimer's disease, malignant tumor, spinal cord lesions, epilepsy, autonomic nerve disease (urinary retention, urinary incontinence or orthostatic hypotension, vertical drop in blood pressure in five minutes more than 30/15 MMHG), etc.; New onset of cerebrovascular disease or severe sequelae of cerebrovascular disease within 3 months, affecting the assessment
  • Patients with anxiety or depression and taking medication
Show all 34Show fewer
  • Serious cardiovascular diseases (such as the American heart association heart function class for Ⅲ - Ⅳ of congestive heart failure, the 6 month history of myocardial infarction, etc.)
  • Severe liver and kidney dysfunction, cereal third transaminase, aspertate aminotransferase, total bilirubin is higher than the upper limit of normal value of 1. 5 times; Serum creatinine is higher than the upper limit of normal value 1. 5 times
  • Pregnant and lactating women or pregnant women aged 40-60 years with positive HCG;
  • Known to be allergic to Bifidobacterium triple viable capsules, Bacillus licheniformis, or their excipients
  • Has a history of history of drug abuse or alcohol dependence
  • Were enrolled in another clinical trial at enrollment
  • Refusal to participate in the study or inability to cooperate with the study investigator; The researchers judgment for doesn't fit into the group of patients.
  • PD motor symptoms and parkinsonism were included in the PD-RBD group; "Parkinsonism plus syndrome and secondary parkinsonism, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or any other non-primary Parkinson's disease;"
  • Into the group 2 months before taking any probiotics and prebiotics (including lactulose) or antibiotics
  • Adjustment of Parkinson's disease medication within 1 month before enrollment; In group 1 month before taking clonazepam and benzodiazepines medicine melatonin, etc.
  • With the following diseases, including but not limited to obstructive sleep apnea syndrome, Alzheimer disease, malignant tumor, spinal cord lesions, epilepsy, autonomic nerve disease (urinary retention, urinary incontinence or orthostatic hypotension, vertical drop in blood pressure in five minutes more than 30/15 MMHG), etc.; 3 month new cerebrovascular disease or severe cerebrovascular disease sequela, impact assessment;
  • Patients with severe anxiety or depression or under drug treatment;
  • Severe cardiovascular diseases (such as congestive heart failure with American Heart Association functional class Ⅲ-Ⅳ, history of myocardial infarction within 6 months, etc.);
  • Severe liver and kidney dysfunction, cereal third transaminase, aspertate aminotransferase, total bilirubin is higher than the upper limit of normal value of 1. 5 times; The serum creatinine was higher than the upper limit of the normal range. 5 times;
  • Pregnant and lactating women or pregnant women aged 40-60 years with positive HCG;
  • Known to be allergic to Bifidobacterium triple viable capsules, Bacillus licheniformis, or their excipients;
  • With a history of drug abuse or alcohol dependence
  • Were enrolled in another clinical trial at enrollment;
  • Refused into groups, and can cooperate with researchers; Patients who were judged by the investigator to be ineligible for enrollment.
  • Healthy subjects exclusion criteria:
  • Patients with Parkinson's disease motor symptoms and met the diagnosis of parkinsonism were included in PD-RBD group; "Parkinsonism plus syndrome and secondary parkinsonism, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, dementia with Lewy bodies, vascular parkinsonism, post-encephalitis parkinsonism, or any other non-primary Parkinson's disease;" 2) taking any probiotics or prebiotics (including lactulose) or antibiotics within 2 months before enrollment; 1 month before the 3) into the group of Parkinson's disease medication adjustment; Benzodiazepines such as clonazepam and melatonin were taken within 1 month before enrollment. 4) combined with the following diseases, including but not limited to obstructive sleep apnea syndrome, Alzheimer's disease, malignant tumors, spinal cord lesions, epilepsy, autonomic disorders (urinary retention, urinary incontinence or orthostatic hypotension, blood pressure drop more than 30/15 MMHG after 5 minutes of standing), etc.; New onset of cerebrovascular disease or severe sequelae of cerebrovascular disease within 3 months, affecting the assessment
  • Patients with severe anxiety or depression or under drug treatment;
  • Severe cardiovascular diseases (such as congestive heart failure with American Heart Association functional class Ⅲ-Ⅳ, history of myocardial infarction within 6 months, etc.)
  • Severe liver and kidney dysfunction, cereal third transaminase, aspertate aminotransferase, total bilirubin is higher than the upper limit of normal value of 1. 5 times; The serum creatinine was higher than the upper limit of the normal range. 5 times
  • Pregnant and lactating women or pregnant women aged 40-60 years with positive HCG; 9) known to the bifidobacterium triple viable capsules, bacillus licheniformis, or its accessories, and other allergies;
  • With a history of drug abuse or alcohol dependence
  • Were enrolled in another clinical trial at enrollment;
  • Refused into groups, and can cooperate with researchers; The researchers judgment for doesn't fit into the group of patients.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Houzhen Tuo Principal Investigator, PhD contact

+8613683628005

tuohouzhen@ccmu.edu.cn

China1 site, 1 recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050

    Houzhen Tuo Principal Investigator, PhD, +8613683628005, tuohouzhen@ccmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Multimodal Image Technologies Investigate the Role and Mechanism of Probiotics in Improving Rapid Eye Movement Behavior Disorder with Parkinson's Disease

Rapid eye movement sleep behavior disorder (RBD) is important non-movement feature, and also the important risk factor of Parkinson's disease (PD). In our previous work, we found that the movement features and RBD of PD patients improved after taking probiotics. The later was not reported before and the mechanism not clear. To investigate its role and mechanism, we plan to enroll patients of PD-RBD, idiopathic RBD, and healthy control, collect data of multimodal image technology before and after probiotic treatment，including resting state functional MRI，1H-MRS，123I-MIBG; analyze these data with clinical features, including UPDRS -III score, RBD-HK score , as well as the bacteria abundance and level of glutamate，GABA in blood and stool. Then, construct PD mouse model by fecal transplantation of PD patient, give or not give mouse probiotics treatment, and detect the level of glutamate, GABA, and so on, as well as α-synuclein of each brain area of each group, to explore the role and mechanism of probiotics in improving RBD and movement disorder of PD.

Read the detailed description

The primary objectives of this study are to explore the effects and mechanisms of probiotic intervention on improving REM sleep behavior disorder (RBD) in patients with Parkinson's disease (PD) from both clinical and animal experimental levels. The study aims to elucidate the scientific hypothesis that "probiotic intervention improves RBD in PD patients through a neuroendocrine mechanism," providing a theoretical basis for the mechanism by which probiotic intervention alleviates RBD symptoms in PD patients.

Research Content:

Establishing imaging detection technical processes and parameters for RBD.Collecting pre- and post-probiotic treatment imaging parameters and comparing them with RBD improvement to explore the mechanism by which probiotics improve PD patient RBD.Detecting fecal microbiota abundance and blood and fecal metabolite concentrations to discuss the biochemical mechanism by which probiotics improve PD motor symptoms and RBD.

Research Methods:

Patient Recruitment:

Enrolling PD-RBD, iRBD, and healthy control subjects, with specific inclusion and exclusion criteria based on clinical diagnosis and symptomatology.

Clinical Assessments and Tests:

Utilizing standardized scales such as RBDSQ, RBD-HK, UPDRS-III, and Hoehn-Yahr staging for symptom evaluation. Conducting polysomnography (PSG) for RBD diagnosis and exclusion of other sleep disorders.

Multimodal Imaging Data Collection:

Employing 3.0T MRI for high-precision anatomical imaging, resting-state functional MRI (rs-fMRI), and proton magnetic resonance spectroscopy (1H-MRS) for glutamate, GABA, and other metabolites in specific brain regions.

Performing 123I-MIBG cardiac scintigraphy to assess cardiac sympathetic nerve function.

Laboratory Tests:

Measuring concentrations of glutamate, GABA, acetylcholine, and other metabolites in blood and fecal samples. Assessing fecal microbiota abundance through 16S rRNA gene sequencing.

Research Methods:

Patient Recruitment:

Enrolling PD-RBD, iRBD, and healthy control subjects, with specific inclusion and exclusion criteria based on clinical diagnosis and symptomatology.

Clinical Assessments and Tests:

Utilizing standardized scales such as RBDSQ, RBD-HK, UPDRS-III, and Hoehn-Yahr staging for symptom evaluation.

Conducting polysomnography (PSG) for RBD diagnosis and exclusion of other sleep disorders.

Multimodal Imaging Data Collection:

Employing 3.0T MRI for high-precision anatomical imaging, resting-state functional MRI (rs-fMRI), and proton magnetic resonance spectroscopy (1H-MRS) for glutamate, GABA, and other metabolites in specific brain regions.

Performing 123I-MIBG cardiac scintigraphy to assess cardiac sympathetic nerve function.

Laboratory Tests:

Measuring concentrations of glutamate, GABA, acetylcholine, and other metabolites in blood and fecal samples.

Assessing fecal microbiota abundance through 16S rRNA gene sequencing.

Data Analysis:

Correlating imaging data, clinical symptoms, microbiota abundance, and metabolite concentrations to explore the mechanisms of probiotic intervention in PD and RBD.

Being tested
PD-RBD, iRBD
Keywords
Probiotic, Parkinson's disease, Rapid Eye Movement Sleep Behavior Disorder, Multimodel Magnetic Resonance Imaging
Medical subject headings
Parkinson Disease, Movement Disorders, REM Sleep Behavior Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD-RBDDrug

    Bifidobacterium triple viable capsule (Bifico Capsule, Shanghai Shangyao Xinyi Pharmaceutical Factory Co., LTD.) 420mg, two times a day, 4 capsules each time; At the same time give the bacillus licheniformis living bacterium capsule (whole bowel capsule, northeast pharmaceutical) 0.5 g, three times a day, two at a time, keep the original anti Parkinson's drugs

  • iRBDDrug

    Bifidobacterium triple viable capsule (Bifico Capsule, Shanghai Shangyao Xinyi Pharmaceutical Factory Co., LTD.) 420mg, two times a day, 4 capsules each time; At the same time give the bacillus licheniformis living bacterium capsule (whole bowel capsule, northeast pharmaceutical) 0.5 g, three times a day, two at a time.

Study groups in NCT06710574
Study groupRoleWhat they receive
idiopathic Rapid Eye Movement sleep behavior disorder (iRBD)ExperimentalBifidobacterium triple viable capsule (Bifico Capsule, Shanghai Shangyao Xinyi Pharmaceutical Factory Co., LTD.) 420mg, two times a day, 4 capsules each time; At the same time give the bacillus licheniformis living bacterium capsule (whole bowel capsule, northeast pharmaceutical) 0.5 g, three times a day, two at a time
Receives: Drug: iRBD
Parkinson's disease without Rapid Eye Movement sleep behavior disorderNo interventionPD subjects without RBD matched for age and sex to PD with RBD, iRBD and healthy control subjects
Healthy controlNo interventionHealthy subjects without RBD matched for age and sex to PD and iRBD subjects
Parkinson's disease with Rapid Eye Movement sleep behavior disorder groupExperimentalBifidobacterium triple viable capsule (Bifico Capsule, Shanghai Shangyao Xinyi Pharmaceutical Factory Co., LTD.) 420mg, two times a day, 4 capsules each time; At the same time give the bacillus licheniformis living bacterium capsule (whole bowel capsule, northeast pharmaceutical) 0.5 g, three times a day, two at a time, keep the original anti Parkinson's drugs
Receives: Drug: PD-RBD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Magnetic resonance imaging changes of brain structure and function

    Measured: 12 weeks

  2. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale(MDS-UPDRS)

    Measured: 12 weeks

  3. The abundance of gut microbiota

    Measured: 12 weeks

Secondary outcomes (12)

  1. Patient assessment of constipation symptom

    Measured: 12 weeks

  2. Epworth sleepiness score

    Measured: 12 weeks

  3. Hoehn-Yahr

    Measured: 12 weeks

  4. RBD Questionnaire-Hong Kong

    Measured: 12 weeks

  5. Rapid-eye-movement Sleep Behavior Disorder Screening Questionnaire

    Measured: 12 weeks

  6. Pittsburgh Sleep Quality Index

    Measured: 12 weeks

  7. Cleveland Clinic Score

    Measured: 12 weeks

  8. Functional constipation diagnostic standard scale

    Measured: 12 weeks

  9. Glutamate (blood)

    Measured: 12 weeks

  10. Glutamate (feces)

    Measured: 12 weeks

  11. N-acetylaspartate(blood)

    Measured: 12 weeks

  12. N-acetylaspartate(feces)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2024
  2. Study start1 Sep 2022
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06710574
Sponsor's protocol ID
2022-P2-172
Status last verified
Oct 2024
First submitted
26 Nov 2024
Last updated
2 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Valencia Garcia S, Libourel PA, Lazarus M, Grassi D, Luppi PH, Fort P. Genetic inactivation of glutamate neurons in the rat sublaterodorsal tegmental nucleus recapitulates REM sleep behaviour disorder. Brain. 2017 Feb;140(2):414-428. doi: 10.1093/brain/aww310. Epub 2016 Dec 21.

    PubMed 28007991

  • Henrich MT, Geibl FF, Lee B, Chiu WH, Koprich JB, Brotchie JM, Timmermann L, Decher N, Matschke LA, Oertel WH. A53T-alpha-synuclein overexpression in murine locus coeruleus induces Parkinson's disease-like pathology in neurons and glia. Acta Neuropathol Commun. 2018 May 10;6(1):39. doi: 10.1186/s40478-018-0541-1.

    PubMed 29747690

  • Knudsen K, Fedorova TD, Hansen AK, Sommerauer M, Otto M, Svendsen KB, Nahimi A, Stokholm MG, Pavese N, Beier CP, Brooks DJ, Borghammer P. In-vivo staging of pathology in REM sleep behaviour disorder: a multimodality imaging case-control study. Lancet Neurol. 2018 Jul;17(7):618-628. doi: 10.1016/S1474-4422(18)30162-5. Epub 2018 Jun 1.

    PubMed 29866443

  • Pyatigorskaya N, Gaurav R, Arnaldi D, Leu-Semenescu S, Yahia-Cherif L, Valabregue R, Vidailhet M, Arnulf I, Lehericy S. Magnetic Resonance Imaging Biomarkers to Assess Substantia Nigra Damage in Idiopathic Rapid Eye Movement Sleep Behavior Disorder. Sleep. 2017 Nov 1;40(11). doi: 10.1093/sleep/zsx149.

    PubMed 28958075

  • Mayer G, Bitterlich M, Kuwert T, Ritt P, Stefan H. Ictal SPECT in patients with rapid eye movement sleep behaviour disorder. Brain. 2015 May;138(Pt 5):1263-70. doi: 10.1093/brain/awv042. Epub 2015 Mar 1.

    PubMed 25732183

  • Rahayel S, Postuma RB, Montplaisir J, Bedetti C, Brambati S, Carrier J, Monchi O, Bourgouin PA, Gaubert M, Gagnon JF. Abnormal Gray Matter Shape, Thickness, and Volume in the Motor Cortico-Subcortical Loop in Idiopathic Rapid Eye Movement Sleep Behavior Disorder: Association with Clinical and Motor Features. Cereb Cortex. 2018 Feb 1;28(2):658-671. doi: 10.1093/cercor/bhx137.

    PubMed 28591814

  • De Marzi R, Seppi K, Hogl B, Muller C, Scherfler C, Stefani A, Iranzo A, Tolosa E, Santamaria J, Gizewski E, Schocke M, Skalla E, Kremser C, Poewe W. Loss of dorsolateral nigral hyperintensity on 3.0 tesla susceptibility-weighted imaging in idiopathic rapid eye movement sleep behavior disorder. Ann Neurol. 2016 Jun;79(6):1026-30. doi: 10.1002/ana.24646. Epub 2016 Apr 22.

    PubMed 27016314

  • Rolinski M, Griffanti L, Piccini P, Roussakis AA, Szewczyk-Krolikowski K, Menke RA, Quinnell T, Zaiwalla Z, Klein JC, Mackay CE, Hu MT. Basal ganglia dysfunction in idiopathic REM sleep behaviour disorder parallels that in early Parkinson's disease. Brain. 2016 Aug;139(Pt 8):2224-34. doi: 10.1093/brain/aww124. Epub 2016 Jun 12.

    PubMed 27297241

  • Luppi PH. Jouvet's animal model of RBD, clinical RBD, and their relationships to REM sleep mechanisms. Sleep Med. 2018 Sep;49:28-30. doi: 10.1016/j.sleep.2018.05.026. Epub 2018 Jun 6.

    PubMed 30172630

  • Alam R, Abdolmaleky HM, Zhou JR. Microbiome, inflammation, epigenetic alterations, and mental diseases. Am J Med Genet B Neuropsychiatr Genet. 2017 Sep;174(6):651-660. doi: 10.1002/ajmg.b.32567. Epub 2017 Jul 10.

    PubMed 28691768

  • Fang X. Potential role of gut microbiota and tissue barriers in Parkinson's disease and amyotrophic lateral sclerosis. Int J Neurosci. 2016 Sep;126(9):771-6. doi: 10.3109/00207454.2015.1096271. Epub 2015 Oct 16.

    PubMed 26381230

  • Stolzenberg E, Berry D, Yang D, Lee EY, Kroemer A, Kaufman S, Wong GCL, Oppenheim JJ, Sen S, Fishbein T, Bax A, Harris B, Barbut D, Zasloff MA. A Role for Neuronal Alpha-Synuclein in Gastrointestinal Immunity. J Innate Immun. 2017;9(5):456-463. doi: 10.1159/000477990. Epub 2017 Jun 27.

    PubMed 28651250

  • Sampson TR, Debelius JW, Thron T, Janssen S, Shastri GG, Ilhan ZE, Challis C, Schretter CE, Rocha S, Gradinaru V, Chesselet MF, Keshavarzian A, Shannon KM, Krajmalnik-Brown R, Wittung-Stafshede P, Knight R, Mazmanian SK. Gut Microbiota Regulate Motor Deficits and Neuroinflammation in a Model of Parkinson's Disease. Cell. 2016 Dec 1;167(6):1469-1480.e12. doi: 10.1016/j.cell.2016.11.018.

    PubMed 27912057

  • Scheperjans F, Aho V, Pereira PA, Koskinen K, Paulin L, Pekkonen E, Haapaniemi E, Kaakkola S, Eerola-Rautio J, Pohja M, Kinnunen E, Murros K, Auvinen P. Gut microbiota are related to Parkinson's disease and clinical phenotype. Mov Disord. 2015 Mar;30(3):350-8. doi: 10.1002/mds.26069. Epub 2014 Dec 5.

    PubMed 25476529

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PD-RBD and iRBD in people with Parkinson Disease and Movement Disorders, run by Beijing Friendship Hospital 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 23 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Houzhen Tuo Principal Investigator, PhD (+8613683628005, tuohouzhen@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Magnetic resonance imaging changes of brain structure and function (time frame: 12 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 NCT06710574, 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 2 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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