The Underlying Neural Mechanism of TMS in Improving the Imbalance of "Microbiota-brain-gut Axis" in Alzheimer 's Disease Population

April 4, 2026 updated by: Second Affiliated Hospital of Nanchang University

What is this study about? This study focuses on Alzheimer's Disease (AD), a common neurodegenerative disease that affects memory, thinking, and daily life. We aim to explore whether a non-invasive treatment called Repetitive Transcranial Magnetic Stimulation (rTMS) can improve AD symptoms by regulating the "gut-brain-intestine axis" - a connection between gut bacteria, the brain, and the intestines.

Who can participate?

  • **AD patients**: Aged 50-80, diagnosed with mild to moderate AD (MMSE score 18-27, MoCA score 10-26), with stable condition for at least 6 months, and able to cooperate with tests and treatment.
  • **Healthy controls**: Aged 50-80, with normal cognitive function (MMSE ≥28, MoCA ≥27), no AD family history, and matched in age and gender with AD patients.

Those with epilepsy, severe mental illness, recent use of antibiotics/probiotics, or inability to complete MRI scans are not eligible.

What will participants experience?

  • **AD patients**: Will be randomly divided into two groups. Both groups will receive 4 weeks of treatment (5 days/week) with a helmet-like device. One group gets real rTMS (safe magnetic stimulation to the brain), and the other gets sham stimulation (no effective magnetic field, but same sound/feel).
  • **Healthy controls**: No treatment, but will complete the same tests as AD patients.
  • **Tests during the study**: Cognitive assessments (memory, thinking skills via questionnaires), stool/blood sample collection (to check gut bacteria and body markers), and MRI scans (to look at brain structure/function) at baseline, 1 month, 3 months, 6 months, and 1 year.

What are the potential benefits?

  • Free rTMS treatment (for AD patients), free MRI scans (valued at 700 RMB), and a 200 RMB subsidy.
  • Free health checks (gut bacteria analysis, metabolic tests) and cognitive evaluations to understand personal health status.
  • Contribution to developing new AD treatments that may help future patients.

Is it safe? rTMS is a clinically proven safe technique. Possible mild side effects (headache, scalp irritation) usually go away on their own. Sample collection (stool/blood) and MRI scans are non-invasive or minimally invasive. A professional team will monitor participants throughout to handle any issues.

For healthcare providers This is a multicenter, randomized, double-blind sham-controlled study (200 AD patients, 200 healthy controls). The primary goal is to explore rTMS's mechanism via the gut-brain-intestine axis, with MoCA score changes (6 months post-treatment) as the main outcome. It integrates multi-omics and neuroimaging data to provide evidence for AD's non-drug treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Dementia Patients: Conformed to internationally recognized diagnostic criteria for dementia (e.g., DSM-5, NINCDS-ADRDA)
  • Diagnosed through clinical evaluation, neuropsychological scale assessments, and relevant examinations
  • Aged ≥50 years and residing in Nanchang, Jiangxi
  • With dementia-negative family history, no severe psychiatric or neurological disorders
  • No history of major systemic diseases.

Exclusion Criteria:

  • Unable to cooperate with all required examinations, intervention procedures, and sample collection during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients undergoing treatment
Procedure: TMS
For the repetitive transcranial magnetic stimulation (rTMS) intervention, the dorsolateral prefrontal cortex (DLPFC) is selected as the stimulation target, with a stimulation frequency of 10 Hz; the intervention consists of 20 stimulation trains per day, 5 days per week, using a coil with a diameter of 9 cm, at an intensity of 80% of the motor threshold (minimum single-pulse intensity: 50 μV); each stimulation train lasts for 10 seconds, with an interval of 25 seconds between trains, and 20 trains per day totaling 2000 pulses. The treatment is administered once daily, five times a week, for 4 consecutive weeks, resulting in a total of 20 to 30 sessions, and the traditional "5-centimeter" method is adopted for localizing the DLPFC stimulation target.
No Intervention: No treatment
The sham DLPFC-rTMS group will receive stimulation via a single helmet equipped with a sham coil, which is designed to induce similar noise and scalp sensations under the same parameters as the active stimulation group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MoCA score
Time Frame: Pre-intervention, Periprocedural, and Post-intervention at 1/3/6/12 months
The Montreal Cognitive Assessment (MoCA) is a widely used tool for screening mild cognitive impairment (MCI), and its scoring reflects an individual's performance in cognitive domains such as attention, memory, and language. The total score is 30; a score of ≥26 is generally considered normal, 18-25 indicates mild cognitive impairment, and ≤17 may indicate moderate to severe impairment. Higher scores in the intervention group indicate better intervention effects.
Pre-intervention, Periprocedural, and Post-intervention at 1/3/6/12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 21, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

September 30, 2030

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 4, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMS82460341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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