Clinical trial NCT03983655: 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
Overall status: TERMINATED
Phase: NA
Conditions: Mild Cognitive Impairment
Mild Dementia
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: Actipulse Neuroscience
First posted: 2019-06-12
Enrollment: 37
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Proportion of patients suffering any kind of adverse effect
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months
timeFrame: 3 months
measure: Change from baseline of total Katz Index of Independence in Activities of Daily Living at 6 months
timeFrame: 6 months
measure: Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 3 months
timeFrame: 3 months
measure: Change from baseline of total Lawton Instrumental Activities of Daily Living Scale at 6 months
timeFrame: 6 months
measure: Change from baseline of total Geriatric Depression Scale at 3 months
timeFrame: 3 months
measure: Change from baseline of total Geriatric Depression Scale at 6 months
timeFrame: 6 months
measure: Change from baseline of total Montreal Cognitive Assessment at 3 months
timeFrame: 3 months
measure: Change from baseline of total Montreal Cognitive Assessment at 6 monts
timeFrame: 6 months
measure: Change from baseline of total Frontal Asessment Battery at 3 monts
timeFrame: 3 months
measure: Change from baseline Frontal Asessment Battery at 6 monts
timeFrame: 6 months
measure: Change from baseline ADAS-COG at 6 monts
timeFrame: 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study officials:
References:
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.