Safty and Efficacy of MCI Network Guided TMS for Early Alzheimer's Disease: A Randomized, Double-blind Trial (SENS-eAD)

Anhui Medical University

Status: Enrolling

Conditions: Alzheimer's Disease; Individualized Navigation; Transcranial Magnetic Stimulation

Treatments: Other: transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07138677

AHMU-NetTMS-eAD

Details and patient eligibility

About

Estimate the safty and efficacy of personalized network neuronavigated transcranial magnetic stimulations in early Alzheimer's disease patients

Full description

All patients undergo a series of medical assessments that include physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a series of cognitive assessments and rTMS treatments at the First Affiliated Hospital of AnHui medical university. Stratified block randomization will be used to assign participants to different intervention groups. Stratification is based on Mini-Mental State Examination (MMSE) scores (<24 vs. ≥24), and randomization will be conducted using variable block sizes of 4 or 6.

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject diagnosed as either mild cognitive impairment due to AD or mild AD dementia based on National Institute on Aging-Alzheimer's Association 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

1. Recevied rTMS treatment in the past 3 months.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

MCI real group

Experimental group

Description:

Stimulation delivered by a real coil through MagStim Rapid2 and guided by BrainSight navigation system.

Treatment:

Other: transcranial magnetic stimulation

MCI sham group

Sham Comparator group

Description:

Stimulation delivered by a sham coil through MagStim Rapid2 and guided by BrainSight navigation system.

Treatment:

Other: transcranial magnetic stimulation