Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| OCR18061 | Other Identifier | University of Florida | |
| PRO00020250 | Other Identifier | UFIRST |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| McKnight Brain Research Foundation | UNKNOWN |
| University of Arizona | OTHER |
Not provided
Not provided
Not provided
The current study will test whether age-related cognitive and mood changes in older adults and those will be affected by near infrared (NIR) stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.
This is a multi-site pilot study of the efficacy of NIR stimulation for enhancing cognition and mood in nondemented older adults. Sites include the University of Florida and University of Arizona. Prior research suggests that NIR exposure may be neuroprotective and increases energy available to neurons. The current study will test whether age-related cognitive and mood changes in older adults will be affected by near infrared (NIR) stimulation.
The study team will randomize older adults into treatment groups and evaluate neuroimaging and cognitive outcome measures, before and after a 12-week intervention involving transcranial and intranasal NIR. The protocol will involve both " lab" and " home-based" NIR stimulation. The overall hypothesis, drawn from previous literature, is that exposure to NIR stimulation will have positive effects on brain health and will result in better cognitive and mood performance.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIR -Older Adult | Active Comparator | Older adult participants receive the Medx Console System and the Vielight 810 intranasal stand alone unit. These interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week. |
|
| No Dose NIR-Older Adult | Sham Comparator | Older adult participants receive the sham Medx Console System and the sham Vielight 810 intranasal stand alone unit, since the devices deliver no near infrared light. These sham interventions occur during 16 lab sessions (1.5 hours each) during an 12 week period, plus daily 25 minute 'at home' intranasal stimulation interventions, 4 days each week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medx Console System | Device | This intervention delivers near infrared (NIR) light using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| ARENA, learning and memory change from baseline to post-testing | Spatial navigation and memory task yields a score consisting of percent time spent in the target quadrant during the probe trial. | Baseline to one-week post intervention (approx Week 14) |
| Measure | Description | Time Frame |
|---|---|---|
| NIH Examiner, Verbal Fluency Domain Score change from baseline | The Verbal Fluency domain from the NIH Examiner involves speeded production of letter and semantic cued words. Verbal fluency composite score can range from -3.0 to 3.0, with higher scores corresponding to better fluency performance and negative scores indicating impairment. A change score will be calculated by subtracting the baseline scores from the post test scores. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawn Bowers, Ph.D. | Contact | 352-273-5270 | dawnbowers@Phhp.ufl.edu | |
| Adam Woods, Ph.D. | Contact | 352-294-5842 | ajwoods@phhp.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dawn Bowers, Ph.D. | University of Florida | Principal Investigator |
| Adam Woods, Ph.D. | University of Florida | Principal Investigator |
| Gene Alexander, Ph.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85721 | United States | |
| University of Florida |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
Not provided
Not provided
This is a blinded parallel group sham controlled pilot trial, with half the participants in each group randomized to the real NIR treatment and half to the sham treatment condition.
Not provided
Not provided
Research assistants who administer pre and post measures will be masked, as well as participants who receive the intervention.
|
| Sham Medx Console System | Device | This intervention uses sham application of near infrared light (NIR) using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks. |
|
| Vielight 810 intranasal stand alone unit | Device | Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week. |
|
| Sham Vielight 810 intranasal stand alone unit | Device | Daily at home intranasal "sham" NIR stimulation sessions, 25 minutes in duration, 4 days each week. |
|
| Change in baseline to one-week post intervention (approx Week 14) |
| NIH Examiner, Working Memory Domain score change from baseline | Computer based battery of working memory tasks that yields a composite score based on Dot Counting total score and d-prime measures from the N-back task. Composite score ranges from -3.0 to 3.0, with higher scores corresponding to better working memory performance. A change score will be calculated by subtracting the baseline scores from the post test scores. | Change in baseline to one-week post intervention (approx Week 14) |
| NIH Examiner, Cognitive Control Domain score change from baseline to post-testing | The Cognitive Control domain from the NIH Examiner yields a composite score based on individual scores from the Flanker task, the Continuous Performance task, and the Set-Shifting task. Composite score ranges from -3.0 to 3.0, with higher scores corresponding to better cognitive control performance. A change score will be calculated by subtracting the baseline scores from the post test scores. | Change in baseline to one-week post intervention (approx Week 14) |
| NIH Toolbox Emotion Negative Affect Scale change from baseline to post-testing | The Negative Affect Scale from the NIH Toolbox Emotion module results in T-scores (mean=50, SD=10) for categories such as anger, sadness, and apathy. Scores below 40 indicate low levels of negative affect. Change scores will be calculated by subtracting the baseline scores from the post-test scores. | Baseline to one-week post-intervention (approx Week 14) |
| NIH Toolbox Emotion-Psychological Well Being Scale change from baseline | The Psychological Well-being Scale from the NIH Toolbox Emotion module results in T-scores (mean=50, SD=10) for categories such general life satisfaction, meaning and purpose, and positive affect. Scores below 40 indicate low levels of positive affect. Change scores will be calculated by subtracting the baseline scores from the post-test scores. | Change in baseline to one-week post intervention (approx Week 14) |
| University of Arizona |
| Principal Investigator |
| Recruiting |
| Gainesville |
| Florida |
| 32611 |
| United States |