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

Primary Purpose

Mild to Moderate Alzheimer Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TMS
sham coil stimulation
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Alzheimer Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TMS group

Sham group

Arm Description

Transcranial magnetic stimulation for four weeks

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. )

Outcomes

Primary Outcome Measures

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
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
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
the short term change of COWAT score in TMS group
the short term change of COWAT(controlled oral word association) score in TMS group
the short term change of Stroop score in TMS group
the short term change of Stroop score in TMS group
the short term change of TMT score in TMS group
the short term change of TMT(trail-making test) score in TMS group
the short term change of RVP score in TMS group
the short term change of RVP(raid visual information processing) score in TMS group
the short term change of SWM score in TMS group
the short term change of SWM (spatial working memory) score in TMS group
the short term change of PRM score in TMS group
the short term change of PRM(pattern recognition memory) score in TMS group

Secondary Outcome Measures

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
the long term change of K-MoCA score in TMS group
the long term change of K-MoCA (Korean version of Montreal cognitive assessment) score in TMS group
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
the long term change of COWAT score in TMS group
the long term change of COWAT(controlled oral word association) score in TMS group
the long term change of Stroop score in TMS group
the long term change of Stroop score in TMS group
the long term change of TMT score in TMS group
the long term change of TMT(trail-making test) score in TMS group
the long term change of RVP score in TMS group
the long term change of RVP(raid visual information processing) score in TMS group
the long term change of SWM score in TMS group
the long term change of SWM (spatial working memory) score in TMS group
the long term change of PRM score in TMS
the long term change of PRM(pattern recognition memory) score in TMS group
the change of ADL(activity of daily life) in TMS group
the score change of S-IADL(Seoul-Instrumental activities of daily life)
the short term change of mood (depression) in TMS group
the score change of GDS(geriatric depression scale) short form
the long term change of mood (depression) in TMS group
the score change of GDS(geriatric depression scale) short form
the change of brain function in TMS group
the qualititve change of resting functional MRI
the change of brain structure in TMS group
the change of FA (fractional anisotropy) value in DTI (diffusion tensor imaging) analysis
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)
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)
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)
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)
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
the comparison of short term change of Stroop test score between TMS group and sham group
the score change of Stroop test score
the comparison of short term change of TMT between TMS group and sham group
the score change of TMT (trail making test)
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
the comparison of short term change of SWM between TMS group and sham group
the score change of SWM (spatial working memory) score
the comparison of short term change of PRM between TMS group and sham group
the score change of PRM(pattern recognition memory) score
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)
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)
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)
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)
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
the comparison of long term change of stroop test score between TMS group and sham group
the score change of stroop test score
the comparison of long term change of TMT score between TMS group and sham group
the score change of TMT(trail making test)
the comparison of long term change of RVP score between TMS group and sham group
the score change of RVP(raid visual information processing)
the comparison of long term change of SWM score between TMS group and sham group
the score change of SWM (spatial working memory) score
the comparison of long term change of cognitive function between TMS group and sham group
the score change of PRM(pattern recognition memory) score
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
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
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 )
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 )
the comparison of change of resting fMRI between TMS group and sham group
the qualititve change of resting fMRI
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

Full Information

First Posted
January 22, 2020
Last Updated
February 5, 2020
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04260724
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 7, 2020 (Anticipated)
Primary Completion Date
February 7, 2021 (Anticipated)
Study Completion Date
February 7, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMS group
Arm Type
Active Comparator
Arm Description
Transcranial magnetic stimulation for four weeks
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
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. )
Intervention Type
Device
Intervention Name(s)
TMS
Intervention Description
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
Intervention Name(s)
sham coil stimulation
Intervention Description
no stimulation Although the sound from device during stimulation is similar, no stimulation is applied.
Primary Outcome Measure Information:
Title
the short term change of K-MMSE score in TMS group
Description
the short term change of K-MMSE (Korean version of mini mental status exam) score in TMS group
Time Frame
4 weeks
Title
the short term change of K-MoCA score in TMS group
Description
the short term change of K-MoCA (Korean version of Montreal cognitive assessment) score in TMS group
Time Frame
4 weeks
Title
the short term change of ADAS-Cog score in TMS group
Description
the short term change of ADAS-Cog(the Alzheimer's disease assessment scale-cognitive subscale) score in TMS group
Time Frame
4 weeks
Title
the short term change of COWAT score in TMS group
Description
the short term change of COWAT(controlled oral word association) score in TMS group
Time Frame
4 weeks
Title
the short term change of Stroop score in TMS group
Description
the short term change of Stroop score in TMS group
Time Frame
4 weeks
Title
the short term change of TMT score in TMS group
Description
the short term change of TMT(trail-making test) score in TMS group
Time Frame
4 weeks
Title
the short term change of RVP score in TMS group
Description
the short term change of RVP(raid visual information processing) score in TMS group
Time Frame
4 weeks
Title
the short term change of SWM score in TMS group
Description
the short term change of SWM (spatial working memory) score in TMS group
Time Frame
4 weeks
Title
the short term change of PRM score in TMS group
Description
the short term change of PRM(pattern recognition memory) score in TMS group
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
the long term change of K-MMSE score in TMS group
Description
the long term change of K-MMSE (Korean version of mini mental status exam) score in TMS group
Time Frame
8 weeks
Title
the long term change of K-MoCA score in TMS group
Description
the long term change of K-MoCA (Korean version of Montreal cognitive assessment) score in TMS group
Time Frame
8 weeks
Title
the long term change of ADAS-Cog score in TMS group
Description
the long term change of ADAS-Cog(the Alzheimer's disease assessment scale-cognitive subscale) score in TMS group
Time Frame
8 weeks
Title
the long term change of COWAT score in TMS group
Description
the long term change of COWAT(controlled oral word association) score in TMS group
Time Frame
8 weeks
Title
the long term change of Stroop score in TMS group
Description
the long term change of Stroop score in TMS group
Time Frame
8 weeks
Title
the long term change of TMT score in TMS group
Description
the long term change of TMT(trail-making test) score in TMS group
Time Frame
8 weeks
Title
the long term change of RVP score in TMS group
Description
the long term change of RVP(raid visual information processing) score in TMS group
Time Frame
8 weeks
Title
the long term change of SWM score in TMS group
Description
the long term change of SWM (spatial working memory) score in TMS group
Time Frame
8 weeks
Title
the long term change of PRM score in TMS
Description
the long term change of PRM(pattern recognition memory) score in TMS group
Time Frame
8 weeks
Title
the change of ADL(activity of daily life) in TMS group
Description
the score change of S-IADL(Seoul-Instrumental activities of daily life)
Time Frame
4 weeks
Title
the short term change of mood (depression) in TMS group
Description
the score change of GDS(geriatric depression scale) short form
Time Frame
4 weeks
Title
the long term change of mood (depression) in TMS group
Description
the score change of GDS(geriatric depression scale) short form
Time Frame
8 weeks
Title
the change of brain function in TMS group
Description
the qualititve change of resting functional MRI
Time Frame
4 weeks
Title
the change of brain structure in TMS group
Description
the change of FA (fractional anisotropy) value in DTI (diffusion tensor imaging) analysis
Time Frame
4 weeks
Title
the comparison of short term change of K-MMSE score between TMS group and sham group
Description
the score change of K-MMSE (Korean version of mini mental status exam)
Time Frame
4 weeks
Title
the comparison of short term change of K-MoCA score between TMS group and sham group
Description
the score change of K-MoCA (Korean version of Montreal cognitive assessment)
Time Frame
4 weeks
Title
the comparison of short term change of CDR-SOB between TMS group and sham group
Description
the score change of CDR-SOB (Clinical dementia rating-sum of boxes)
Time Frame
4 weeks
Title
the comparison of short term change of ADAS-Cog between TMS group and sham group
Description
the score change of ADAS-Cog ( the Alzheimer's disease assessment scale-cognitive subscale)
Time Frame
4 weeks
Title
the comparison of short term change of COWAT score between TMS group and sham group
Description
the score change of COWAT(controlled oral word association) score
Time Frame
4 weeks
Title
the comparison of short term change of Stroop test score between TMS group and sham group
Description
the score change of Stroop test score
Time Frame
4 weeks
Title
the comparison of short term change of TMT between TMS group and sham group
Description
the score change of TMT (trail making test)
Time Frame
4 weeks
Title
the comparison of short term change of RVP score between TMS group and sham group
Description
the score change of RVP(raid visual information processing) score
Time Frame
4 weeks
Title
the comparison of short term change of SWM between TMS group and sham group
Description
the score change of SWM (spatial working memory) score
Time Frame
4 weeks
Title
the comparison of short term change of PRM between TMS group and sham group
Description
the score change of PRM(pattern recognition memory) score
Time Frame
4 weeks
Title
the comparison of change of K-MMSE between TMS group and sham group
Description
the score change of K-MMSE(Korean version of mini mental status exam)
Time Frame
8 weeks
Title
the comparison of long term change of K-MoCA between TMS group and sham group
Description
the score change of K-MoCA (Korean version of Montreal cognitive assessment)
Time Frame
8 weeks
Title
the comparison of long term change of CDR-SOB between TMS group and sham group
Description
the score change of CDR-SOB(Clinical dementia rating-sum of boxes)
Time Frame
8 weeks
Title
the comparison of long term change of ADAS-Cog between TMS group and sham group
Description
the score change of ADAS-Cog ( the Alzheimer's disease assessment scale-cognitive subscale)
Time Frame
8 weeks
Title
the comparison of long term change of COWAT score between TMS group and sham group
Description
the score change of COWAT(controlled oral word association) score
Time Frame
8 weeks
Title
the comparison of long term change of stroop test score between TMS group and sham group
Description
the score change of stroop test score
Time Frame
8 weeks
Title
the comparison of long term change of TMT score between TMS group and sham group
Description
the score change of TMT(trail making test)
Time Frame
8 weeks
Title
the comparison of long term change of RVP score between TMS group and sham group
Description
the score change of RVP(raid visual information processing)
Time Frame
8 weeks
Title
the comparison of long term change of SWM score between TMS group and sham group
Description
the score change of SWM (spatial working memory) score
Time Frame
8 weeks
Title
the comparison of long term change of cognitive function between TMS group and sham group
Description
the score change of PRM(pattern recognition memory) score
Time Frame
8 weeks
Title
the comparison of short term change of mood (depression) between TMS group and sham group
Description
the score change of GDS (geriatric depression scale) short form
Time Frame
4 weeks
Title
the comparison of long term change of mood (depression) between TMS group and sham group
Description
the score change of GDS (geriatric depression scale) short form
Time Frame
8 weeks
Title
the comparison of short term change of ADL between TMS group and sham group
Description
the score change of S-IADL(Seoul instrumental activity of daily life )
Time Frame
4 weeks
Title
the comparison of long term change of ADL between TMS group and sham group
Description
the score change of S-IADL(Seoul instrumental activity of daily life )
Time Frame
8 weeks
Title
the comparison of change of resting fMRI between TMS group and sham group
Description
the qualititve change of resting fMRI
Time Frame
4 weeks
Title
the comparison of change of FA value between TMS group and sham group
Description
the change of FA(fractional anisotropy) value in DTI(diffusion tensor imaging) analysis
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Hee Jung, MD PhD
Phone
82-10-6755-5462
Email
neophilia1618@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Young Lee
Phone
82-2-3410-3788
Email
l2sy82@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk L Na, MD PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sun Young Lee
Phone
+82-2-3410-3788
Email
l2sy82@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No
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Results Reference
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Study on the Effect of Transcranial Magnetic Stimulation in Mild to Moderate Alzheimer's Disease

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