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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS group | Active Comparator | Transcranial magnetic stimulation for four weeks |
|
| Sham group | Sham Comparator | 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. ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| the short term change of K-MMSE score in TMS group | the short term change of K-MMSE (Korean version of mini mental status exam) score in TMS group | 4 weeks |
| the short term change of K-MoCA score in TMS group | the short term change of K-MoCA (Korean version of Montreal cognitive assessment) score in TMS group | 4 weeks |
| the short term change of ADAS-Cog score in TMS group | the short term change of ADAS-Cog(the Alzheimer's disease assessment scale-cognitive subscale) score in TMS group | 4 weeks |
| the short term change of COWAT score in TMS group | the short term change of COWAT(controlled oral word association) score in TMS group | 4 weeks |
| the short term change of Stroop score in TMS group | the short term change of Stroop score in TMS group | 4 weeks |
| the short term change of TMT score in TMS group | the short term change of TMT(trail-making test) score in TMS group | 4 weeks |
| the short term change of RVP score in TMS group | the short term change of RVP(raid visual information processing) score in TMS group | 4 weeks |
| the short term change of SWM score in TMS group |
| Measure | Description | Time Frame |
|---|---|---|
| the long term change of K-MMSE score in TMS group | the long term change of K-MMSE (Korean version of mini mental status exam) score in TMS group | 8 weeks |
| the long term change of K-MoCA score in TMS group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Hee Jung, MD PhD | Contact | 82-10-6755-5462 | neophilia1618@gmail.com | |
| Sun Young Lee | Contact | 82-2-3410-3788 | l2sy82@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Duk L Na, MD PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30996057 | Background | 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. | |
| 17101829 | Background | 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. |
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| sham coil stimulation | Device | no stimulation Although the sound from device during stimulation is similar, no stimulation is applied. |
|
the short term change of SWM (spatial working memory) score in TMS group |
| 4 weeks |
| the short term change of PRM score in TMS group | the short term change of PRM(pattern recognition memory) score in TMS group | 4 weeks |
the long term change of K-MoCA (Korean version of Montreal cognitive assessment) score in TMS group
| 8 weeks |
| the long term change of ADAS-Cog score in TMS group | the long term change of ADAS-Cog(the Alzheimer's disease assessment scale-cognitive subscale) score in TMS group | 8 weeks |
| the long term change of COWAT score in TMS group | the long term change of COWAT(controlled oral word association) score in TMS group | 8 weeks |
| the long term change of Stroop score in TMS group | the long term change of Stroop score in TMS group | 8 weeks |
| the long term change of TMT score in TMS group | the long term change of TMT(trail-making test) score in TMS group | 8 weeks |
| the long term change of RVP score in TMS group | the long term change of RVP(raid visual information processing) score in TMS group | 8 weeks |
| the long term change of SWM score in TMS group | the long term change of SWM (spatial working memory) score in TMS group | 8 weeks |
| the long term change of PRM score in TMS | the long term change of PRM(pattern recognition memory) score in TMS group | 8 weeks |
| the change of ADL(activity of daily life) in TMS group | the score change of S-IADL(Seoul-Instrumental activities of daily life) | 4 weeks |
| the short term change of mood (depression) in TMS group | the score change of GDS(geriatric depression scale) short form | 4 weeks |
| the long term change of mood (depression) in TMS group | the score change of GDS(geriatric depression scale) short form | 8 weeks |
| the change of brain function in TMS group | the qualititve change of resting functional MRI | 4 weeks |
| the change of brain structure in TMS group | the change of FA (fractional anisotropy) value in DTI (diffusion tensor imaging) analysis | 4 weeks |
| the comparison of short term change of K-MMSE score between TMS group and sham group | the score change of K-MMSE (Korean version of mini mental status exam) | 4 weeks |
| the comparison of short term change of K-MoCA score between TMS group and sham group | the score change of K-MoCA (Korean version of Montreal cognitive assessment) | 4 weeks |
| the comparison of short term change of CDR-SOB between TMS group and sham group | the score change of CDR-SOB (Clinical dementia rating-sum of boxes) | 4 weeks |
| the comparison of short term change of ADAS-Cog between TMS group and sham group | the score change of ADAS-Cog ( the Alzheimer's disease assessment scale-cognitive subscale) | 4 weeks |
| the comparison of short term change of COWAT score between TMS group and sham group | the score change of COWAT(controlled oral word association) score | 4 weeks |
| the comparison of short term change of Stroop test score between TMS group and sham group | the score change of Stroop test score | 4 weeks |
| the comparison of short term change of TMT between TMS group and sham group | the score change of TMT (trail making test) | 4 weeks |
| the comparison of short term change of RVP score between TMS group and sham group | the score change of RVP(raid visual information processing) score | 4 weeks |
| the comparison of short term change of SWM between TMS group and sham group | the score change of SWM (spatial working memory) score | 4 weeks |
| the comparison of short term change of PRM between TMS group and sham group | the score change of PRM(pattern recognition memory) score | 4 weeks |
| the comparison of change of K-MMSE between TMS group and sham group | the score change of K-MMSE(Korean version of mini mental status exam) | 8 weeks |
| the comparison of long term change of K-MoCA between TMS group and sham group | the score change of K-MoCA (Korean version of Montreal cognitive assessment) | 8 weeks |
| the comparison of long term change of CDR-SOB between TMS group and sham group | the score change of CDR-SOB(Clinical dementia rating-sum of boxes) | 8 weeks |
| the comparison of long term change of ADAS-Cog between TMS group and sham group | the score change of ADAS-Cog ( the Alzheimer's disease assessment scale-cognitive subscale) | 8 weeks |
| the comparison of long term change of COWAT score between TMS group and sham group | the score change of COWAT(controlled oral word association) score | 8 weeks |
| the comparison of long term change of stroop test score between TMS group and sham group | the score change of stroop test score | 8 weeks |
| the comparison of long term change of TMT score between TMS group and sham group | the score change of TMT(trail making test) | 8 weeks |
| the comparison of long term change of RVP score between TMS group and sham group | the score change of RVP(raid visual information processing) | 8 weeks |
| the comparison of long term change of SWM score between TMS group and sham group | the score change of SWM (spatial working memory) score | 8 weeks |
| the comparison of long term change of cognitive function between TMS group and sham group | the score change of PRM(pattern recognition memory) score | 8 weeks |
| the comparison of short term change of mood (depression) between TMS group and sham group | the score change of GDS (geriatric depression scale) short form | 4 weeks |
| the comparison of long term change of mood (depression) between TMS group and sham group | the score change of GDS (geriatric depression scale) short form | 8 weeks |
| the comparison of short term change of ADL between TMS group and sham group | the score change of S-IADL(Seoul instrumental activity of daily life ) | 4 weeks |
| the comparison of long term change of ADL between TMS group and sham group | the score change of S-IADL(Seoul instrumental activity of daily life ) | 8 weeks |
| the comparison of change of resting fMRI between TMS group and sham group | the qualititve change of resting fMRI | 4 weeks |
| the comparison of change of FA value between TMS group and sham group | the change of FA(fractional anisotropy) value in DTI(diffusion tensor imaging) analysis | 4 weeks |
| 20574108 | Background | 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. |
| 19049544 | Background | 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. |
| 25170153 | Background | 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. |
| 29277405 | Background | 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. |
| 17565358 | Background | 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. |
| 24844687 | Background | 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. |
| 4003102 | Background | 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. |
| 30140737 | Result | 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. |
| 38709534 | Derived | 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. |