Phase 2
N=91
Cognitive Enhancement Through Transcranial Laser Therapy
Healthy Participants · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02851173 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Psychomotor Vigilance Task (PVT) — 341.89; 344.09; 331.11; 330.75 msec — p=0.79
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LLLT (Device); Placebo (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- University of Texas at Austin
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Psychomotor Vigilance Task (PVT) |
341.89; 344.09; 331.11; 330.75; 329.76; 339.81 | 0.79 |
| SECONDARY Brain Blood Oxygen Level Dependent Response to Working Memory (2Back) Task |
2.47; 3.00; 2.51; 3.39; 2.90; 2.67 | 0.22 |
| SECONDARY Working Memory (2 Back Task) |
1289.19; 1173.98; 1202.89; 1035.05 | 0.72 |
| SECONDARY Working Memory (2 Back Task) |
1289.19; 1173.98; 1202.89; 1035.05 | 0.72 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02851173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.