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Individuals aged 55 and older may experience negative effects of cognitive decline. The proposed research seeks to evaluate the benefits of different types of interventions: reasoning training following transcranial direct current stimulation (tDCS) and reasoning training following sham transcranial direct current stimulation (tDCS) on frontal- lobe mediated cognitive measures of executive control in adults with memory complaints, in the absence of dementia.
The purpose of this study is to evaluate the impact of reasoning training on individuals with complaints of changes in memory or thinking in the absence of dementia, when combined with transcranial current stimulation (tDCS). The reasoning training being studied is a strategy based program where individuals are taught strategies designed to engage the frontal lobes. Participants will randomly be placed into one of two groups (1) reasoning training following transcranial current stimulation (tDCS) as compared to (2) reasoning training following sham tDCS. The study will be done with adults between the ages of 50 and 80 with consistent memory complaints or lower baseline performance on memory measures. The primary hypothesis is that individuals receiving tDCS prior to brain training will have a stronger response to brain training than those in the sham tDCS group. Response to training will be measured by improved cognitive function and neural changes as measured by neuropsychological testing, MRI, and EEG. MRI will be used to evaluate the impact of reasoning training on brain blood flow, structure and function, and to measure changes in brain energy metabolism and electroencephalogram (EEG) to evaluate intervention outcomes. The reasoning training program will be conducted in small groups at the Center for BrainHealth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS+Training | Experimental | This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks |
|
| Sham tDCS+training | Sham Comparator | This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS | Device | Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in California Verbal Learning Task Score | To examine short-term and long-term effects of treatment on cognition and real-life outcomes. The participant will undergo neuropsychological testing at baseline, post-training (4 weeks), as well as 3-months post-training. Scores on the scale range from 0 to 16 on the California Verbal Learning Task. Higher the values are better their memory. | Baseline to 4 weeks and 3 months post-training |
| Measure | Description | Time Frame |
|---|---|---|
| Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation | Non-invasive estimation of rCBF by perfusion maps using pseudo-continuous arterial spin labeling (pCASL) MRI. rCBF is quantified as mL/min/100g tissue. | Two longitudinal measurements at baseline and 1-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra Chapman, PhD | The University of Texas at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTD Center for BrainHealth | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26022770 | Background | Hsu WY, Ku Y, Zanto TP, Gazzaley A. Effects of noninvasive brain stimulation on cognitive function in healthy aging and Alzheimer's disease: a systematic review and meta-analysis. Neurobiol Aging. 2015 Aug;36(8):2348-59. doi: 10.1016/j.neurobiolaging.2015.04.016. Epub 2015 May 1. |
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331 participants were screened for eligibility criteria, of which 52 participants were eligible for the study. Of the 52, a total of 30 participants dropped out due to time constraints, inability to complete the scans and/or after recommendation by the neurologist who questioned if they truly met eligibility criteria.
22 participants consented for the study of which 15 were included in the final analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | tDCS+Training | This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session. |
| FG001 | Sham tDCS+Training | This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks. Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Individuals in this study had memory complaints as supported by objective cognitive testing but were functionally independent. A neurologist confirmed the diagnosis of mild cognitive impairment based on objective cognitive testing.
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS+Training | This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement. |
| 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 From Baseline in California Verbal Learning Task Score | To examine short-term and long-term effects of treatment on cognition and real-life outcomes. The participant will undergo neuropsychological testing at baseline, post-training (4 weeks), as well as 3-months post-training. Scores on the scale range from 0 to 16 on the California Verbal Learning Task. Higher the values are better their memory. | 22 participants consented to the study of which 15 participants were in the final analysis | Posted | Mean | Standard Deviation | score on a scale | Baseline to 4 weeks and 3 months post-training |
|
Baseline to 4 months
Two participants had adverse events in the study: 1 participant had a minor burn from the tDCS and a 2nd participant became dizzy and vomited at the scanner.
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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 | tDCS+Training | This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks tDCS: Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Baseline at 1pm on June 26th 2017 for 15 minutes | Gastrointestinal disorders | Non-systematic Assessment | The participant experienced dizziness in the 7T scanner, which persisted past the initial few minutes of the scan. |
Participant enrollment was limited due to constraints on time and funding sources.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Namrata Das | Center for BrainHealth, The university of Texas at Dallas | 9728833266 | Namrata.Das@utdallas.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 | Jul 10, 2017 | May 7, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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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|
| Sham tDCS | Device | For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group. |
|
| BG001 | Sham tDCS+Training | This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks. Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Overall, the number of participants completed the cognitive training and tDCS stimulation protocol is 32 of which only 22 participant data were useable. The reason for attrition is due to either noncompliance of training or unable to use the MRI data due to movement. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Sham tDCS+Training | This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks. Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group. |
|
|
| Secondary | Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation | Non-invasive estimation of rCBF by perfusion maps using pseudo-continuous arterial spin labeling (pCASL) MRI. rCBF is quantified as mL/min/100g tissue. | Participants between ages 50-80 years had a diagnosis of mild cognitive impairment (MCI)based on Petersen's or Alzheimer's Disease Neuroimaging Initiative (ADNI) criteria from the Dallas-Fort worth community. | Posted | Mean | 95% Confidence Interval | ml/min/100g tissue scaled by whole brain | Two longitudinal measurements at baseline and 1-month |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Sham tDCS+Training | This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks. Sham tDCS: For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group. | 0 | 7 | 0 | 7 | 0 | 7 |
|
| Baseline on February 26th 2017 for 1week on March 2nd 2017 | Injury, poisoning and procedural complications | Non-systematic Assessment | One subject observed a burn on the right deltoid the site of tDCS stimulation electrode. The scar subsided in 1 week |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |