Clinical trial NCT04260724: Study on the Effect of Transcranial Magnetic Stimulation in Mild to Moderate Alzheimer's Disease
Official title: Prospective, Randomized, Evaluator-blind, Single Center Study on the Effect of Transcranial Magnetic Stimulation in Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild to Moderate Alzheimer Disease
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 32
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: the short term change of K-MMSE score in TMS group
timeFrame: 4 weeks
measure: the short term change of K-MoCA score in TMS group
timeFrame: 4 weeks
measure: the short term change of ADAS-Cog score in TMS group
timeFrame: 4 weeks
measure: the short term change of COWAT score in TMS group
timeFrame: 4 weeks
measure: the short term change of Stroop score in TMS group
timeFrame: 4 weeks
measure: the short term change of TMT score in TMS group
timeFrame: 4 weeks
measure: the short term change of RVP score in TMS group
timeFrame: 4 weeks
measure: the short term change of SWM score in TMS group
timeFrame: 4 weeks
measure: the short term change of PRM score in TMS group
timeFrame: 4 weeks
Secondary outcomes:
measure: the long term change of K-MMSE score in TMS group
timeFrame: 8 weeks
measure: the long term change of K-MoCA score in TMS group
timeFrame: 8 weeks
measure: the long term change of ADAS-Cog score in TMS group
timeFrame: 8 weeks
measure: the long term change of COWAT score in TMS group
timeFrame: 8 weeks
measure: the long term change of Stroop score in TMS group
timeFrame: 8 weeks
measure: the long term change of TMT score in TMS group
timeFrame: 8 weeks
measure: the long term change of RVP score in TMS group
timeFrame: 8 weeks
measure: the long term change of SWM score in TMS group
timeFrame: 8 weeks
measure: the long term change of PRM score in TMS
timeFrame: 8 weeks
measure: the change of ADL(activity of daily life) in TMS group
timeFrame: 4 weeks
measure: the short term change of mood (depression) in TMS group
timeFrame: 4 weeks
measure: the long term change of mood (depression) in TMS group
timeFrame: 8 weeks
measure: the change of brain function in TMS group
timeFrame: 4 weeks
measure: the change of brain structure in TMS group
timeFrame: 4 weeks
measure: the comparison of short term change of K-MMSE score between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of short term change of K-MoCA score between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of short term change of CDR-SOB between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of short term change of ADAS-Cog between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of short term change of COWAT score between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of short term change of Stroop test score between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of short term change of TMT between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of short term change of RVP score between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of short term change of SWM between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of short term change of PRM between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of change of K-MMSE between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of long term change of K-MoCA between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of long term change of CDR-SOB between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of long term change of ADAS-Cog between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of long term change of COWAT score between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of long term change of stroop test score between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of long term change of TMT score between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of long term change of RVP score between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of long term change of SWM score between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of long term change of cognitive function between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of short term change of mood (depression) between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of long term change of mood (depression) between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of short term change of ADL between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of long term change of ADL between TMS group and sham group
timeFrame: 8 weeks
measure: the comparison of change of resting fMRI between TMS group and sham group
timeFrame: 4 weeks
measure: the comparison of change of FA value between TMS group and sham group
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Duk L Na, MD PhD
role: PRINCIPAL_INVESTIGATOR
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