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Effects of deep transcranial magnetic stimulation on cognitive function, intestinal flora, serum metabolomics and neuroimaging in people with mild cognitive impairment: A Cohort Study

Effects of deep transcranial magnetic stimulation on cognitive function, intestinal flora, serum metabolomics and neuroimaging in people with mild cognitive impairment: A Cohort Study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075489
Enrollment
Unknown
Registered
2023-09-06
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild cognitive impairment

Interventions

aMCI treatment group:deep transcranial magnetic stimulation for 4 weeks
aMCI control group:live as usual for 4weeks

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 79 Years

Inclusion criteria

Inclusion criteria: aMCI population (50 cases) : 1) Age 55-79 years old; 2) Able to understand instructions and communicate with the experimenter normally; 3) It meets the aMCI scientific research diagnostic criteria proposed by Peterson in 2004, that is, it meets the aMCI diagnostic criteria: a. Subjective memory impairment provided by myself and confirmed by an informed person; b. Objective memory impairment was present. The auditory word learning test was used in this study, and the delayed memory score was lower than 1.5SD under age correction (N5=4 score for 55-59 year olds; 60-69 years old population, N5=3 score; 70-79 years old, N5=2 points); c. Basic cognitive function was retained. This study adopted mini-mental state examination (MMSE) to reach the normal age-adjusted standard (illiterates > 17 points, primary schools > 20 points, secondary schools and above > 24 points); d. Basically intact daily Activities. This study adopted Activities of daily living (ADL) < 23 points; e. does not meet the diagnostic criteria for any type of dementia; 4) No other mental disorders; 5) There were no depressive symptoms, and The Geriatric Depression Scale (GDS-15) was used in this study to evaluate and screen, and the score was < A score of 5 is considered as no depressive symptoms. 6) clinical dementia rating scale (CDR) =0.5 Healthy control (50 cases) : 1) Age 55-79 years old; 2) Able to understand instructions and communicate with the experimenter normally; 3) Normal cognitive function; 4) No depressive symptoms (GDS 30 items<15 points).

Exclusion criteria

Exclusion criteria: 1) There are definite mental and nervous system disorders (such as schizophrenia, alcohol dependence, substance abuse, cerebral hemorrhage, massive cerebral infarction, transient ischemic attack, epilepsy, Parkinson's disease, etc.); 2) History of craniocerebral trauma, coma, general anesthesia in the past 6 months; 3) Can not cooperate with the cognitive test; 4) Patients with dTMS treatment contrainidations (including patients or users of implanted devices such as cardiac pacemakers, implantable defibrillators and neurostimulators, patients with a history of epilepsy, acute cerebral hemorrhage, acute infectious diseases, patients wearing electronic products such as insulin pumps, holters, etc., and patients with body implants; Patients with malignant tumors; Pregnant women and inexpressive children; An open wound; Vascular embolism; Hypoleukocyte, etc.) 5) Use of drugs that affect cognitive function (including cholinesterase inhibitors, memantine hydrochloride, cabalatin, benzodiazepines and antipsychotics, etc.) within 3 months; 7) Other unstable physical diseases that may affect cognitive function include: uncontrolled arrhythmia, hypertension, glycemic disease, acute pulmonary embolism, deep vein thrombosis, recent or unstable fractures, inflammation or traumatic joint injury. 8) Metabolic diseases, obesity, cirrhosis, fatty liver, inflammatory bowel disease, irritable bowel syndrome, asthma, special dietary habits. Take dairy products (yogurt, etc.) or antibiotics within 1 month prior to sampling.

Design outcomes

Primary

MeasureTime frame
Montreal Cognitive Assessment Scale(MoCA);Auditory vocabulary learning test(AVLT);Trail Making Test(TMT);clock draw test (CDT);Verbal fluency test(VFT);Digit Span Test( DST);function connection(FC);Fractional anisotropy(FA);

Countries

China

Contacts

Public ContactYanqing Tang

The First Affiliated Hospital of China Medical University

yanqingtang@163.com+86 159 4001 0069

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026