The Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

NCT ID: NCT05102045

Last Updated: 2021-11-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Keywords

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Alzheimer's Disease Repetitive Transcranial Magnetic Stimulation Cognitive Function Aerobic Exercise Functional MRI Resting State Networks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TMS group

In 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.

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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.

Acetylcholinesterase Inhibitors

Intervention Type DRUG

Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.

Memantine

Intervention Type DRUG

Memantine were given for Alzheimer's disease. .

AE group

AE 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.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type OTHER

Brisk exercise that promotes the circulation of oxygen through the blood and is associated with an increased rate of breathing.

Acetylcholinesterase Inhibitors

Intervention Type DRUG

Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.

Memantine

Intervention Type DRUG

Memantine were given for Alzheimer's disease. .

Control group

No additional intervention was given to the patients in the control group (n=8) and participants were only treated pharmacologically.

Group Type ACTIVE_COMPARATOR

Acetylcholinesterase Inhibitors

Intervention Type DRUG

Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.

Memantine

Intervention Type DRUG

Memantine were given for Alzheimer's disease. .

Interventions

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Repetitive Transcranial Magnetic Stimulation

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.

Intervention Type DEVICE

Aerobic Exercise

Brisk exercise that promotes the circulation of oxygen through the blood and is associated with an increased rate of breathing.

Intervention Type OTHER

Acetylcholinesterase Inhibitors

Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.

Intervention Type DRUG

Memantine

Memantine were given for Alzheimer's disease. .

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* not being able to walk independently,
* having physical disabilities,
* having a history of alcohol / substance abuse,
* having head trauma
* having epileptic seizures
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Miray Budak

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 36704634 (View on PubMed)

Other Identifiers

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Alzheimer.rTMS.fMRI

Identifier Type: -

Identifier Source: org_study_id