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
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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UNKNOWN
NA
32 participants
INTERVENTIONAL
2020-02-07
2022-02-07
Brief Summary
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The investigators also compare the change of cognitition, mood (depression), ADL, and brain structural and functional MRI between TMS group and sham coil group.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TMS group
Transcranial magnetic stimulation for four weeks
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 )
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. )
sham coil stimulation
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 )
sham coil stimulation
no stimulation Although the sound from device during stimulation is similar, no stimulation is applied.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
90 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Duk Lyul Na
Professor
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SMC_2019-04-010-004
Identifier Type: -
Identifier Source: org_study_id
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