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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-17

Study Completion Date

2020-08-01

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.

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Detailed Description

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Conditions

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Mild Cognitive Impairment Mild Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

High Frequency Low Intensity TMS

Intervention Type DEVICE

125 hz, 10 gauss, 2 times daily for 6 monts

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.

Group Type SHAM_COMPARATOR

High Frequency Low Intensity TMS

Intervention Type DEVICE

125 hz, 10 gauss, 2 times daily for 6 monts

Interventions

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High Frequency Low Intensity TMS

125 hz, 10 gauss, 2 times daily for 6 monts

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No