Study on the Effect of Transcranial Magnetic Stimulation in Mild to Moderate Alzheimer's Disease

Samsung Medical Center

Status: Unknown

Conditions: Mild to Moderate Alzheimer Disease

Treatments: Device: TMS; Device: sham coil stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04260724

SMC_2019-04-010-004

Details and patient eligibility

About

The investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI before and after 4-week transcranial magnetic stimulation in patients with mild to moderate Alzheimer's disease.

The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.

Full description

Each 16 patients will be allocated to TMS group and sham coil group. Before TMS/sham coil stimulation, the investigators will take fMRI of each patient, and figure out which focus has strongest connectivity to hippocampus among lateral parietal regions of the brain. The investigators will fix the TSM transduced and apply accurate TMS stimulation to the focus using personalized frames. The investigators will make the frame using 3D printing technology.

After 4 week- TMS stimulation, the investigators will compare cognitition, mood (depression), ADL, and brain structural and functional MRI beween baseline and after intervention. The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.

Enrollment: 32 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients who visited memory clinic of Samsung Medical Center
• aged 55 ~ 90
• diagnosed as probable Alzheimer dementia according to NIA-AA guideline 2011, or MCI patiens with amyloid PET positivity
• below -1SD in SVLTdelayed recall test and RCFT delayed recall test
• K-MMSE >=18
• no epileptic discharge in EEG
• no history of epilepsy
• no arrhythmia or MI in ECG
• can read and write Korean (literate)
• volunteer and agree to the registration

Exclusion criteria

• no other neurologic deficit which can cause dementia except for Alzheimer's disease
• paitient who has severe cerebral white matter hyperintensities. (deep white matter >=2.5cm and caps or band >=1.0 cm)
• patients with severe medical disease including caner and ishemic heart disease
• claustrophobia or allergic to contrast of MRI
• medical deviced which is not removable (e.g pacemaker, cochlear implantation, dental prosthesis)
• history of brain surgery, and intervension or surgery of intra/extracranial artery(e.g. carotid artery stent insertion, CEA)
• patient with dyspnea during resting
• history of loss of consciousness for more than 1 hour except for general anesthesia
• patients who cannot read written material because of poor visual acuity
• patients who cannot communicate because of severe hearing difficulty
• history of ototoxicity medication or exposure severe noises
• determined as inapropriate to participate clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

TMS group

Active Comparator group

Description:

Transcranial magnetic stimulation for four weeks

Treatment:

Device: TMS

Sham group

Sham Comparator group

Description:

sham coil stimulation for four weeks (Although the sound of sham coil is the same to that of real TMS during intervension, no stimulation is applied. )

Treatment:

Device: sham coil stimulation