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.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Mild Cognitive Impairment, Mild Dementia

Intervention / Treatment
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* Device: High Frequency Low Intensity TMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real High Frequency Low Intensity TMS<br>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<br>* 125 hz, 10 gauss, 2 times daily for 6 monts<br>|
| Sham Comparator: Sham High Frequency Low Intensity TMS<br>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<br>* 125 hz, 10 gauss, 2 times daily for 6 monts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |