Alzheimer DiseaseNCT05102045
The Effects of Repetitive Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
A study testing Repetitive Transcranial Magnetic Stimulation, Aerobic Exercise and Acetylcholinesterase Inhibitors in people with Alzheimer Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation, Aerobic Exercise and Acetylcholinesterase Inhibitors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2016to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not being able to walk independently,
- having physical disabilities,
- having a history of alcohol / substance abuse,
- having head trauma
- having epileptic seizures
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Alzheimer Disease
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Aerobic Exercise, Acetylcholinesterase Inhibitors, Memantine
- Keywords
- Alzheimer's Disease, Repetitive Transcranial Magnetic Stimulation, Cognitive Function, Aerobic Exercise, Functional MRI, Resting State Networks
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
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.
Aerobic ExerciseOther
Brisk exercise that promotes the circulation of oxygen through the blood and is associated with an increased rate of breathing.
Acetylcholinesterase InhibitorsDrug
Donepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease.
MemantineDrug
Memantine were given for Alzheimer's disease. .
| Study group | Role | What they receive |
|---|---|---|
| TMS group | Experimental | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Drug: Acetylcholinesterase Inhibitors; Drug: Memantine |
| AE group | Experimental | 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. Receives: Other: Aerobic Exercise; Drug: Acetylcholinesterase Inhibitors; Drug: Memantine |
| Control group | Active comparator | No additional intervention was given to the patients in the control group (n=8) and participants were only treated pharmacologically. Receives: Drug: Acetylcholinesterase Inhibitors; Drug: Memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Magnetic Resonance Imaging
Resting state networks and activation areas in the brain were evaluating with Functional Magnetic Resonance Imaging
Measured: 4 weeks after baseline
Secondary outcomes (7)
Neuropsychometric test battery
Neuropsychometric status was evaluated with Neuropsychometric test battery. Higher score means better result.
Measured: 4 weeks after baseline
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.
Measured: 4 weeks after baseline
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.
Measured: 4 weeks after baseline
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.
Measured: 4 weeks after baseline
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.
Measured: 4 weeks after baseline
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.
Measured: 4 weeks after baseline
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.
Measured: 4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Sep 2016
- Primary completion1 May 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miray Budak, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102045
- Sponsor's protocol ID
- Alzheimer.rTMS.fMRI
- Status last verified
- Oct 2021
- First submitted
- 3 Aug 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36704634
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05102045
- Acronym / sponsor ID
- Alzheimer.rTMS.fMRI
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's Disease, Repetitive Transcranial Magnetic Stimulation, Cognitive Function, Aerobic Exercise, Functional MRI, Resting State Networks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TMS group | Experimental | Device: Repetitive Transcranial Magnetic Stimulation, Drug: Acetylcholinesterase Inhibitors, Drug: MemantineIn 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 | Experimental | Other: Aerobic Exercise, Drug: Acetylcholinesterase Inhibitors, Drug: MemantineAE 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 comparator | Drug: Acetylcholinesterase Inhibitors, Drug: MemantineNo additional intervention was given to the patients in the control group (n=8) and participants were only treated pharmacologically. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- not being able to walk independently,
- having physical disabilities,
- having a history of alcohol / substance abuse,
- having head trauma
- having epileptic seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationTMS 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. | Device | TMS group |
| Aerobic ExerciseBrisk exercise that promotes the circulation of oxygen through the blood and is associated with an increased rate of breathing. | Other | AE group |
| Acetylcholinesterase InhibitorsDonepezil, Rivastigmine, Galantamine were given in combination for Alzheimer's disease. | Drug | AE group, Control group, TMS group |
| MemantineMemantine were given for Alzheimer's disease. . | Drug | AE group, Control group, TMS group |
Primary outcome
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
7 secondary outcomes
Neuropsychometric test battery
Time frame: 4 weeks after baseline
Mini Mental State Examination Test
Time frame: 4 weeks after baseline
Neuropsychiatric Inventory Questionnaire
Time frame: 4 weeks after baseline
Berg Balance Scale
Time frame: 4 weeks after baseline
Timed Up and Go Test
Time frame: 4 weeks after baseline
Quality of Life in Alzheimer's Disease Scale
Time frame: 4 weeks after baseline
Frontal Behavioral Inventory
Time frame: 4 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 36704634Budak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation, Aerobic Exercise and Acetylcholinesterase Inhibitors in people with Alzheimer Disease, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Magnetic Resonance Imaging (time frame: 4 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05102045, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.