Cognitive Enhancement Through Transcranial Laser Therapy
NCT ID: NCT02851173
Last Updated: 2023-10-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2016-02-21
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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).
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.
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.
Interventions
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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).
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.
Eligibility Criteria
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Inclusion Criteria
* Participants with Mild Cognitive Impairment
Exclusion Criteria
* 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
45 Years
ALL
Yes
Sponsors
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University of Texas at Austin
OTHER
Responsible Party
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Andreana P. Haley
Associate Professor
Principal Investigators
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Andreana Haley, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Austin
Locations
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University of Texas at Austin
Austin, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-09-0018
Identifier Type: -
Identifier Source: org_study_id
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