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

October 21, 2021 updated by: Miray Budak, Istanbul Medipol University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Beykoz
      • İstanbul, Beykoz, Turkey
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Drug: Acetylcholinesterase Inhibitors
Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.
Drug: Memantine
Memantine were given for Alzheimer's disease. .
Experimental: 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.
Drug: Acetylcholinesterase Inhibitors
Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.
Drug: Memantine
Memantine were given for Alzheimer's disease. .
Other: Aerobic Exercise
Brisk exercise that promotes the circulation of oxygen through the blood and is associated with an increased rate of breathing.
Active Comparator: Control group
No additional intervention was given to the patients in the control group (n=8) and participants were only treated pharmacologically.
Drug: Acetylcholinesterase Inhibitors
Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.
Drug: Memantine
Memantine were given for Alzheimer's disease. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychometric test battery
Time Frame: 4 weeks after baseline
Neuropsychometric status was evaluated with Neuropsychometric test battery. Higher score means better result.
4 weeks after baseline
Mini Mental State Examination Test
Time Frame: 4 weeks after baseline
General cognition was evaluated with Mini Mental State Examination Test. The functions of the individual, which are gathered under five basic headings as orientation, recording memory, attention, calculation, recall and language, are evaluated over 30 points. Higher score means better result.
4 weeks after baseline
Neuropsychiatric Inventory Questionnaire
Time Frame: 4 weeks after baseline

Neuropsychiatric status was evaluated with The Neuropsychiatric Inventory Questionnaire.

A total of 12 behavioral domain screening questions, including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/apathy, disinhibition, irritability/lability, abnormal motor behavior, sleep/night behaviors, appetite and eating changes. questioned according to the presence of symptoms. Otherwise, the next area is passed, and if there is, it is detailed with more specific questions related to that area. Multiplying the scores of the frequency and severity of the symptom creates the total score of that item. Higher score means worse result.
4 weeks after baseline
Berg Balance Scale
Time Frame: 4 weeks after baseline
Balance was evaluated with Berg Balance Scale. It consists of 14 questions that evaluate whether the tasks related to balance can be fulfilled in a spectrum ranging from sitting position to standing up and standing on one leg. It is scored as 0: unable to do, 4: doing independently. The total score is 56. A fall risk of 0-20 is considered high, a fall risk of 21-40 is considered moderate, and a fall risk of 41-56 is low. Changes of 8 points or more are considered significant in terms of addiction status.Higher score means better result.
4 weeks after baseline
Timed Up and Go Test
Time Frame: 4 weeks after baseline
Functional mobility was evaluated with Timed Up and Go Test. Time is started as soon as the person gets up from the chair and ends when he/she sits on the chair after walking 3 meters and turning. The fact that the person's walking speed is higher than the upper limit of the value range determined for the age group is associated with impaired performance. Higher score means better result.
4 weeks after baseline
Quality of Life in Alzheimer's Disease Scale
Time Frame: 4 weeks after baseline

Quality of life was evaluated with Quality of Life in Alzheimer's Disease Measure.

Each of the 13 items in the scale is scored on a four-point scale ranging from 1 (very poor) to 4 (excellent). The total score is between 13-52. Higher score means better result.
4 weeks after baseline
Frontal Behavioral Inventory
Time Frame: 4 weeks after baseline
Behavioral status was evaluated with The Frontal Behavioral Inventory. It consists of 24 items including behavior and personality traits. Scoring of the scale; 0 = absent, 1 = mild / rare, 2 = moderate, 3 = severe / most of the time. The total score ranges from 0 to 72. Higher score means worse result.
4 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

November 1, 2021

Last Update Submitted That Met QC Criteria

October 21, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alzheimer.rTMS.fMRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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