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The Effects of Transcranial Photobiomodulation in Adults with Mild Cognitive Impairment

The Impact of Transcranial Photobiomodulation on Adult Mild Cognitive Impairment: A Double-Blind Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8p36d5m
Enrollment
Unknown
Registered
2021-12-13
Start date
2022-02-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of life

Interventions

Intervention Group: 117 individuals diagnosed with mild cognitive impairment will receive treatment (Transcranial Photobiomodulation FBMt) through a helmet whose internal space is composed of 204 LED
E02.774

Sponsors

Universidade do Sul de Santa Catarina
Lead Sponsor
Universidade do Sul de Santa Catarina
Collaborator

Eligibility

Age
45 Years to 79 Years

Inclusion criteria

Inclusion criteria: Individuals of both sexes, with a diagnosis of Mild Cognitive Impairment will be included in this study

Exclusion criteria

Exclusion criteria: Individuals with epilepsy; hypersensitivity to light; with immunodepressive; oncological; infectious diseases or with characteristic symptoms of suspected COVID-19 infection; or confirmation of COVID-19 by test; pregnant or lactating women will be excluded from this study.

Design outcomes

Primary

MeasureTime frame
Scores between 13 and 21 points will characterize individuals with Mild Cognitive Impairment assessed using the Montreal Cognitive Assessment (MoCa) questionnaire. It will be carried out before the intervention, soon after, three and six months after the end of the treatment.

Secondary

MeasureTime frame
To assess quality of life, the standardized Short Form Health Survey 36 (SF 36) will be applied. The final score is from zero to one hundred, where zero is the worst prognosis. It will be carried out before the intervention, soon after, three and six months after the end of the treatment.;For the analysis of heart rate variability, as a means of inferring the stress conditions associated with the autonomous nervous system (ANS), the Nerve Express software will be used, which consists of a simple Polar brand heart monitor, a heart rate sensor associated with a notebook, which captures heart rate variability. The greater the heart rate variability, the more associated with good health status, the lower the variability, the more associated with chronic health problems. It will be performed before the intervention, soon after, three and six months.;Serum analysis of Tumor Necrosis Factor (TNF) interleukins: 1 Beta, 10, 6 and 8 (IL1ß, IL10, IL6 and IL8), Brain-derived neurotrophic factor (BDNF), protein B binding to calcium (S100ß), Beta enolase (ß enolase), Vitamin D and melatonin will be performed by the ELISA method (enzyme-linked immunosorbent assay) using the DuoSet ELISA kit (R&D Systems, Minnesota, MN, USA) for humans. Readings will be performed by a microplate reader adjusted to 490nm and 650nm correction. Values will be expressed in pg/ml. Serum analyzes will be performed before and after the intervention.; 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, three and six months after the end of the treatment. ;The visual analogue scale (VAS) will be the tool used to assess pain intensity. This scale consists of a horizontal line of 10 c

Countries

Brazil

Contacts

Public ContactDaniel Martins
danielmartinsfisio@hotmail.com+55(048)999185021

Outcome results

None listed

Source: REBEC (via WHO ICTRP)