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.

• Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03983655
• Collaborator: Actipulse Neuroscience (Other)
• Enrollment: 37
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment; Mild Dementia	Device: High Frequency Low Intensity TMS	N/A

Study Design

• Study Type: Interventional
• 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: Aug 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Proportion of patients suffering any kind of adverse effect [6 months]

Secondary Outcome Measures

1. Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months [3 months]

2. Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months [6 months]

3. Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months [3 months]

4. Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months [6 months]

5. Change from baseline of total Geriatric Depression Scale at 3 months [3 months]

6. Change from baseline of total Geriatric Depression Scale at 6 months [6 months]

7. Change from baseline of total Montreal Cognitive Assessment at 3 months [3 months]

8. Change from baseline of total Montreal Cognitive Assessment at 6 monts [6 months]

9. Change from baseline of total Frontal Asessment Battery at 3 monts [3 months]

10. Change from baseline Frontal Asessment Battery at 6 monts [6 months]

11. Change from baseline ADAS-COG at 6 monts [6 months]

    Alzheimer´s Disease Assessment Scale-Cognitive

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jun 12, 2019
• Last Update Posted: Aug 12, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dementia; Cognitive Dysfunction

Study Results

No Results Posted as of Aug 12, 2021