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

NCT ID: NCT04260724

Last Updated: 2020-02-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2022-02-07

Brief Summary

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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

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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.

Conditions

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Mild to Moderate Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TMS group

Transcranial magnetic stimulation for four weeks

Group Type ACTIVE_COMPARATOR

TMS

Intervention Type DEVICE

* stimulation intensity : motor threshold 100%
* stimulation frequency : 1600 pulses for 20 minutes
* stimulation duration :for four weaks, 20 minutes/day, 5 days per week (Monday - Friday )

Sham group

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. )

Group Type SHAM_COMPARATOR

sham coil stimulation

Intervention Type DEVICE

no stimulation Although the sound from device during stimulation is similar, no stimulation is applied.

Interventions

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TMS

* stimulation intensity : motor threshold 100%
* stimulation frequency : 1600 pulses for 20 minutes
* stimulation duration :for four weaks, 20 minutes/day, 5 days per week (Monday - Friday )

Intervention Type DEVICE

sham coil stimulation

no stimulation Although the sound from device during stimulation is similar, no stimulation is applied.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Duk Lyul Na

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duk L Na, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Young Hee Jung, MD PhD

Role: CONTACT

82-10-6755-5462

Sun Young Lee

Role: CONTACT

82-2-3410-3788

Facility Contacts

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Sun Young Lee

Role: primary

+82-2-3410-3788

References

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Nilakantan AS, Mesulam MM, Weintraub S, Karp EL, VanHaerents S, Voss JL. Network-targeted stimulation engages neurobehavioral hallmarks of age-related memory decline. Neurology. 2019 May 14;92(20):e2349-e2354. doi: 10.1212/WNL.0000000000007502. Epub 2019 Apr 17.

Reference Type BACKGROUND
PMID: 30996057 (View on PubMed)

Cotelli M, Manenti R, Cappa SF, Geroldi C, Zanetti O, Rossini PM, Miniussi C. Effect of transcranial magnetic stimulation on action naming in patients with Alzheimer disease. Arch Neurol. 2006 Nov;63(11):1602-4. doi: 10.1001/archneur.63.11.1602.

Reference Type BACKGROUND
PMID: 17101829 (View on PubMed)

Cotelli M, Calabria M, Manenti R, Rosini S, Zanetti O, Cappa SF, Miniussi C. Improved language performance in Alzheimer disease following brain stimulation. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):794-7. doi: 10.1136/jnnp.2009.197848. Epub 2010 Jun 23.

Reference Type BACKGROUND
PMID: 20574108 (View on PubMed)

Cotelli M, Manenti R, Cappa SF, Zanetti O, Miniussi C. Transcranial magnetic stimulation improves naming in Alzheimer disease patients at different stages of cognitive decline. Eur J Neurol. 2008 Dec;15(12):1286-92. doi: 10.1111/j.1468-1331.2008.02202.x.

Reference Type BACKGROUND
PMID: 19049544 (View on PubMed)

Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900.

Reference Type BACKGROUND
PMID: 25170153 (View on PubMed)

Koch G, Bonni S, Pellicciari MC, Casula EP, Mancini M, Esposito R, Ponzo V, Picazio S, Di Lorenzo F, Serra L, Motta C, Maiella M, Marra C, Cercignani M, Martorana A, Caltagirone C, Bozzali M. Transcranial magnetic stimulation of the precuneus enhances memory and neural activity in prodromal Alzheimer's disease. Neuroimage. 2018 Apr 1;169:302-311. doi: 10.1016/j.neuroimage.2017.12.048. Epub 2017 Dec 19.

Reference Type BACKGROUND
PMID: 29277405 (View on PubMed)

Ridding MC, Rothwell JC. Is there a future for therapeutic use of transcranial magnetic stimulation? Nat Rev Neurosci. 2007 Jul;8(7):559-67. doi: 10.1038/nrn2169.

Reference Type BACKGROUND
PMID: 17565358 (View on PubMed)

Bondi MW, Edmonds EC, Jak AJ, Clark LR, Delano-Wood L, McDonald CR, Nation DA, Libon DJ, Au R, Galasko D, Salmon DP. Neuropsychological criteria for mild cognitive impairment improves diagnostic precision, biomarker associations, and progression rates. J Alzheimers Dis. 2014;42(1):275-89. doi: 10.3233/JAD-140276.

Reference Type BACKGROUND
PMID: 24844687 (View on PubMed)

Weissman MM, Myers JK, Tischler GL, Holzer CE 3rd, Leaf PJ, Orvaschel H, Brody JA. Psychiatric disorders (DSM-III) and cognitive impairment among the elderly in a U.S. urban community. Acta Psychiatr Scand. 1985 Apr;71(4):366-79. doi: 10.1111/j.1600-0447.1985.tb02536.x.

Reference Type BACKGROUND
PMID: 4003102 (View on PubMed)

Kim S, Nilakantan AS, Hermiller MS, Palumbo RT, VanHaerents S, Voss JL. Selective and coherent activity increases due to stimulation indicate functional distinctions between episodic memory networks. Sci Adv. 2018 Aug 22;4(8):eaar2768. doi: 10.1126/sciadv.aar2768. eCollection 2018 Aug.

Reference Type RESULT
PMID: 30140737 (View on PubMed)

Jung YH, Jang H, Park S, Kim HJ, Seo SW, Kim GB, Shon YM, Kim S, Na DL. Effectiveness of Personalized Hippocampal Network-Targeted Stimulation in Alzheimer Disease: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e249220. doi: 10.1001/jamanetworkopen.2024.9220.

Reference Type DERIVED
PMID: 38709534 (View on PubMed)

Other Identifiers

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SMC_2019-04-010-004

Identifier Type: -

Identifier Source: org_study_id

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