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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.

Primary Purpose

Mild Cognitive Impairment, Mild Dementia

Status
Terminated
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
High Frequency Low Intensity TMS
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Mild Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real High Frequency Low Intensity TMS

Sham High Frequency Low Intensity TMS

Arm Description

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.

Two sessions of transcranial magnetic stimulation each day for 6 monts. The coil of the device does not emit a magnetic field.

Outcomes

Primary Outcome Measures

Proportion of patients suffering any kind of adverse effect

Secondary Outcome Measures

Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months
Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months
Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months
Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months
Change from baseline of total Geriatric Depression Scale at 3 months
Change from baseline of total Geriatric Depression Scale at 6 months
Change from baseline of total Montreal Cognitive Assessment at 3 months
Change from baseline of total Montreal Cognitive Assessment at 6 monts
Change from baseline of total Frontal Asessment Battery at 3 monts
Change from baseline Frontal Asessment Battery at 6 monts
Change from baseline ADAS-COG at 6 monts
Alzheimer´s Disease Assessment Scale-Cognitive

Full Information

First Posted
May 21, 2019
Last Updated
August 5, 2021
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Actipulse Neuroscience
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1. Study Identification

Unique Protocol Identification Number
NCT03983655
Brief 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.
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic
Study Start Date
May 17, 2019 (Actual)
Primary Completion Date
May 17, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators
Actipulse Neuroscience

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Mild Dementia

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real High Frequency Low Intensity TMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham High Frequency Low Intensity TMS
Arm Type
Sham Comparator
Arm Description
Two sessions of transcranial magnetic stimulation each day for 6 monts. The coil of the device does not emit a magnetic field.
Intervention Type
Device
Intervention Name(s)
High Frequency Low Intensity TMS
Intervention Description
125 hz, 10 gauss, 2 times daily for 6 monts
Primary Outcome Measure Information:
Title
Proportion of patients suffering any kind of adverse effect
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months
Time Frame
3 months
Title
Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months
Time Frame
6 months
Title
Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months
Time Frame
3 months
Title
Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months
Time Frame
6 months
Title
Change from baseline of total Geriatric Depression Scale at 3 months
Time Frame
3 months
Title
Change from baseline of total Geriatric Depression Scale at 6 months
Time Frame
6 months
Title
Change from baseline of total Montreal Cognitive Assessment at 3 months
Time Frame
3 months
Title
Change from baseline of total Montreal Cognitive Assessment at 6 monts
Time Frame
6 months
Title
Change from baseline of total Frontal Asessment Battery at 3 monts
Time Frame
3 months
Title
Change from baseline Frontal Asessment Battery at 6 monts
Time Frame
6 months
Title
Change from baseline ADAS-COG at 6 monts
Description
Alzheimer´s Disease Assessment Scale-Cognitive
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34566873
Citation
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.
Results Reference
derived

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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.

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