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.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran37 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

TRIPLE

Enrollment

Conditions

Mild Cognitive Impairment Mild Dementia

Interventions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patients suffering any kind of adverse effect

Time frame: 6 months

Secondary Outcomes

Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months

Time frame: 3 months

Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months

Time frame: 6 months

Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months

Time frame: 3 months

Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months

Time frame: 6 months

Change from baseline of total Geriatric Depression Scale at 3 months

Time frame: 3 months

Change from baseline of total Geriatric Depression Scale at 6 months

Time frame: 6 months

Change from baseline of total Montreal Cognitive Assessment at 3 months

Time frame: 3 months

Change from baseline of total Montreal Cognitive Assessment at 6 monts

Time frame: 6 months

Change from baseline of total Frontal Asessment Battery at 3 monts

Time frame: 3 months

Change from baseline Frontal Asessment Battery at 6 monts

Time frame: 6 months

Change from baseline ADAS-COG at 6 monts

Alzheimer´s Disease Assessment Scale-Cognitive

Time frame: 6 months

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.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes