Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia.

Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia: A Randomized, Double Blind, Parallel Group, Sham Controlled Clinical Trial

There are no pharmacological interventions that delay or prevent the transition of mild cognitive impairment to dementia. Several studies have shown that transcranial magnetic stimulation (TMS) could be useful in increasing cognitive traits in dementia.

As TMS is performed in a clinical setting, transportation, mobility and high costs of treatment, limit the number of TMS sessions dementia patients can receive. Most of the trials do not apply more than 20 TMS sessions

Here, a randomized, sham controlled, paralallel group, clinical trial will be performed in order to asess the efficacy at improving cognitive traits of a novel TMS device that uses high frequency and low intensity pulses. As the device is portable and can be used from home without clinical supervision, the stimulation will be applied two times per day for a period of 6 months.

Study Overview

• Status: Terminated
• Conditions: Mild Cognitive Impairment; Mild Dementia
• Intervention / Treatment: Device: High Frequency Low Intensity TMS

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

IInclusion Criteria:

( - ) CDR less or equal to 1 ( - ) Mild cognitive impairment by Petersen criteria ( - ) Conserved or corrected sight ( - ) Enrolled at INCMNSZ for medical care ( - ) Be able to read and write ( - ) Willing and able to provide written informed consent

Exclusion Criteria:

( - ) Other neurodegenerative disorder different than mild cognitive impairment or mild dementia ( - ) Metabolic disease without medical care ( - ) Epilepsy ( - ) Deep brain stimulator ( - ) Metalic prosthethics in the skulls ( - ) Major depressive disorder ( - ) Previous utilization of other neuromodulation technique ( - ) Signs or symptoms of increased intracraneal pressure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Real High Frequency Low Intensity TMS; Two sessions of transcranial magnetic stimulation each day for 6 monts. The coil of the device emits a pulsed magnetic field at an aproximate frequency of 125 hz and an intensity of 10 gauss.	Device: High Frequency Low Intensity TMS; 125 hz, 10 gauss, 2 times daily for 6 monts
SHAM_COMPARATOR: Sham High Frequency Low Intensity TMS; Two sessions of transcranial magnetic stimulation each day for 6 monts. The coil of the device does not emit a magnetic field.	Device: High Frequency Low Intensity TMS; 125 hz, 10 gauss, 2 times daily for 6 monts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients suffering any kind of adverse effect	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months		3 months
Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months		6 months
Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months		3 months
Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months		6 months
Change from baseline of total Geriatric Depression Scale at 3 months		3 months
Change from baseline of total Geriatric Depression Scale at 6 months		6 months
Change from baseline of total Montreal Cognitive Assessment at 3 months		3 months
Change from baseline of total Montreal Cognitive Assessment at 6 monts		6 months
Change from baseline of total Frontal Asessment Battery at 3 monts		3 months
Change from baseline Frontal Asessment Battery at 6 monts		6 months
Change from baseline ADAS-COG at 6 monts	Alzheimer´s Disease Assessment Scale-Cognitive	6 months

Collaborators and Investigators

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborators: Actipulse Neuroscience

Publications and helpful links

General Publications

• Mimenza-Alvarado AJ, Aguilar-Navarro SG, Martinez-Carrillo FM, Rios-Ponce AE, Villafuerte G. Use of Fast Gamma Magnetic Stimulation Over the Left Prefrontal Dorsolateral Cortex for the Treatment of MCI and Mild Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled, Pilot Study. Front Neurol. 2021 Sep 9;12:729872. doi: 10.3389/fneur.2021.729872. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2019
• Primary Completion (ACTUAL): May 17, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (ACTUAL): June 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction
• Other Study ID Numbers: GER-2962-19-20-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No