Clinical trial NCT02851173: Cognitive Enhancement Through Transcranial Laser Therapy
Official title: Cognitive Enhancement Through Transcranial Laser Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Participants
Mild Cognitive Impairment
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 91
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a mechanism-driven translational project to test the efficacy of transcranial low-level light/laser therapy (LLLT), for enhancing cognitive function in middle-aged and older adults and participants with Mild Cognitive Impairment.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Psychomotor Vigilance Task (PVT)
timeFrame: Time 1 represents PVT performance (reaction time in msec) at baseline, Time 2 represents PVT performance (reaction time in msec) six weeks later.
Secondary outcomes:
measure: Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task
timeFrame: T1 represents score at baseline; T2 represents follow-up score, 6 weeks later
measure: Working Memory (2 Back Task)
timeFrame: T1 represents 2back % Correct at baseline; T2 represents 2back % Correct 6 weeks later
measure: Working Memory (2 Back Task)
timeFrame: T1 represents 2back Reaction Time (RT) in msec at baseline; T2 represents Reaction Time (RT) in msec 6 weeks later
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Andreana Haley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: