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.

NCT03983655 | Terminated

• 1 other identifier: GER-2962-19-20-1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Mild Dementia

Outcome Measures

Primary Outcomes (1)

• Proportion of patients suffering any kind of adverse effect

  6 months

Secondary Outcomes (11)

• 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

• 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

Study Arms (2)

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.

Device: High Frequency Low Intensity TMS

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.

Device: High Frequency Low Intensity TMS

Interventions

High Frequency Low Intensity TMS DEVICE

125 hz, 10 gauss, 2 times daily for 6 monts

Real High Frequency Low Intensity TMS; Sham High Frequency Low Intensity TMS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ( - ) 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

You may not qualify if:

• ( - ) 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Actipulse Neuroscience: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

Location

Related Publications (1)

• 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.

  PMID: 34566873 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 12, 2019
• Study Start: May 17, 2019
• Primary Completion: May 17, 2020
• Study Completion: August 1, 2020
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)