Cognitive Enhancement Through Transcranial Laser Therapy

Mild Cognitive Impairment Clinical Trial

— LLLT  

Official title:

Cognitive Enhancement Through Transcranial Laser Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851173
• Other study ID #: 2015-09-0018
• Status: Completed
• Phase: Phase 2
• Start date: February 21, 2016
• Est. completion date: April 30, 2020

Study information

• Verified date: September 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Healthy Participants
• Mild Cognitive Impairment

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychomotor Vigilance Task (PVT)	The psychomotor vigilance task (PVT) is a sustained-attention, reaction-timed task that measures the consistency with which subjects respond to a visual stimulus.	Time 1 represents PVT performance (reaction time in msec) at baseline, Time 2 represents PVT performance (reaction time in msec) six weeks later.
Secondary	Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task	The outcome represents a score on a scale - brain activation in response to a working memory task (t-statistic). The range is approximately -15 to +15. Positive scores reflect greater engagement of working memory brain regions and better performance.	T1 represents score at baseline; T2 represents follow-up score, 6 weeks later
Secondary	Working Memory (2 Back Task)	2Back task performance (%Correct)	T1 represents 2back % Correct at baseline; T2 represents 2back % Correct 6 weeks later
Secondary	Working Memory (2 Back Task)	2Back task performance (Reaction Time in msec)	T1 represents 2back Reaction Time (RT) in msec at baseline; T2 represents Reaction Time (RT) in msec 6 weeks later