Acute Effect of Low-intensity Gamma rTMS on Cognitive and EEG Parameters in Adults With Mild Dementia by Alzheimer's Disease

NCT05784298 | Completed DMC

• 1 other identifier: GER-4088-22-23-1
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease; Mild Dementia

Outcome Measures

Primary Outcomes (1)

• Changes in EEG gamma band activity

  Baseline (1 second before stimulation burst) - Post (1 second after stimulation burst)

Secondary Outcomes (3)

• Changes in Face-Name Associative Memory Test scores

  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

  Baseline (immediately before the intervention) - Post (Immediately after the intervention: 60 minutes approximately)

• Changes in Rey Auditory Verbal Learning Test scores

  Baseline (immediately before the intervention) - Post (Immediately after the intervention: 60 minutes approximately))

Study Arms (2)

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.

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.

Device: low-intensity rTMS

Interventions

low-intensity rTMS DEVICE

40 hz, 150 gauss, 1 session that lasts 45 minutes.

Real low-intensity rTMS; Sham low-intensity rTMS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

Location

Related Publications (1)

• 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.

  PMID: 40443505 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: March 24, 2023
• Study Start: April 28, 2022
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-10

Locations

ME (1)