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fMRI-guided personalized TMS intervention for early Alzheimer's disease: a multicenter, double-blind, randomized, controlled trial on efficacy and mechanisms

fMRI-guided personalized TMS intervention for early Alzheimer's disease: a multicenter, double-blind, randomized, controlled trial on efficacy and mechanisms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115525
Enrollment
Unknown
Registered
2025-12-28
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Alzheimers disease

Interventions

EF-guided group:Employing the iTBS paradigm, individualised superficial cortical stimulation targets were calculated using GCA-fMRI. The resting motor threshold was set at 100%. Stimulation duration w
Non-precision group:Using the iTBS paradigm, stimulation targets were selected at random sites within the IPL. Each pulse lasted 2 seconds, with an 8-second inter-pulse interval. Each session comprise

Sponsors

Affiliated Hospital of Hangzhou Normal University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Aged 50-85 years, meeting the 2024 AD diagnostic criteria established by the National Institute on Aging and the Alzheimer's Association. 2.Clinical Dementia Rating (CDR) score of 0.5 to 1. 3.Positive for core AD Class 1 biomarkers. 4.Able to cooperate with multimodal MRI examination. 5.Able to cooperate with TMS treatment. 6.Patient provides informed consent and signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Contraindications for TMS intervention and magnetic resonance imaging (e.g., cardiac pacemaker). 2.Comorbid with other severe diseases such as malignant tumors. 3.Cognitive impairment due to other various causes or severe mental illness (24-item HAMD score >35, 14-item HAMA score >29), unable to maintain a sitting position and cooperate with rehabilitation assessment and treatment. 4.History of metal implant surgery. 5.History of epileptic seizures/epilepsy/taking anti-epileptic drugs; Pregnancy. 6.History of cranial surgery. 7.Presence of severe cardiopulmonary dysfunction, extreme debilitation, or other medically unstable conditions.

Design outcomes

Primary

MeasureTime frame
ADAS-cog14 Score;

Secondary

MeasureTime frame
Multimodal MRI metrics;

Countries

China

Contacts

Public ContactWangjinghua

Affiliated Hospital of Hangzhou Normal University

231032407@qq.com+86 571 88358358

Outcome results

None listed

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