Depression
Conditions
Interventions
This is a double-blind randomized controlled clinical trial. Intervention Group: 60 individuals diagnosed with mild cognitive impairment will receive treatment with electrical stimulation (30) in the
F1 of 2Hz, biphasic alternating pulse, pulse width of 600 us with rise time of 1 second, ON time of 5 seconds, fall time of 1 second, no ripple and 0 seconds for rest time
F2 10Hz, non-polarized pulse shape, pulse width 200 ms, rise time 1 second, ON time 5 seconds, fall time 1 second, no ripple
treatment time of 20 minutes and intensity of 600 mA or photobiomodulation (30) in the left ear cup with a red and infrared laser with a power of 1400mW, configuration of 2x70mW and GaAIAs laser diode
E02.774
E02.331.800
Sponsors
Universidade do Sul de Santa Catarina
Universidade do Sul de Santa Catarina
Eligibility
Age
60 Years to 79 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; aged between 60 and 79 years old; diagnosed with Mild Cognitive Impairment (MCI); who present Montreal Cognitive Assessment (MoCA) with a score greater than 12, without a diagnosis of dementia and less than 26 points
Exclusion criteria
Exclusion criteria: Individuals with epilepsy; immunocompromised; with oncological and infectious pathologies; diagnosis of bipolarity; pacemaker holders; participants with wounds on the ear surface due to the application of electrodes to the area; symptoms of Covid-19 or testing positive for Covid-19 during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the level of cognition using the Montreal Cognitive Assessment Assesent (MoCA). Scores between 13 and 21 points will characterize individuals with Mild Cognitive Impairment. It will be carried out before the intervention, soon after and three months after the end of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression will be measured using the Geriatric Depression Scale (GDS 15). One point is assigned to each answer and the cumulative score is evaluated in a scoring grid. The grid defines a range of 0 to 9 as "normal", 10 to 19 as "mildly depressed" and 20 to 30 as "severely depressed". It will be performed before the intervention, soon after and three months after the end of the treatment .;Anxiety will be measured using the State-Trait Anxiety Inventory (STAI), which is divided into two concepts: Trait Anxiety (A-Trait) and State Anxiety (A-State), measured by two scales of 20 items each, totaling 40 questions. The cutoff points adopted were below 20 (no anxiety), from 20 to 33 level of mild anxiety, between 33 and 49 level of medium anxiety and a score above 49 indicates a high level of anxiety. It will be performed before the intervention, soon after and three months after the end of the treatment.;The sleep quality of the participants will be evaluated using the Pittsburgh Quality of Sleep Index (PSQI-BR) tool. The instrument consists of eighteen questions and each one can score from 0 to 3. The global score results from the sum of all and can range from 0 to 18. The higher the score, the worse the sleep quality. It will be carried out before the intervention, soon after and three months after the end of the treatment. ;Assessment of cortical activation of the prefrontal cortex will be assessed using the HEG® device (BioTekna Co, Italy) which has dual wavelength light-emitting diode sources (760 and 850 nm)] with a source and a detector spaced 1.5 cm apart and placed on the forehead. Outcomes related to cortical activation will be measured by the cerebral blood oxygenation ratio (rCBO2) and cerebral blood flow (CBF), evaluated by the average of the 5 minutes of recording. The measurements collected with this equipment will be: - rCBO2: the average, minimum, maximum value, standard deviation and slope. The recordings will always take place in the morning without | — |
Countries
Brazil
Contacts
Public ContactDaniel Martins
Universidade do Sul de Santa Catarina
Outcome results
None listed