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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Aerobic Exercise
Acetylcholinesterase Inhibitors
Memantine
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's Disease, Repetitive Transcranial Magnetic Stimulation, Cognitive Function, Aerobic Exercise, Functional MRI, Resting State Networks

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

TMS group

AE group

Control group

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Neuropsychometric test battery
Neuropsychometric status was evaluated with Neuropsychometric test battery. Higher score means better result.
Mini Mental State Examination Test
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.
Neuropsychiatric Inventory Questionnaire
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.
Berg Balance Scale
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.
Timed Up and Go Test
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.
Quality of Life in Alzheimer's Disease Scale
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.
Frontal Behavioral Inventory
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.

Full Information

First Posted
August 3, 2021
Last Updated
October 21, 2021
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05102045
Brief Title
The Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
Official Title
The Effects of Repetitive Transcranial Magnetic Stimulation and Aerobic Exercise on Cognition, Balance and Functional Brain Networks in Patients With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
May 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's Disease, Repetitive Transcranial Magnetic Stimulation, Cognitive Function, Aerobic Exercise, Functional MRI, Resting State Networks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMS group
Arm Type
Experimental
Arm Description
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.
Arm Title
AE group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
No additional intervention was given to the patients in the control group (n=8) and participants were only treated pharmacologically.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
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
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
Brisk exercise that promotes the circulation of oxygen through the blood and is associated with an increased rate of breathing.
Intervention Type
Drug
Intervention Name(s)
Acetylcholinesterase Inhibitors
Intervention Description
Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.
Intervention Type
Drug
Intervention Name(s)
Memantine
Intervention Description
Memantine were given for Alzheimer's disease. .
Primary Outcome Measure Information:
Title
Functional Magnetic Resonance Imaging
Description
Resting state networks and activation areas in the brain were evaluating with Functional Magnetic Resonance Imaging
Time Frame
4 weeks after baseline
Secondary Outcome Measure Information:
Title
Neuropsychometric test battery
Description
Neuropsychometric status was evaluated with Neuropsychometric test battery. Higher score means better result.
Time Frame
4 weeks after baseline
Title
Mini Mental State Examination Test
Description
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.
Time Frame
4 weeks after baseline
Title
Neuropsychiatric Inventory Questionnaire
Description
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.
Time Frame
4 weeks after baseline
Title
Berg Balance Scale
Description
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.
Time Frame
4 weeks after baseline
Title
Timed Up and Go Test
Description
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.
Time Frame
4 weeks after baseline
Title
Quality of Life in Alzheimer's Disease Scale
Description
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.
Time Frame
4 weeks after baseline
Title
Frontal Behavioral Inventory
Description
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.
Time Frame
4 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Istanbul Medipol University
City
İstanbul
State/Province
Beykoz
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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