Alzheimer DiseaseNCT05784298
Acute Effect of Low-intensity Gamma rTMS on Cognitive and EEG Parameters in Adults With Mild Dementia by Alzheimer's Disease
A study testing low-intensity rTMS in people with Alzheimer Disease and Mild Dementia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Neurocognitive disorders have a growing prevalence and impact on public health; their main etiology corresponds to Alzheimer's disease. To date, there is no treatment that can reverse neuronal damage in these pathologies. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Dementia
- What is being tested?
- low-intensity rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteMexico
- Study dates
- 28 Apr 2022to 28 Sep 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Both sexes
- Age over 65 years old
- Who give written informed consent
- Patients with a diagnosis compatible with mild dementia according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association, 1984) criteria.
- CDR 1
- Preserved or corrected ability to see and hear
- Have a formal or informal caregiver
Who cannot join
- Clinical diagnosis of a neurodegenerative disease other than mild dementia due to Alzheimer's disease
- Present an uncontrolled medical condition at the time of the assessment for admission to the protocol (diabetes, heart disease, hypertension, hypothyroidism, uncontrolled renal or hepatic insufficiency).
- Diagnosis of major depression and/or some other untreated psychiatric illness (calculated with GDS)
- Excessive alcohol use
- Current or recent (6 months) use of any neurostimulation methods
- Metal implants excluding dental
Show all 17Show fewer
- Signs or symptoms of increased intracranial pressure
- History of having received electroconvulsive therapy.
- Suffering from epilepsy.
- Having a deep brain stimulator implanted.
- Having any metallic prosthesis in the head.
- Having a pacemaker
- Extensive tattoos
- Taking any of the following medications:
- Tricyclic antidepressants such as: imipramine, amitriptyline, doxepin, nostriptyline, matroptyline.
- Antivirals such as: foscarnet, ganciclovir, ritonavir, dissociative anesthetics such as: phencyclidine, ketamine, γ-hydroxybutyrate
- Other stimulant drugs such as: amphetamines, cocaine, MDMA (ecstasy)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, 14080
About this study
Official title: Acute Effect of Low-intensity Gamma Repetitive Transcranial Magnetic Stimulation on Cognitive and EEG Parameters in Older Adults With Mild Dementia by Alzheimer's Disease: a Randomized, Double-blind, Crossover, Controlled Trial
Neurocognitive disorders have a growing prevalence and impact on public health; their main etiology corresponds to Alzheimer's disease. To date, there is no treatment that can reverse neuronal damage in these pathologies. However, several non-invasive neuromodulation techniques, including transcranial magnetic stimulation, have been proposed as a viable option to halt the progression of the disease.
Transcranial magnetic stimulation (TMS) is a noninvasive, nonpainful neurostimulation technique with a high safety profile that has been successfully used to improve cognitive function in subjects with mild cognitive impairment. Our research group conducted a study that showed that the use of low-intensity TMS at gamma frequencies is a safe, non-invasive method with minimal adverse effects.
Read more
The present protocol proposes a new randomized, double-blind, crossover trial to be conducted in memory clinic patients over 65 years of age who meet the diagnosis of mild dementia due to Alzheimer's disease. The main objective is to evaluate the short-term cognitive and electroencephalographic changes produced by low-intensity, gamma-frequency transcranial magnetic stimulation.
A TMS device that emits a pulsed magnetic field at a frequency of 40 Hz, with a maximum magnitude of 150 gauss for 45 minutes will be used as an intervention. The intervention will be of two types, real or simulated, and will be applied twice to each patient, that is, in one session they will receive the real stimulation and in another the simulated one. In addition, during the sessions, cognitive and electroencephalographic measurements will be taken before, during and after each intervention. Each of these stimulation sessions should be separated by at least one week.
- Conditions
- Alzheimer Disease, Mild Dementia
- Being tested
- low-intensity rTMS
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-intensity rTMSDevice
40 hz, 150 gauss, 1 session that lasts 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Real low-intensity rTMS | Experimental | One 45 minutes session of stimulation. The stimulation coil will be located in the precuneus, located in the Pz area of the 10-20. The coil will emit a pulsed magnetic field at a frequency of 40 Hz with a magnetic field strength of 150 gauss. Receives: Device: low-intensity rTMS |
| Sham low-intensity rTMS | Sham comparator | One 45 minutes session of stimulation. The stimulation coil will be located in the precuneus, located in the Pz area of the 10-20. The coil will not emit any magnetic field. Receives: Device: low-intensity rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in EEG gamma band activity
Measured: Baseline (1 second before stimulation burst) - Post (1 second after stimulation burst)
Secondary outcomes (3)
Changes in Face-Name Associative Memory Test scores
The Face-Name Associative Memory Test is a cross-modal associative memory test, it includes 20 face-name pairs. The administration procedure starts with the presentation of 20 faces with each name and participants should read the name underneath the faces and try to learn each face-name pair. After 5 minutes, the faces are shown one by one and participants are asked to recall the associated names from 4 different names. The correct number of pairs recalled is recorded.
Measured: Baseline (the last 10 minutes of the intervention) - Post (one week later, the last 10 minutes of the intervention)
Change from baseline in phonological and semantic verbal fluency test
The participant must say the largest number of words of a semantic category for one minute and then the largest number of words beginning with a given phoneme, also for one minute.
Two versions of these tests are applied, one during baseline and one after stimulation.
The order of application of the versions changes in the first and second sessions. That is, if in the first session they started with version 1 in the baseline and version 2 in the post, then in the second session they will start with version 2 and then version 1.
There is a one week difference between the first and second session.
The results obtained in the stimulation session and the sham session will be compared.
Measured: Baseline (immediately before the intervention) - Post (Immediately after the intervention: 60 minutes approximately)
Changes in Rey Auditory Verbal Learning Test scores
Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the patient must again repeat the original list of 15 words and then again after 20 minutes.
The score ranges from 0 (worse performance) to 15 (best performance).
Two versions of this test are applied, one during baseline and one after stimulation.
The order of application of the versions changes in the first and second sessions. That is, if in the first session one started with version 1 at baseline and version 2 at post, in the second session one will start with version 2 and then version 1.
There is a one week difference between the first and second session.
The results obtained in the stimulation session and the sham session will be compared.
Measured: Baseline (immediately before the intervention) - Post (Immediately after the intervention: 60 minutes approximately))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start28 Apr 2022
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784298
- Sponsor's protocol ID
- GER-4088-22-23-1
- Status last verified
- Oct 2023
- First submitted
- 31 Aug 2022
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mimenza-Alvarado AJ, Aguilar-Navarro SG, Abarca-Jimenez IE, Vazquez-Villasenor I, Luna-Umanzor DI, Dorard C, Villafuerte G. Low intensity gamma-frequency TMS safely modulates gamma oscillations in probable mild Alzheimer's dementia: a randomized 2 x 2 crossover pilot study. Front Neurol. 2025 May 15;16:1566476. doi: 10.3389/fneur.2025.1566476. eCollection 2025.
PubMed 40443505
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Low-intensity Gamma Repetitive Transcranial Magnetic Stimulation on Cognitive and EEG Parameters in Older Adults With Mild Dementia by Alzheimer's Disease: a Randomized, Double-blind, Crossover, Controlled Trial
- ClinicalTrials.gov ID
- NCT05784298
- Acronym / sponsor ID
- GER-4088-22-23-1
- Conditions
- Alzheimer Disease, Mild Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 24 Mar 2023 (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.
Neurocognitive disorders have a growing prevalence and impact on public health; their main etiology corresponds to Alzheimer's disease. To date, there is no treatment that can reverse neuronal damage in these pathologies. However, several non-invasive neuromodulation techniques, including transcranial magnetic stimulation, have been proposed as a viable option to halt the progression of the disease.
Transcranial magnetic stimulation (TMS) is a noninvasive, nonpainful neurostimulation technique with a high safety profile that has been successfully used to improve cognitive function in subjects with mild cognitive impairment. Our research group conducted a study that showed that the use of low-intensity TMS at gamma frequencies is a safe, non-invasive method with minimal adverse effects.
The present protocol proposes a new randomized, double-blind, crossover trial to be conducted in memory clinic patients over 65 years of age who meet the diagnosis of mild dementia due to Alzheimer's disease. The main objective is to evaluate the short-term cognitive and electroencephalographic changes produced by low-intensity, gamma-frequency transcranial magnetic stimulation.
A TMS device that emits a pulsed magnetic field at a frequency of 40 Hz, with a maximum magnitude of 150 gauss for 45 minutes will be used as an intervention. The intervention will be of two types, real or simulated, and will be applied twice to each patient, that is, in one session they will receive the real stimulation and in another the simulated one. In addition, during the sessions, cognitive and electroencephalographic measurements will be taken before, during and after each intervention. Each of these stimulation sessions should be separated by at least one week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real low-intensity rTMS | Experimental | Device: low-intensity rTMSOne 45 minutes session of stimulation. The stimulation coil will be located in the precuneus, located in the Pz area of the 10-20. The coil will emit a pulsed magnetic field at a frequency of 40 Hz with a magnetic field strength of 150 gauss. |
| Sham low-intensity rTMS | Sham comparator | Device: low-intensity rTMSOne 45 minutes session of stimulation. The stimulation coil will be located in the precuneus, located in the Pz area of the 10-20. The coil will not emit any magnetic field. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Both sexes
- Age over 65 years old
- Who give written informed consent
- Patients with a diagnosis compatible with mild dementia according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association, 1984) criteria.
- CDR 1
Key exclusion criteria (17 listed)
- Clinical diagnosis of a neurodegenerative disease other than mild dementia due to Alzheimer's disease
- Present an uncontrolled medical condition at the time of the assessment for admission to the protocol (diabetes, heart disease, hypertension, hypothyroidism, uncontrolled renal or hepatic insufficiency).
- Diagnosis of major depression and/or some other untreated psychiatric illness (calculated with GDS)
- Excessive alcohol use
- Current or recent (6 months) use of any neurostimulation methods
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 |
|---|---|---|
| low-intensity rTMS40 hz, 150 gauss, 1 session that lasts 45 minutes. | Device | Real low-intensity rTMS, Sham low-intensity rTMS |
Primary outcome
Changes in EEG gamma band activity
Time frame: Baseline (1 second before stimulation burst) - Post (1 second after stimulation burst)
3 secondary outcomes
Changes in Face-Name Associative Memory Test scores
Time frame: Baseline (the last 10 minutes of the intervention) - Post (one week later, the last 10 minutes of the intervention)
Change from baseline in phonological and semantic verbal fluency test
Time frame: Baseline (immediately before the intervention) - Post (Immediately after the intervention: 60 minutes approximately)
Changes in Rey Auditory Verbal Learning Test scores
Time frame: Baseline (immediately before the intervention) - Post (Immediately after the intervention: 60 minutes approximately))
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 5 Dec 2023.
- Derived from this study: PubMed 40443505Mimenza-Alvarado AJ, Aguilar-Navarro SG, Abarca-Jimenez IE, Vazquez-Villasenor I, Luna-Umanzor DI, Dorard C, Villafuerte G. Low intensity gamma-frequency TMS safely modulates gamma oscillations in probable mild Alzheimer's dementia: a randomized 2 x 2 crossover pilot study. Front Neurol. 2025 May 15;16:1566476. doi: 10.3389/fneur.2025.1566476. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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 low-intensity rTMS in people with Alzheimer Disease and Mild Dementia, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 7 inclusion and 17 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 5 Dec 2023. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
Changes in EEG gamma band activity (time frame: Baseline (1 second before stimulation burst) - Post (1 second after stimulation burst)). 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 NCT05784298, 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 5 Dec 2023.