Safty and Efficacy of MCI Network Guided TMS for Early Alzheimer's Disease: A Randomized, Double-blind Trial
NCT ID: NCT07138677
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-07-20
2025-12-30
Brief Summary
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Detailed Description
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For each participant, the investigators will compute their persoanlized dorsal prefrontal targets by using their own resting-state functional MRI data and a predefined MCI network. They will then be randomly assigned to receive real or sham rTMS treatment for two weeks. The sham stimulations will be delivered by a sham coil. All the experiment procedures are the same between groups except the coil.
With a statistical power of 0.8, an effect size of 0.96, a significance level of 0.05, and a 5% expected dropout rate, the final sample size is 20 participants per group. In this double-blind study, patients and clinical raters are masked to the allocated conditions. Only one investigator responsible for group allocation has access to the randomization list.
Each participant will be treated for 14 days by rTMS. Before the rTMS treatment, a trained investigator will perform a series of cognitive assessments and neuropsychological tests. The ADAS-Cog is the primary outcome. Other tasks and questionnaires include cognition (including MoCA, MMSE, DS, Stroop test, BNT-30, VFT, CDT, JLOT. Form H, HVOT), memory (CAVLT, LMT), emotion (HAMA-17,HAMD-14), behavioral and psychological symptoms (NPI), and treatment tolerability. All the tests will be conducted within two days. The participants undergo a multi-modal MRI scan and an electroencephalogram (EEG) examination.
The participants also undergo the ADAS-cog, a battery of neuropsychological tests, multi-modal MRI, and EEG examinations. participants will be instructed to focus their answers on the past 14 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MCI real group
Stimulation delivered by a real coil through MagStim Rapid2 and guided by BrainSight navigation system.
transcranial magnetic stimulation
Neuronavigated Theta-Burst Transcranial Magnetic Stimulation
MCI sham group
Stimulation delivered by a sham coil through MagStim Rapid2 and guided by BrainSight navigation system.
transcranial magnetic stimulation
Neuronavigated Theta-Burst Transcranial Magnetic Stimulation
Interventions
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transcranial magnetic stimulation
Neuronavigated Theta-Burst Transcranial Magnetic Stimulation
Eligibility Criteria
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Inclusion Criteria
2. MMSE score 18-28.
3. CDR score 0.5-1.
4. On stable treatment with IAChE or memantine for at least 6 months.
5. Literate in Han Chinese.
Exclusion Criteria
2. Depression or other psychiatric disorders.
3. History of head injury, stroke, epilepsy or other neurologic disease.
4. Organic brain defects on T1 or T2 images.
5. History of unexplained loss of consciousness.
6. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, or any implanted medical device that is incompatible with MRI.
7. Family history of medication refractory epilepsy.
8. History of substance abuse within the last 6 months.
45 Years
85 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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WANG KAI
Director of medical psychological department, Anhui Medical University
Locations
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Anhui Medical University
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AHMU-NetTMS-eAD
Identifier Type: -
Identifier Source: org_study_id
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