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COVID-19 pandemic
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| Name | Class |
|---|---|
| Actipulse Neuroscience | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real High Frequency Low Intensity TMS | Experimental | 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. |
|
| Sham High Frequency Low Intensity TMS | Sham Comparator | Two sessions of transcranial magnetic stimulation each day for 6 monts. The coil of the device does not emit a magnetic field. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Frequency Low Intensity TMS | Device | 125 hz, 10 gauss, 2 times daily for 6 monts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients suffering any kind of adverse effect | 6 months |
| 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 |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34566873 | Derived | 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. |
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| 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 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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