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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG062395 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The overall goal of this project is to improve cognitive control abilities in adults with mild cognitive impairment (MCI) through a form of non-invasive brain stimulation, transcranial alternating current stimulation (tACS).
30 older adults aged 60-80 years with md-aMCI were randomized to 8 sessions of transcranial alternating current stimulation (tACS) with simultaneous cognitive control training (CCT). The intervention took place within the participant's home without direct researcher assistance. Half of the participants received prefrontal theta tACS during CCT and the other half received control tACS. Outcomes were assessed pre and post intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theta Stimulation Group | Experimental | This group will receive 6 Hz (theta) stimulation |
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| Delta Stimulation Group | Active Comparator | This group will receive 1 Hz (delta) stimulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial alternating current stimulation | Device | Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4 |
| Measure | Description | Time Frame |
|---|---|---|
| Divided Attention Performance | Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better. | Post-tACS (1-day follow-up), approximately 1 week after baseline |
| Divided Attention Performance | Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better. | Post-tACS (1-month follow-up), approximately 1 month after baseline |
| Sustained Attention Performance | Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better. | Post-tACS (1-day follow-up), approximately 1 week after baseline |
| Sustained Attention Performance | Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better. | Post-tACS (1-month follow-up), approximately 1 month after baseline |
| Working Memory Performance | Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares. | Post-tACS (1-day follow-up), approximately 1 week after baseline |
| Working Memory Performance | Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares |
| Measure | Description | Time Frame |
|---|---|---|
| Instrumental Activities of Daily Living (IADL) | Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4). | Post-tACS (1-day follow-up), approximately 1 week after baseline |
| Instrumental Activities of Daily Living (IADL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore Zanto, Ph.D. | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States |
The dataset includes self-reported information, behavioral and electrophysiological data. The final dataset will be stripped of identifiers prior to release for sharing, thereby anonymizing the data. We will make the anonymized data available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to attempt to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. This will be in accordance with human subject regulations.
The data will be available after the results have been determined and the study researchers are unblinded. The data will be available indefinitely upon request.
Contact PI.
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| ID | Title | Description |
|---|---|---|
| FG000 | Theta Stimulation Group | This group will receive 6 Hz (theta) stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4 |
| FG001 | Delta Stimulation Group | This group will receive 1 Hz (delta) stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Theta Stimulation Group | This group will receive 6 Hz (theta) stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4 |
| BG001 | Delta Stimulation Group |
| 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 | Divided Attention Performance | Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | difficulty level acheived | Post-tACS (1-day follow-up), approximately 1 week after baseline |
|
1 year
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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 | Theta Stimulation Group | This group received 6 Hz (theta) stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore Zanto | University of California San Francisco | 415-502-7322 | theodore.zanto@ucsf.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 | Nov 2, 2021 | Apr 19, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2021 | Dec 27, 2022 | ICF_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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| Post-tACS (1-month follow-up), approximately 1 month after baseline |
Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4). |
| Post-tACS (1-month follow-up), approximately 1 month after baseline |
This group will receive 1 Hz (delta) stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Divided Attention | Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. | Difficulty level is a continuous unitless quantity that relates to the difficulty of the task. Higher is better. | Mean | Standard Deviation | difficulty level achieved |
|
| Sustained Attention | Sustained attention was assessed via response times during the continuous performance task. | Response times to visual targets. Lower is better. | Mean | Standard Deviation | milliseconds |
|
| Working Memory | Working memory was assessed as the average maximum number correct from the ACE-X span tasks. | Number of items remembered. Higher is better. | Mean | Standard Deviation | number correct |
|
| Instrumental Activities of Daily Living | Higher is better (max = 4) | Mean | Standard Deviation | score on a scale |
|
This group received 1 Hz (delta) stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4 |
|
|
| Primary | Divided Attention Performance | Divided attention was assessed as the difficulty level achieved during perceptual discrimination performance while participants were engaged in the Akili AKL-T01 task. Higher is better. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | difficulty level acheived | Post-tACS (1-month follow-up), approximately 1 month after baseline |
|
|
|
| Primary | Sustained Attention Performance | Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | milliseconds | Post-tACS (1-day follow-up), approximately 1 week after baseline |
|
|
|
| Primary | Sustained Attention Performance | Sustained attention was assessed via response times to visual targets during the continuous performance task. Lower is better. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | milliseconds | Post-tACS (1-month follow-up), approximately 1 month after baseline |
|
|
|
| Primary | Working Memory Performance | Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | number correct | Post-tACS (1-day follow-up), approximately 1 week after baseline |
|
|
|
| Primary | Working Memory Performance | Working memory was assessed as the average maximum number correct from the ACE-X span tasks - memory for order of illuminated squares | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | number correct | Post-tACS (1-month follow-up), approximately 1 month after baseline |
|
|
|
| Secondary | Instrumental Activities of Daily Living (IADL) | Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4). | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Post-tACS (1-day follow-up), approximately 1 week after baseline |
|
|
|
| Secondary | Instrumental Activities of Daily Living (IADL) | Scores on the IADL will be assessed pre and post intervention. Higher scores are better (minimum = 0, maximum = 4). | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | score on a scale | Post-tACS (1-month follow-up), approximately 1 month after baseline |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Delta Stimulation Group | This group received 1 Hz (delta) stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied across the prefrontal cortex near electrodes coordinates AF3/AF4 | 0 | 15 | 0 | 15 | 0 | 15 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |