AgingNCT02582593
Revitalize Cognition: Near Infrared Stimulation in Older Adults
A study testing MedX 1116 Rehab Console in people with Aging, run by University of Florida at 2 sites in United States.
Trial summary
Changes in mood and cognition are common in older adulthood. Some studies have suggested that transcranial application of near-infrared (NIR) light may have enhancing effects on cognitive and mood status in young adults and individuals with traumatic brain injury. This effect has not been examined in older adults. Read more about this study
- Who is it for?
- Ages 62 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- MedX 1116 Rehab Console
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Dec 2015to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 62 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 62 years or above
- Able to provide informed consent and perform cognitive and mood measures on a computer
- Willingness to be randomized to Sham or Real intervention
- Can devote 2 weeks to the intervention, and additional time for pre and post testing
- 8th grade education and ability to read on 8th grade level based on scores on the Wechsler Test of Adult Reading (WTAR) or the Wide Range Achievement Test-IV (WRAT-IV); or a reading test at 14 pt. text
- On stable doses of major medications; Since some older adults with memory complaints may be prescribed acetylcholinererase inhibitors or related medications by their primary care physicians (i.e., donepezil, rivastigmine, galantaominhe, memantime, or other potential memory-enhancing agent(s), we will not exclude them as long as they have been on stable medications for at least two months and plan to continue this medication during study participation.
- Willingness to allow a study partner (spouse, family member, friend) to answer questions about their cognitive, mood, and other behaviors
Who cannot join
- Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental cognitive tasks or neuropsychological assessment
- Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate to severe kidney or liver disease)
- Previous major strokes or other known significant brain abnormalities or diseases affecting cognition (i.e., multiple sclerosis, seizure disorder, brain surgery, moderate TBI, etc.). No history of brain surgery. Exceptions are a diagnosis of Parkinson's disease for the PD subgroup.
- Evidence of potential dementia (e.g., scores < 24 on the Mini Mental State Exam (MMSE), or < 20 on the Montreal Cognitive Assessement (MoCA), or less than 5th percentile on the Dementia Rating Scale-2 (DRS-2)
- Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months. This will be assessed using the Mental Health Screen v.3 (Carroll \& McGinley), a modification of the Structured Clinical Interview for DSM-IV psychiatric disorders. We are not excluding individuals who are taking antidepressants or anti-anxiety medications, however, use of antidepressants and anxiolytics will be recorded and data will be analyzed in post-hoc analyses
- Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
Show all 9Show fewer
- Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention
- Diagnosis of cancer
- Previous participation in a cognitive training study within the last 3 months or current involvement in another study at VITAL or ReVITALIZE, or another study involving cognitive training or intervention at the time of participation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607
The Village Retirement Community
Gainesville, Florida, 32653
About this study
Official title: Revitalize Cognition: A Proof of Concept Study Using Transcranial Near Infrared Stimulation in Older Adults
Changes in mood and cognition are common in older adulthood. Some studies have suggested that transcranial application of near-infrared (NIR) light may have enhancing effects on cognitive and mood status in young adults and individuals with traumatic brain injury. This effect has not been examined in older adults. This study will involve a randomized sham-controlled trial to learn whether NIR stimulation improves cognition and mood in older adults, relative to sham treated controls.
Aim 4 of this study (Parkinson Specific) is registered separately under NCT06688357
Read the detailed description
There is a dearth of clinically meaningful treatment options at this point in time for individuals who are at increased risk for transitioning to dementia, particularly those with the amnestic variant of mild cognitive impairment (aMCI). While waiting for causative cures and preventive approaches, investigators are faced with the task of identifying modifying therapies that might alter the course or slow down the transition from normal cognition to MCI to dementia.
The proposed study hopes to contribute to this mission by testing the viability of a different type of intervention, one involving transcranial delivery of near-infrared (NIR) wavelengths (808-904nm). Near-infrared stimulation is safe, non-invasive and appears to improve mitochondrial function by promoting increased production of intracellular adenosine triphosphate (ATP) and possibly improved blood flow. Perhaps most compelling are recent findings of reduced beta-amyloid and neurofibrillary tangles in transgenic Alzheimer's mouse models after exposure to real vs sham transcranial NIR stimulation. Preliminary human involving traumatic brain injury (TBI), stroke, and young adult populations have also been promising in terms of positive effects of NIR on cognition.
The overall goal of the present study is to learn whether this unconventional NIR stimulation approach has potential for improving cognition in older adults. To do so, investigators will conduct a randomized sham controlled pilot trial. The intervention will involve six sessions, over a 2-week period in which real or sham stimulation is transcranially applied using a delivery system that has been FDA-approved as a nonsignificant risk since 2003. Researchers hope to learn whether NIR stimulation, relative to sham, has positive effects on cognition and mood in older adults.
- Conditions
- Aging
- Being tested
- MedX 1116 Rehab Console, Sham MedX 1116 Rehab Console
- Keywords
- Cognitive Aging, Neuromodulation, Low Level Light Therapy, Near Infrared Light, Neurostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedX 1116 Rehab ConsoleDevice
Also called Photobiomodulation, Low Level Light Therapy, Transcranial Near Infrared Stimulation
This intervention makes use of transcranially applied near infrared light using light emitting diodes. Near infrared light will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held.
Sham MedX 1116 Rehab ConsoleDevice
Also called Placebo
This intervention makes use of sham transcranially applied near infrared light using light emitting diodes. Light emitting diodes (but not near-infrared light) will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held.
| Study group | Role | What they receive |
|---|---|---|
| Older Adult Group NIR | Active comparator | Transcranial Near Infrared Stimulation for cognitively normal participants who will attend a total of 6 treatment sessions over a two week period. During each session, stimulation via light emitting diode clusters will occur for a total of 60 minutes. Four light emitting diode (LED) clusters will be applied in 3 distinct configurations. There will be 20 minutes of stimulation at each of these 3 configurations. Each configuration will target 4 sites, for a total of 12 sites over the course of the 60 minute session. The power density used will be 500 milliwatts (mW) with a cumulative fluence (energy density) of 312 Joules/cm2 (26 J/cm2 applied at 12 sites). It is estimated that approximately 6 Joules/cm2 will reach the cortex with each daily treatment. Receives: Device: MedX 1116 Rehab Console |
| Older Adult Group - Sham | Sham comparator | Cognitively Normal Participants in the sham control group will undergo identical procedures as the intervention group - screening, baseline testing, and LED cluster placement procedures. However, during the near infrared (NIR) session, the MedX console will not be turned on and no active stimulation will be applied. Receives: Device: Sham MedX 1116 Rehab Console |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Examiner Battery, Executive Composite Changes From Baseline to Post-testing
Computer-based battery of executive functioning tests which yields a total or "composite" score to represent global executive functioning. Executive composite scores can range from -3.0 to 3.0, with higher scores corresponding to better executive functioning, and negative scores indicating impairment. A change score will be calculated by subtracting the baseline scores from the post-test scores.
Measured: Change in baseline to approximately week 3
Secondary outcomes (3)
Composite Learning-Retention Score From ARENA Task
ARENA is a task of spatial memory and navigation that is a human analogue to the Morris water maze used in animal studies. Participants learn to navigate to a hidden target location relying on spatial cues in a simulated environment over a series of 8 learning trials and a final retention trial. The final ARENA outcome is an Overall Composite z-score combining learning and retention metrics as follows: [-Learning z-score + Retention z-score]/2. The learning z-score is based on two metrics (path length to target, time to reach target) that are converted to z-scores and averaged over the 8 learning trials. The retention z-score is based on percent time spent in the target quadrant during the retention trial. The Learning and Retention z-scores are combined to create a single final Arena Composite outcome. Higher composite scores reflect better memory performance. A change score is calculated by subtracting the Baseline Composite score from the post-test Composite Score
Measured: Change in baseline to approximately week 3
NIH Toolbox Emotion Psychological Wellbeing Scale Changes From Baseline to Post-testing
The Psychological Wellbeing Scale from the NIH Toolbox Emotion module Wellbeing Scale results in T-scores (mean=50, SD=10) for categories such as positive affect, life satisfaction, and meaning and purpose. Scores below 40 indicate low levels of wellbeing and scores above 60 indicating high levels of wellbeing. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
Measured: Change in baseline to approximately week 3 (Post - Baseline)
NIH Toolbox Emotion Negative Affect Scale Changes 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 and scores above 60 indicate high levels of negative affect. Change scores will be calculated by subtracting the baseline scores from the post-test scores.
Measured: Change from baseline to approximately week 3 (Post Intervention - Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start18 Dec 2015
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, sham controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Ed and Ethel Moore Alzheimer's Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Dawn Bowers, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582593
- Sponsor's protocol ID
- IRB201400128
- Other IDs
- 6AZ15, PF-IMP-1938
- Status last verified
- Jan 2025
- First submitted
- 16 Oct 2015
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revitalize Cognition: A Proof of Concept Study Using Transcranial Near Infrared Stimulation in Older Adults
- ClinicalTrials.gov ID
- NCT02582593
- Acronym / sponsor ID
- IRB201400128
- Conditions
- Aging
- Keywords
- Cognitive Aging, Neuromodulation, Low Level Light Therapy, Near Infrared Light, Neurostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Ed and Ethel Moore Alzheimer's Disease Research Program
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Posted 19 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Changes in mood and cognition are common in older adulthood. Some studies have suggested that transcranial application of near-infrared (NIR) light may have enhancing effects on cognitive and mood status in young adults and individuals with traumatic brain injury. This effect has not been examined in older adults. This study will involve a randomized sham-controlled trial to learn whether NIR stimulation improves cognition and mood in older adults, relative to sham treated controls.
Aim 4 of this study (Parkinson Specific) is registered separately under NCT06688357
Detailed description
There is a dearth of clinically meaningful treatment options at this point in time for individuals who are at increased risk for transitioning to dementia, particularly those with the amnestic variant of mild cognitive impairment (aMCI). While waiting for causative cures and preventive approaches, investigators are faced with the task of identifying modifying therapies that might alter the course or slow down the transition from normal cognition to MCI to dementia.
The proposed study hopes to contribute to this mission by testing the viability of a different type of intervention, one involving transcranial delivery of near-infrared (NIR) wavelengths (808-904nm). Near-infrared stimulation is safe, non-invasive and appears to improve mitochondrial function by promoting increased production of intracellular adenosine triphosphate (ATP) and possibly improved blood flow. Perhaps most compelling are recent findings of reduced beta-amyloid and neurofibrillary tangles in transgenic Alzheimer's mouse models after exposure to real vs sham transcranial NIR stimulation. Preliminary human involving traumatic brain injury (TBI), stroke, and young adult populations have also been promising in terms of positive effects of NIR on cognition.
The overall goal of the present study is to learn whether this unconventional NIR stimulation approach has potential for improving cognition in older adults. To do so, investigators will conduct a randomized sham controlled pilot trial. The intervention will involve six sessions, over a 2-week period in which real or sham stimulation is transcranially applied using a delivery system that has been FDA-approved as a nonsignificant risk since 2003. Researchers hope to learn whether NIR stimulation, relative to sham, has positive effects on cognition and mood in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, sham controlled
| Arm | Type | Receives |
|---|---|---|
| Older Adult Group NIR | Active comparator | Device: MedX 1116 Rehab ConsoleTranscranial Near Infrared Stimulation for cognitively normal participants who will attend a total of 6 treatment sessions over a two week period. During each session, stimulation via light emitting diode clusters will occur for a total of 60 minutes. Four light emitting diode (LED) clusters will be applied in 3 distinct configurations. There will be 20 minutes of stimulation at each of these 3 configurations. Each configuration will target 4 sites, for a total of 12 sites over the course of the 60 minute session. The power density used will be 500 milliwatts (mW) with a cumulative fluence (energy density) of 312 Joules/cm2 (26 J/cm2 applied at 12 sites). It is estimated that approximately 6 Joules/cm2 will reach the cortex with each daily treatment. |
| Older Adult Group - Sham | Sham comparator | Device: Sham MedX 1116 Rehab ConsoleCognitively Normal Participants in the sham control group will undergo identical procedures as the intervention group - screening, baseline testing, and LED cluster placement procedures. However, during the near infrared (NIR) session, the MedX console will not be turned on and no active stimulation will be applied. |
Who may qualify
- Ages
- 62 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 62 years or above
- Able to provide informed consent and perform cognitive and mood measures on a computer
- Willingness to be randomized to Sham or Real intervention
- Can devote 2 weeks to the intervention, and additional time for pre and post testing
- 8th grade education and ability to read on 8th grade level based on scores on the Wechsler Test of Adult Reading (WTAR) or the Wide Range Achievement Test-IV (WRAT-IV); or a reading test at 14 pt. text
Key exclusion criteria (9 listed)
- Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental cognitive tasks or neuropsychological assessment
- Unstable and uncontrolled medical conditions (metabolic encephalopathy, HIV, moderate to severe kidney or liver disease)
- Previous major strokes or other known significant brain abnormalities or diseases affecting cognition (i.e., multiple sclerosis, seizure disorder, brain surgery, moderate TBI, etc.). No history of brain surgery. Exceptions are a diagnosis of Parkinson's disease for the PD subgroup.
- Evidence of potential dementia (e.g., scores < 24 on the Mini Mental State Exam (MMSE), or < 20 on the Montreal Cognitive Assessement (MoCA), or less than 5th percentile on the Dementia Rating Scale-2 (DRS-2)
- Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months. This will be assessed using the Mental Health Screen v.3 (Carroll \& McGinley), a modification of the Structured Clinical Interview for DSM-IV psychiatric disorders. We are not excluding individuals who are taking antidepressants or anti-anxiety medications, however, use of antidepressants and anxiolytics will be recorded and data will be analyzed in post-hoc analyses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedX 1116 Rehab ConsoleAlso: Photobiomodulation, Low Level Light Therapy, Transcranial Near Infrared StimulationThis intervention makes use of transcranially applied near infrared light using light emitting diodes. Near infrared light will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held. | Device | Older Adult Group NIR |
| Sham MedX 1116 Rehab ConsoleAlso: PlaceboThis intervention makes use of sham transcranially applied near infrared light using light emitting diodes. Light emitting diodes (but not near-infrared light) will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held. | Device | Older Adult Group - Sham |
Primary outcome
NIH Examiner Battery, Executive Composite Changes From Baseline to Post-testing
Time frame: Change in baseline to approximately week 3
Computer-based battery of executive functioning tests which yields a total or "composite" score to represent global executive functioning. Executive composite scores can range from -3.0 to 3.0, with higher scores corresponding to better executive functioning, and negative scores indicating impairment. A change score will be calculated by subtracting the baseline scores from the post-test scores.
3 secondary outcomes
Composite Learning-Retention Score From ARENA Task
Time frame: Change in baseline to approximately week 3
NIH Toolbox Emotion Psychological Wellbeing Scale Changes From Baseline to Post-testing
Time frame: Change in baseline to approximately week 3 (Post - Baseline)
NIH Toolbox Emotion Negative Affect Scale Changes From Baseline to Post-testing
Time frame: Change from baseline to approximately week 3 (Post Intervention - Baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Bowers, Ph.D. principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedX 1116 Rehab Console in people with Aging, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Examiner Battery, Executive Composite Changes From Baseline to Post-testing (time frame: Change in baseline to approximately week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.