Cognitive Enhancement Through Transcranial Laser Therapy
Raktažodžiai
Santrauka
apibūdinimas
The goal of this project is to test the efficacy of LLLT to enhance neurocognitive function in middle-aged adults and examine the modulating influences of carotid atherosclerosis. The specific aims will be accomplished in a randomized controlled trial (RCT) by examining cognitive test performance and blood oxygen level-dependent (BOLD) response to a working memory task in middle-aged and older adults and participants with Mild Cognitive Impairment pre- and post- six-week long intervention of LLLT or placebo. In addition, the investigators will examine if carotid artery intima-media thickness (IMT) moderates the therapeutic effects of LLLT.
Datos
| Paskutinį kartą patikrinta: | 01/31/2019 |
| Pirmasis pateikimas: | 07/26/2016 |
| Numatytas registravimas pateiktas: | 07/26/2016 |
| Pirmas paskelbtas: | 07/31/2016 |
| Paskutinis atnaujinimas pateiktas: | 02/18/2019 |
| Paskutinis atnaujinimas paskelbtas: | 02/20/2019 |
| Faktinė studijų pradžios data: | 02/20/2016 |
| Numatoma pirminio užbaigimo data: | 07/31/2020 |
| Numatoma studijų užbaigimo data: | 07/31/2020 |
Būklė ar liga
Intervencija / gydymas
Device: LLLT
Device: Placebo
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: LLLT Six weekly sessions of LLLT. The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA). Each laser stimulation session will consist of total 8 min, with eight 1 min/cycle treatments alternating between two locations on the right forehead. | Device: LLLT The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA). |
| Active Comparator: Placebo The control group will undergo the same procedure as the treatment group, but will receive brief (5-s) stimulation to the intended site on the forehead, followed by 55 s of no stimulation, for each 1-min cycle. Thus the control group will receive approximately 1/12th of the cumulative energy density as the treatment group. This is sufficient to provide a brief sensation of slight heat (as active placebo) at the onset of each one-minute cycle, using a fraction of the energy received by the experimental group. | Device: Placebo The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA). However, the placebo group will receive approximately 1/12th of the cumulative energy density as the treatment group. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 45 Years Į 45 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | Inclusion Criteria: - Men and postmenopausal women, aged 45 and older - Participants with Mild Cognitive Impairment Exclusion Criteria: - neurological disease (e.g., large vessel stroke, seizure disorder, Parkinson's disease, Alzheimer's disease, clinically significant traumatic brain injury with loss of consciousness > 30 minutes, multiple sclerosis, or brain infection/meningitis - baseline IQ < 85 placing them below the average range of intellectual functioning - major psychiatric illness (e.g., schizophrenia, bipolar disorder) or substance abuse (diagnosed abuse and/or previous hospitalization for substance abuse) - severe cardiovascular disease (e.g., pacemaker), chronic obstructive pulmonary disease, liver or kidney disease, inflammatory illness |
Rezultatas
Pirminės rezultatų priemonės
1. Psychomotor vigilance task (PVT) [8 weeks]
Antrinės rezultatų priemonės
1. BOLD response to working memory task (2 back task) [8 weeks]
2. Working memory (2 back task) [8 weeks]
