Safty and Efficacy of MCI Network Guided TMS for Early Alzheimer's Disease: A Randomized, Double-blind Trial
SENS-eAD
The Safty and Efficacy of Mild Cognitiive Impairment Network Guided Transcranial Magnetic Stimulations for Patients With Early Alzheimer's Disease (SENS-eAD): A Randomized, Double-blind Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
Estimate the safty and efficacy of personalized network neuronavigated transcranial magnetic stimulations in early Alzheimer's disease patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedStudy Start
First participant enrolled
July 20, 2025
CompletedFirst Posted
Study publicly available on registry
August 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedSeptember 15, 2025
September 1, 2025
5 months
April 30, 2025
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog)
The changes in Alzheimers Disease Assessment Scale Cognitive section (ADAS-Cog) will constitute the major research outcome measure used to assess response to transcranial magnetic stimulation (TMS). The ADAS-COG scale tests orientation, language, structure, use of ideas, immediate recall of words and word re-recognition, and consists of 11 questions out of a possible 70 points, with the higher the score the more cognitively impaired.
Baseline and 2 weeks
Secondary Outcomes (12)
Mini Mental State Examination (MMSE)
Baseline and 2 weeks
Montreal Cognitive Assessment (MoCA)
Baseline and 2 weeks
Digital Span Test; Forward and Backward (DST)
Baseline and 2 weeks
Hamilton Depression Scale (HAMD)
Baseline and 2 weeks
Hamilton Anxiety Scale (HAMA)
Baseline and 2 weeks
- +7 more secondary outcomes
Study Arms (2)
MCI real group
EXPERIMENTALStimulation delivered by a real coil through MagStim Rapid2 and guided by BrainSight navigation system.
MCI sham group
SHAM COMPARATORStimulation delivered by a sham coil through MagStim Rapid2 and guided by BrainSight navigation system.
Interventions
Neuronavigated Theta-Burst Transcranial Magnetic Stimulation
Eligibility Criteria
You may qualify if:
- Subject diagnosed as either mild cognitive impairment due to AD or mild AD dementia based on National Institute on Aging-Alzheimer's Association criteria.
- MMSE score 18-28.
- CDR score 0.5-1.
- On stable treatment with IAChE or memantine for at least 6 months.
- Literate in Han Chinese.
You may not qualify if:
- Recevied rTMS treatment in the past 3 months.
- Depression or other psychiatric disorders.
- History of head injury, stroke, epilepsy or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of unexplained loss of consciousness.
- Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, or any implanted medical device that is incompatible with MRI.
- Family history of medication refractory epilepsy.
- History of substance abuse within the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anhui Medical University
Hefei, Anhui, 230000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of medical psychological department, Anhui Medical University
Study Record Dates
First Submitted
April 30, 2025
First Posted
August 24, 2025
Study Start
July 20, 2025
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
September 15, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share