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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03983655
Recruitment Status : Terminated (COVID-19 pandemic)
First Posted : June 12, 2019
Last Update Posted : August 12, 2021
Sponsor:
Collaborator:
Actipulse Neuroscience
Information provided by (Responsible Party):
Alberto José Mimenza Alvarado, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Mild Dementia Device: High Frequency Low Intensity TMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Device Feasibility
Official Title: 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
Actual Study Start Date : May 17, 2019
Actual Primary Completion Date : May 17, 2020
Actual Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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




Primary Outcome Measures :
  1. Proportion of patients suffering any kind of adverse effect [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months [ Time Frame: 3 months ]
  2. Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months [ Time Frame: 6 months ]
  3. Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months [ Time Frame: 3 months ]
  4. Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months [ Time Frame: 6 months ]
  5. Change from baseline of total Geriatric Depression Scale at 3 months [ Time Frame: 3 months ]
  6. Change from baseline of total Geriatric Depression Scale at 6 months [ Time Frame: 6 months ]
  7. Change from baseline of total Montreal Cognitive Assessment at 3 months [ Time Frame: 3 months ]
  8. Change from baseline of total Montreal Cognitive Assessment at 6 monts [ Time Frame: 6 months ]
  9. Change from baseline of total Frontal Asessment Battery at 3 monts [ Time Frame: 3 months ]
  10. Change from baseline Frontal Asessment Battery at 6 monts [ Time Frame: 6 months ]
  11. Change from baseline ADAS-COG at 6 monts [ Time Frame: 6 months ]
    Alzheimer´s Disease Assessment Scale-Cognitive



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983655


Locations
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Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Actipulse Neuroscience
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alberto José Mimenza Alvarado, Principal Investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT03983655    
Other Study ID Numbers: GER-2962-19-20-1
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders