NCT04260724

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2022

Completed
Last Updated

February 7, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

January 22, 2020

Last Update Submit

February 5, 2020

Conditions

Mild to Moderate Alzheimer Disease

Outcome Measures

Primary Outcomes (9)

  • 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

    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

Secondary Outcomes (40)

  • the long term change of K-MMSE score in TMS group

    8 weeks

  • the long term change of K-MoCA score in TMS group

    8 weeks

  • the long term change of ADAS-Cog score in TMS group

    8 weeks

  • the long term change of COWAT score in TMS group

    8 weeks

  • the long term change of Stroop score in TMS group

    8 weeks

  • +35 more secondary outcomes

Study Arms (2)

TMS group

ACTIVE COMPARATOR

Transcranial magnetic stimulation for four weeks

Device: TMS

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. )

Device: sham coil stimulation

Interventions

TMSDEVICE

* 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 )

TMS group
sham coil stimulationDEVICE

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

Sham group

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (11)

  • 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.

    PMID: 30996057BACKGROUND

  • 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.

    PMID: 17101829BACKGROUND

  • 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.

    PMID: 20574108BACKGROUND

  • 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.

    PMID: 19049544BACKGROUND

  • 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.

    PMID: 25170153BACKGROUND

  • 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.

    PMID: 29277405BACKGROUND

  • 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.

    PMID: 17565358BACKGROUND

  • 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.

    PMID: 24844687BACKGROUND

  • 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.

    PMID: 4003102BACKGROUND

  • 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.

    PMID: 30140737RESULT

  • 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.

    PMID: 38709534DERIVED

Study Officials

  • Duk L Na, MD PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Hee Jung, MD PhD

CONTACT

82-10-6755-5462neophilia1618@gmail.com

Sun Young Lee

CONTACT

82-2-3410-3788l2sy82@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2020

First Posted

February 7, 2020

Study Start

February 7, 2020

Primary Completion

February 7, 2021

Study Completion

February 7, 2022

Last Updated

February 7, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)