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.

Mild Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03983655
• Other study ID #: GER-2962-19-20-1
• Status: Terminated
• Phase: N/A
• Start date: May 17, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2021
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: August 1, 2020
• Est. primary completion date: May 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Mild Dementia

Intervention

Device:
• High Frequency Low Intensity TMS
125 hz, 10 gauss, 2 times daily for 6 monts

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Actipulse Neuroscience

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients suffering any kind of adverse effect		6 months
Secondary	Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months		3 months
Secondary	Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months		6 months
Secondary	Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months		3 months
Secondary	Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months		6 months
Secondary	Change from baseline of total Geriatric Depression Scale at 3 months		3 months
Secondary	Change from baseline of total Geriatric Depression Scale at 6 months		6 months
Secondary	Change from baseline of total Montreal Cognitive Assessment at 3 months		3 months
Secondary	Change from baseline of total Montreal Cognitive Assessment at 6 monts		6 months
Secondary	Change from baseline of total Frontal Asessment Battery at 3 monts		3 months
Secondary	Change from baseline Frontal Asessment Battery at 6 monts		6 months
Secondary	Change from baseline ADAS-COG at 6 monts	Alzheimer´s Disease Assessment Scale-Cognitive	6 months