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Clinical Trials/NCT05102045
NCT05102045
Completed
Not Applicable

The Effects of Repetitive Transcranial Magnetic Stimulation and Aerobic Exercise on Cognition, Balance and Functional Brain Networks in Patients With Alzheimer's Disease

Istanbul Medipol University Hospital1 site in 1 country27 target enrollmentSeptember 1, 2016

Overview

Phase
Not Applicable
Intervention
Repetitive Transcranial Magnetic Stimulation
Conditions
Alzheimer Disease
Sponsor
Istanbul Medipol University Hospital
Enrollment
27
Locations
1
Primary Endpoint
Functional Magnetic Resonance Imaging
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2016
End Date
June 1, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul Medipol University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Miray Budak

Principal Investigator

Istanbul Medipol University Hospital

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Repetitive Transcranial Magnetic Stimulation

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.

Intervention: Acetylcholinesterase Inhibitors

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.

Intervention: Memantine

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.

Intervention: Aerobic Exercise

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.

Intervention: Acetylcholinesterase Inhibitors

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.

Intervention: Memantine

Control group

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

Intervention: Acetylcholinesterase Inhibitors

Control group

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

Intervention: Memantine

Outcomes

Primary Outcomes

Functional Magnetic Resonance Imaging

Time Frame: 4 weeks after baseline

Resting state networks and activation areas in the brain were evaluating with Functional Magnetic Resonance Imaging

Secondary Outcomes

  • Timed Up and Go Test(4 weeks after baseline)
  • Frontal Behavioral Inventory(4 weeks after baseline)
  • Neuropsychometric test battery(4 weeks after baseline)
  • Mini Mental State Examination Test(4 weeks after baseline)
  • Neuropsychiatric Inventory Questionnaire(4 weeks after baseline)
  • Quality of Life in Alzheimer's Disease Scale(4 weeks after baseline)
  • Berg Balance Scale(4 weeks after baseline)

Study Sites (1)

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