An interventional study of Cognitive Training and tDCS (active stimulation) in Aging, sponsored by University of Florida. Completed at 3 sites in United States. Open to participants aged 65 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
A two-phase adaptive randomized clinical trial will examine the individual and combined impact of pairing cognitive training with transcranial direct current stimulation (tDCS). tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and could enhance neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and ET combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state. Functional magnetic resonance imaging (FMRI) will be used to assess brain response during working memory, attention, and memory encoding; the active cognitive abilities trained by CT. Proton magnetic resonance spectroscopy (MRS) will assess cerebral metabolites, including GABA concentrations sensitive to neural plasticity. We hypothesize that: 1) tDCS will enhance neurocognitive function, brain function, and functional outcomes from CT, with combined CT and tDCS providing the most benefit; 2) Effects of tDCS on CT will be maintained up to 12 months following training, and 3) Neuroimaging biomarkers of cerebral metabolism, neural plasticity (GABA concentrations) and functional brain response (FMRI) during resting vs. active cognitive tasks will predict individual response to tDCS.
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This arm receives cognitive training combined with active tDCS.
Behavioral: Cognitive Training · Device: tDCS (active stimulation)
This arm receives cognitive training combined with sham tDCS.
Behavioral: Cognitive Training · Device: tDCS (sham stimulation)
This arm receives educational training combined with active tDCS.
Device: tDCS (active stimulation) · Behavioral: Educational Training
This arm receives educational training combined with sham tDCS.
Device: tDCS (sham stimulation) · Behavioral: Educational Training
Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
Improvement in Cognitive Ability.
Composite measure of cognitive ability as defined by NIH toolbox fluid cognition fully corrected T-score. Minimum change = -13, Maximum change = 26. Higher scores mean a better outcome. The minimum and maximum for Cognitive Training + Active Stimulation, Cognitive Training + Sham Stimulation, Educational Training + Active Stimulation and Educational Training + Sham Stimulation are (-13, 20) and (-10, 26), respectively. This outcome is measured for the participants who received cognitive training, including both Phase I and Phase II participants, N=334 (Phase I N=42, Phase II N=292).
Time frame: Change from baseline to post assessment (3 months).
Phase I POSIT BrainHQ Cognitive Training Composite Performance Measure.(Phase I POSIT Z-Score)
POSIT BrainHQ Cognitive Training Composite Performance measure involves performance on the 8 selected cognitive training tasks set to the medium difficulty level and provides a measure of proximal performance on cognitive training tasks central to the cognitive training condition. The higher score indicates better performance. The range of POSIT Z-Score at 3-month is -1.04 to 1.75. the minimum and maximum for Cognitive training group and Education training group are (-0.24, 1.75) and (-1.04, 1.39), respectively.
Time frame: Baseline to post assessment (3 months).
Participant flow is reported with three periods. Period 1 includes all randomized participants (combined Phase I and Phase II). Period 2 contains only the Phase I participants. Period 3 contains only the Phase II participants. In Phase II the two education training arms were eliminated, hence the allocation of 0 to those groups. Participants who were enrolled in Phase I education training were not randomized again in Phase II (there is no crossover).
| Milestone | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation |
|---|---|---|---|---|
| Started | 168 | 166 | 23 | 22 |
| Completed | 126 | 127 | 23 | 18 |
| Not completed | 42 | 39 | 0 | 4 |
| Withdrew: Physician decision | 18 | 16 | 0 | 1 |
| Withdrew: Withdrawal by subject | 20 | 17 | 0 | 3 |
| Withdrew: Covid-19 lockdown, no reason specified | 4 | 5 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
| Milestone | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation |
|---|---|---|---|---|
| Started | 21 | 21 | 23 | 22 |
| Completed | 19 | 20 | 23 | 18 |
| Not completed | 2 | 1 | 0 | 4 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 | 0 | 3 |
| Milestone | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation |
|---|---|---|---|---|
| Started | 147 | 145 | 0 | 0 |
| Completed | 107 | 107 | 0 | 0 |
| Not completed | 40 | 38 | 0 | 0 |
| Withdrew: Physician decision | 18 | 16 | 0 | 0 |
| Withdrew: Withdrawal by subject | 18 | 16 | 0 | 0 |
| Withdrew: Covid-19 lockdown, no reason specified | 4 | 5 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 |
Composite measure of cognitive ability as defined by NIH toolbox fluid cognition fully corrected T-score. Minimum change = -13, Maximum change = 26. Higher scores mean a better outcome. The minimum and maximum for Cognitive Training + Active Stimulation, Cognitive Training + Sham Stimulation, Educational Training + Active Stimulation and Educational Training + Sham Stimulation are (-13, 20) and (-10, 26), respectively. This outcome is measured for the participants who received cognitive training, including both Phase I and Phase II participants, N=334 (Phase I N=42, Phase II N=292).
| units on a scale | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation |
|---|---|---|
| Improvement in Cognitive Ability. | 4.7 ± 6.5 | 4.5 ± 6.1 |
POSIT BrainHQ Cognitive Training Composite Performance measure involves performance on the 8 selected cognitive training tasks set to the medium difficulty level and provides a measure of proximal performance on cognitive training tasks central to the cognitive training condition. The higher score indicates better performance. The range of POSIT Z-Score at 3-month is -1.04 to 1.75. the minimum and maximum for Cognitive training group and Education training group are (-0.24, 1.75) and (-1.04, 1.39), respectively.
| units on a scale | Cognitive Training | Education Training |
|---|---|---|
| Phase I POSIT BrainHQ Cognitive Training Composite Performance Measure.(Phase I POSIT Z-Score) | 0.95 ± 0.41 | -0.06 ± 0.47 |
Collected over The adverse events were collected over an approximate one year period. They were collected from study enrollment until the 1 year followup visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cognitive Training + Active Stimulation | 0/168 (0%) | 16/168 (9.5%) | 69/168 (41.1%) |
| Cognitive Training + Sham Stimulation | 0/166 (0%) | 19/166 (11.4%) | 75/166 (45.2%) |
| Educational Training + Active Stimulation | 0/23 (0%) | 4/23 (17.4%) | 12/23 (52.2%) |
| Educational Training + Sham Stimulation | 0/22 (0%) | 5/22 (22.7%) | 12/22 (54.5%) |
| Event | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation |
|---|---|---|---|---|
| Cat biteInfections and infestations | 0/168 | 0/166 | 0/23 | 1/22 |
| Chest PainCardiac disorders | 1/168 | 1/166 | 0/23 | 1/22 |
| HerniaGastrointestinal disorders | 0/168 | 0/166 | 0/23 | 1/22 |
| Pulmonary EmbolismVascular disorders | 0/168 | 0/166 | 0/23 | 1/22 |
| Skin cancer spot removalNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/168 | 0/166 | 1/23 | 1/22 |
| Transient ischemic attackVascular disorders | 1/168 | 0/166 | 0/23 | 1/22 |
| Allergic reactionSkin and subcutaneous tissue disorders | 0/168 | 0/166 | 1/23 | 0/22 |
| Cyst removalSkin and subcutaneous tissue disorders | 1/168 | 0/166 | 1/23 | 0/22 |
| FallGeneral disorders | 0/168 | 2/166 | 1/23 | 0/22 |
| Torn arteryVascular disorders | 0/168 | 0/166 | 1/23 | 0/22 |
| Event | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation |
|---|---|---|---|---|
| Skin cancer spot removalSurgical and medical procedures | 19/168 | 24/166 | 4/23 | 3/22 |
| Urinary tract infectionRenal and urinary disorders | 3/168 | 9/166 | 1/23 | 3/22 |
| ArthritisMusculoskeletal and connective tissue disorders | 8/168 | 8/166 | 0/23 | 2/22 |
| Migraine headacheNervous system disorders | 6/168 | 10/166 | 1/23 | 1/22 |
| Cataract surgerySurgical and medical procedures | 10/168 | 6/166 | 1/23 | 0/22 |
| Anxiety and DepressionPsychiatric disorders | 2/168 | 2/166 | 0/23 | 1/22 |
| Bladder infectionRenal and urinary disorders | 0/168 | 0/166 | 0/23 | 1/22 |
| ColonoscopySurgical and medical procedures | 3/168 | 2/166 | 0/23 | 1/22 |
| Hearing impairmentEar and labyrinth disorders | 1/168 | 0/166 | 0/23 | 1/22 |
| High Blood PressureCardiac disorders | 6/168 | 1/166 | 0/23 | 1/22 |
The study is a 2-phase adaptive design study. After first phase, 2 education arms were dropped. all participants were randomly assigned to 2 cognitive training groups in Phase II.
| Age, Continuous(years) | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation | Total |
|---|---|---|---|---|---|
| Mean | 71.5 ± 5.4 | 71.5 ± 4.8 | 70.0 ± 5.1 | 73.1 ± 4.7 | 71.5 ± 5.1 |
| Sex: Female, Male(Participants) | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation | Total |
|---|---|---|---|---|---|
| Female | 104 | 111 | 10 | 11 | 236 |
| Male | 64 | 55 | 13 | 11 | 143 |
| Ethnicity (NIH/OMB)(Participants) | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 14 | 8 | 1 | 2 | 25 |
| Not Hispanic or Latino | 154 | 158 | 22 | 20 | 354 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 5 | 1 | 0 | 9 |
| Asian | 0 | 3 | 1 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 0 | 1 |
| Black or African American | 11 | 8 | 0 | 2 | 21 |
| White | 146 | 148 | 20 | 18 | 332 |
| More than one race | 5 | 2 | 0 | 2 | 9 |
| Unknown or Not Reported | 3 | 0 | 0 | 0 | 3 |
| Region of Enrollment(participants) | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation | Total |
|---|---|---|---|---|---|
| United States | 168 | 166 | 23 | 22 | 0 |
| Years of Education(years) | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation | Total |
|---|---|---|---|---|---|
| Mean | 16.3 ± 2.3 | 16.4 ± 2.4 | 16.7 ± 2.1 | 15.6 ± 2.4 | 16.3 ± 2.4 |
| MOCA Total Score(units on a scale) | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation | Total |
|---|---|---|---|---|---|
| Mean | 26.7 ± 2.0 | 26.8 ± 1.9 | 26.9 ± 1.7 | 26.1 ± 2.1 | 26.7 ± 1.9 |
| Average POSIT z-score:(z-score) | Cognitive Training + Active Stimulation | Cognitive Training + Sham Stimulation | Educational Training + Active Stimulation | Educational Training + Sham Stimulation | Total |
|---|---|---|---|---|---|
| Mean | -0.18 ± 0.44 | -0.20 ± 0.46 | -0.11 ± 0.47 | -0.44 ± 0.55 | -0.20 ± 0.46 |
1 further baseline measures are reported on the registry.
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