search
Back to results

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

Primary Purpose

Alzheimer Disease, Mild Dementia

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
low-intensity rTMS
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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. Antivirals such as: foscarnet, ganciclovir, ritonavir, dissociative anesthetics such as: phencyclidine, ketamine, γ-hydroxybutyrate Other stimulant drugs such as: amphetamines, cocaine, MDMA (ecstasy)

Sites / Locations

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador ZubiránRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real low-intensity rTMS

Sham low-intensity rTMS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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. The score ranges from 0 (worse performance) to 20 (best performance). This task is performed during the last 10 minutes receiving stimulation or sham, both in the first and second sessions, in the same order of application. 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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 31, 2022
Last Updated
March 22, 2023
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
search

1. Study Identification

Unique Protocol Identification Number
NCT05784298
Brief Title
Acute Effect of Low-intensity Gamma rTMS on Cognitive and EEG Parameters in Adults With Mild Dementia by Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
April 28, 2023 (Anticipated)
Study Completion Date
April 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mild Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real low-intensity rTMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham low-intensity rTMS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
low-intensity rTMS
Intervention Description
40 hz, 150 gauss, 1 session that lasts 45 minutes.
Primary Outcome Measure Information:
Title
Changes in Face-Name Associative Memory Test scores
Description
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. The score ranges from 0 (worse performance) to 20 (best performance). This task is performed during the last 10 minutes receiving stimulation or sham, both in the first and second sessions, in the same order of application. 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.
Time Frame
Baseline (the last 10 minutes of the intervention) - Post (one week later, the last 10 minutes of the intervention)
Secondary Outcome Measure Information:
Title
Change from baseline in phonological and semantic verbal fluency test
Description
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.
Time Frame
Baseline (immediately before the intervention) - Post (Immediately after the intervention: 60 minutes approximately)
Title
Changes in Rey Auditory Verbal Learning Test scores
Description
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.
Time Frame
Baseline (immediately before the intervention) - Post (Immediately after the intervention: 60 minutes approximately))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. Antivirals such as: foscarnet, ganciclovir, ritonavir, dissociative anesthetics such as: phencyclidine, ketamine, γ-hydroxybutyrate Other stimulant drugs such as: amphetamines, cocaine, MDMA (ecstasy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alberto Mimenza
Phone
54870900
Ext
5701
Email
a.mimenza@hotmail.com
Facility Information:
Facility Name
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs