Mild Cognitive Impairment, Mild Dementia
Conditions
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.
Interventions
DEVICEHigh Frequency Low Intensity TMS
125 hz, 10 gauss, 2 times daily for 6 monts
Sponsors
Actipulse Neuroscience
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients suffering any kind of adverse effect | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change from baseline of total Geriatric Depression Scale at 6 months | 6 months | — |
| Change from baseline of total Katz Index of Independence in Activities of Daily Living at 3 months | 3 months | — |
| Change from baseline of total Montreal Cognitive Assessment at 6 monts | 6 months | — |
| Change from baseline of total Frontal Asessment Battery at 3 monts | 3 months | — |
| Change from baseline Frontal Asessment Battery at 6 monts | 6 months | — |
| Change from baseline ADAS-COG at 6 monts | 6 months | Alzheimer´s Disease Assessment Scale-Cognitive |
| Change from baseline of total Montreal Cognitive Assessment at 3 months | 3 months | — |
Countries
Mexico
Outcome results
None listed