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| ID | Type | Description | Link |
|---|---|---|---|
| 5KL2TR001429 | U.S. NIH Grant/Contract | View source | |
| 1K01AG050707-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This study will investigate whether transcranial direct current stimulation enhances the effects of cognitive training in healthy older adults.
The current study will investigate methods for enhancing cognitive training effects in healthy older adults by employing a combination of interventions facilitating neural plasticity and optimizing readiness for learning. Adults over the age of 65 represent the fastest growing group in the US population. As such, age-related cognitive decline represents a major concern for public health. Recent research suggests that cognitive training in older adults can improve cognitive performance, with effects lasting up to 10 years. However, these effects are typically limited to the tasks trained, with little transfer to other cognitive abilities or everyday skills. A pilot 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 enhances neural plasticity when paired with a training task. We will compare changes in cognitive and brain function resulting from CT and CT combined with tDCS using a comprehensive neurocognitive, clinical, and multimodal neuroimaging assessment of brain structure, function, and metabolic state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training + Active tDCS | Experimental | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation. |
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| Cognitive Training + Sham tDCS | Sham Comparator | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham Stimulation | Device | Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in NIH Toolbox Fluid Cognition Composite Score | The NIH Toolbox is a battery of neurocognitive tests created by the National Institute on Aging as a comprehensive measure of cognitive function. We used the change from baseline to two week post test in the NIH Toolbox Fluid Cognition Composite Score (FCC) to assess outcome. The uncorrected standard score of the FCC was used. The FCC is derived by averaging the standard scores of the NIH Toolbox Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting, and Pattern Comparison tests and then deriving standard scores based on this new distribution. The uncorrected standard score is on a scale of mean = 100, standard deviation = 15. Higher positive scores mean a greater improvement at the post test. Difference scores ranged from a minimum of -7 to a maximum of 19. FCC scores ranged from a minimum of 73 to a maximum of 112 in this sample. On a population level percentiles are reported from a minimum score of 59 to a maximum of 140, covering 99.3% of the population. | baseline up to two week post test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam J Woods, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| McKnight Brain Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31998111 | Derived | Nissim NR, O'Shea A, Indahlastari A, Kraft JN, von Mering O, Aksu S, Porges E, Cohen R, Woods AJ. Effects of Transcranial Direct Current Stimulation Paired With Cognitive Training on Functional Connectivity of the Working Memory Network in Older Adults. Front Aging Neurosci. 2019 Dec 16;11:340. doi: 10.3389/fnagi.2019.00340. eCollection 2019. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Training + Active tDCS | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation. Transcranial Direct Current Stimulation: Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. |
| FG001 | Cognitive Training + Sham tDCS | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation. Sham Stimulation: Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Training + Active tDCS | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation. Transcranial Direct Current Stimulation: Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in NIH Toolbox Fluid Cognition Composite Score | The NIH Toolbox is a battery of neurocognitive tests created by the National Institute on Aging as a comprehensive measure of cognitive function. We used the change from baseline to two week post test in the NIH Toolbox Fluid Cognition Composite Score (FCC) to assess outcome. The uncorrected standard score of the FCC was used. The FCC is derived by averaging the standard scores of the NIH Toolbox Flanker, Dimensional Change Card Sort, Picture Sequence Memory, List Sorting, and Pattern Comparison tests and then deriving standard scores based on this new distribution. The uncorrected standard score is on a scale of mean = 100, standard deviation = 15. Higher positive scores mean a greater improvement at the post test. Difference scores ranged from a minimum of -7 to a maximum of 19. FCC scores ranged from a minimum of 73 to a maximum of 112 in this sample. On a population level percentiles are reported from a minimum score of 59 to a maximum of 140, covering 99.3% of the population. | 1 participant in the Cognitive Training + Sham tDCS group listed in the baseline characteristics section withdrew prior to post test, reducing the number from 16 to 15 in this group. | Posted | Mean | Standard Deviation | units on a scale | baseline up to two week post test |
Adverse event data were recorded between randomization to intervention and three month follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Training + Active tDCS | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation. Transcranial Direct Current Stimulation: Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization (High blood pressure) | Cardiac disorders | Non-systematic Assessment | Participant was hospitalized due to uncontrolled high blood pressure. Participant reported history of high blood pressure. Hospitalization occurred 89 days post intervention completion and was judged unrelated to the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Woods | University of Florida | 352-294-5842 | ajwoods@phhp.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2019 | Jan 31, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Transcranial Direct Current Stimulation | Device | Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. |
|
|
| Gainesville |
| Florida |
| 32611 |
| United States |
| BG001 | Cognitive Training + Sham tDCS | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation. Sham Stimulation: Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NIH toolbox fluid cognition uncorrected standard score | Scale Name: National Institutes of Health Fluid Cognition Uncorrected Standard Score. Measures constructs of executive function, attention, episodic memory, processing speed and working memory. Scores from the flanker test, list sorting working memory test, dimensional change card sort test, pattern comparison processing speed test, and picture sequence memory test are averaged to create the fluid composite. Higher values represent better fluid cognition. In this sample, fluid cognition scores ranged from a minimum value of 62 to a maximum value of 111. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Cognitive Training + Active tDCS | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo active transcranial direct current stimulation. Transcranial Direct Current Stimulation: Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes. |
| OG001 | Cognitive Training + Sham tDCS | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation. Sham Stimulation: Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. |
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Cognitive Training + Sham tDCS | Participants will undergo up to 10 hours of cognitive training. Cognitive training will involve computerized games that stress elements of cognition. The group will undergo sham transcranial direct current stimulation. Sham Stimulation: Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes. | 0 | 16 | 1 | 16 | 0 | 16 |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |