The Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
1 other identifier
interventional
27
1 country
1
Brief Summary
Objectives: The purpose of this study was to investigate the effects of high-frequency repetitive Transcranial Magnetic Stimulation (rTMS) in Alzheimer's Disease (AD). Methods: Twenty-seven AD patients aged ≥60 years were included in the study and divided into 3 groups (rTMS, Aerobic Exercise (AE) and control). All groups received pharmacological treatment. rTMS group (n=10) received 20 Hz rTMS treatment on bilateral dorsolateral prefrontal cortex, 5 days a week over 2 weeks, and AE group (n=10) received the moderate-intensity aerobic exercise for 50 min sessions, 5 days a week over 2 weeks. Control group (n=10) was only treated pharmacologically. Neuropsychiatric and behavioral status, cognition, balance, functional mobility, and quality of life, and functional brain changes were evaluated before and after the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Sep 2016
Shorter than P25 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 3, 2021
CompletedFirst Posted
Study publicly available on registry
November 1, 2021
CompletedNovember 1, 2021
October 1, 2021
8 months
August 3, 2021
October 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional Magnetic Resonance Imaging
Resting state networks and activation areas in the brain were evaluating with Functional Magnetic Resonance Imaging
4 weeks after baseline
Secondary Outcomes (7)
Neuropsychometric test battery
4 weeks after baseline
Mini Mental State Examination Test
4 weeks after baseline
Neuropsychiatric Inventory Questionnaire
4 weeks after baseline
Berg Balance Scale
4 weeks after baseline
Timed Up and Go Test
4 weeks after baseline
- +2 more secondary outcomes
Study Arms (3)
TMS group
EXPERIMENTALIn the TMS group (n=10) rTMS was applied to the bilateral dorsolateral prefrontal cortex (DLPFC) at 20 Hz, for 5 consecutive days per week for over 2 weeks (totally 10 sessions) in addition to the pharmacological treatment.
AE group
EXPERIMENTALAE group (n=9) received a moderate- intensity aerobic exercise program lasting 50 minutes per session, 5 consecutive days per week for over 2 weeks (totally 10 sessions) in addition to the pharmacological treatment.
Control group
ACTIVE COMPARATORNo additional intervention was given to the patients in the control group (n=8) and participants were only treated pharmacologically.
Interventions
TMS is a non-invasive application that induces changes in neuronal polarization and activity by causing the induction of weak electric currents in a rapidly changing magnetic field. Repetitive TMS (rTMS) refers to the application of regular TMS pulses at fixed intervals.
Brisk exercise that promotes the circulation of oxygen through the blood and is associated with an increased rate of breathing.
Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.
Eligibility Criteria
You may qualify if:
- having clinical AD diagnosis according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association) criteria
- being 60 years and older
- having Clinical Dementia Rating Scale (CDR) scores 1 or 2
- living independently
You may not qualify if:
- not being able to walk independently,
- having physical disabilities,
- having a history of alcohol / substance abuse,
- having head trauma
- having epileptic seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medipol University
Istanbul, Beykoz, Turkey (Türkiye)
Related Publications (1)
Budak M, Bayraktaroglu Z, Hanoglu L. The effects of repetitive transcranial magnetic stimulation and aerobic exercise on cognition, balance and functional brain networks in patients with Alzheimer's disease. Cogn Neurodyn. 2023 Feb;17(1):39-61. doi: 10.1007/s11571-022-09818-x. Epub 2022 May 30.
PMID: 36704634DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 3, 2021
First Posted
November 1, 2021
Study Start
September 1, 2016
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
November 1, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share