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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG060335 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This project assessed the feasibility of transcranial alternating current stimulation in the gamma band to lower beta-amyloid load and improve memory performance.
Thirteen individuals with aMCI received eight 60-minute sessions of 40-Hz (gamma) transcranial alternating current stimulation (tACS) in a single-arm design. Outcome measures were assessed pre- and post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamma Stimulation Group | Experimental | This group will receive gamma stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial alternating current stimulation | Device | Transcranial alternating current stimulation (tACS) will be applied at 40 Hz (gamma band) during eight sessions over the course of a month. |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects | Side effects were measured on a scale from 0 (not noticable) to 10 (not tolerable): headache, neck pain, scalp pain, tingling, itching, burning sensation, increased sleepiness, trouble concentrating, acute mood change, and phosphenes. Average rating across all measures reported as indicator of side effects. | Average of all post-tACS sessions, up to 1 month |
| Drop Out | Drop out rate will be assessed as the number of participants who withdraw or are withdrawn from the study. | post-tACS, up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Beta Amyloid Load Change | Change in plasma-based beta amyloid (AB) load was assessed as the AB42/40 ratio, calculated as post minus pre AB42/40 ratio. Greater increase is better. | pre-tACS (baseline) and post-tACS (1 month) |
| Memory: Recall Change |
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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 | Gamma Stimulation Group | This group received gamma stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied at 40 Hz (gamma band) during eight sessions over the course of a month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gamma Stimulation Group | This group received gamma stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied at 40 Hz (gamma band) during eight sessions over the course of a month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | One participant was enrolled, but dropped out prior to data collection. |
| 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 | Side Effects | Side effects were measured on a scale from 0 (not noticable) to 10 (not tolerable): headache, neck pain, scalp pain, tingling, itching, burning sensation, increased sleepiness, trouble concentrating, acute mood change, and phosphenes. Average rating across all measures reported as indicator of side effects. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Average of all post-tACS sessions, up to 1 month |
|
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 | Gamma Stimulation Group | This group received gamma stimulation Transcranial alternating current stimulation: Transcranial alternating current stimulation (tACS) was applied at 40 Hz (gamma band) during eight sessions over the course of a month. |
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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_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2021 | Apr 19, 2023 | 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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Episodic memory was assessed pre and post intervention as the number of words correct during the short delay free recall portion of the California Verbal Learning Test. Change was assessed as post minus pre. Greater increase is better.
| pre-tACS (baseline), post-tACS (after one month of treatment) |
| Memory: Paired Associates Change | Episodic memory was assessed pre and post intervention from memory accuracy for a paired associates task for visual objects. Change was assessed post minus pre. Greater increase is better. | pre-tACS (baseline), post-tACS (after one month of treatment) |
| Memory: Fluency Change | Episodic memory fluency was assessed pre and post intervention from performance on the FAS task. Unit of measurement is the number of words names starting with the letter f, a, or s. Change was calculated as post minus pre. Greater increase is better. | pre-tACS (baseline), post-tACS (after one month of treatment) |
| Change in Tau | Plasma tau levels was assessed pre and post intervention. Change was calculated as post minus pre. Greater decrease is better. | pre-tACS (baseline), post-tACS (after one month of treatment) |
Only data from participants who completed the full protocol were analyzed.
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | One participant was enrolled, but dropped out prior to data collection. | Only data from participants who completed the full protocol were analyzed. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | One participant was enrolled, but dropped out prior to data collection. | Count of Participants | Participants |
|
| Race (NIH/OMB) | One participant was enrolled, but dropped out prior to data collection. | Count of Participants | Participants |
|
| Region of Enrollment | One participant was enrolled, but dropped out prior to data collection. | Count of Participants | Participants |
|
| Beta Amyloid | Plasma-based beta amyloid 42/40 ratio. | One participant was enrolled, but dropped out prior to data collection. Only data from participants who completed the full protocol were analyzed. Higher values indicate worse outcomes. | Mean | Standard Deviation | unitless ratio |
|
| Tau | Plasma-based measure of pTau181 | One participant was enrolled, but dropped out prior to data collection. Only data from participants who completed the full protocol were analyzed. Higher values indicate worse outcomes. | Mean | Standard Deviation | pg/mL |
|
| Memory: Recall | Short Delay Free Recall portion of the California Verbal Learning Test | One participant was enrolled, but dropped out prior to data collection. Only data from participants who completed the full protocol were analyzed. | Mean | Standard Deviation | number of items correctly remembered |
|
| Memory: Paired Associates | One participant was enrolled, but dropped out prior to data collection. Only data from participants who completed the full protocol were analyzed. | Mean | Standard Deviation | percentage of items correctly remembered |
|
| Memory: Fluency | Memory fluency was assessed via the FAS test. | One participant was enrolled, but dropped out prior to data collection. Only data from participants who completed the full protocol were analyzed. Higher is better. Unit is number of items named that start with the letter f, a, or s. | Mean | Standard Deviation | number of items named |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Drop Out | Drop out rate will be assessed as the number of participants who withdraw or are withdrawn from the study. | Posted | Count of Participants | Participants | post-tACS, up to 1 month |
|
|
|
| Secondary | Beta Amyloid Load Change | Change in plasma-based beta amyloid (AB) load was assessed as the AB42/40 ratio, calculated as post minus pre AB42/40 ratio. Greater increase is better. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | unitless ratio | pre-tACS (baseline) and post-tACS (1 month) |
|
|
|
|
| Secondary | Memory: Recall Change | Episodic memory was assessed pre and post intervention as the number of words correct during the short delay free recall portion of the California Verbal Learning Test. Change was assessed as post minus pre. Greater increase is better. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | words correct | pre-tACS (baseline), post-tACS (after one month of treatment) |
|
|
|
|
| Secondary | Memory: Paired Associates Change | Episodic memory was assessed pre and post intervention from memory accuracy for a paired associates task for visual objects. Change was assessed post minus pre. Greater increase is better. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | percent correct | pre-tACS (baseline), post-tACS (after one month of treatment) |
|
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|
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| Secondary | Memory: Fluency Change | Episodic memory fluency was assessed pre and post intervention from performance on the FAS task. Unit of measurement is the number of words names starting with the letter f, a, or s. Change was calculated as post minus pre. Greater increase is better. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | number of items named | pre-tACS (baseline), post-tACS (after one month of treatment) |
|
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|
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| Secondary | Change in Tau | Plasma tau levels was assessed pre and post intervention. Change was calculated as post minus pre. Greater decrease is better. | Only data from participants who completed the full protocol were analyzed. | Posted | Mean | Standard Deviation | pg/mL | pre-tACS (baseline), post-tACS (after one month of treatment) |
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| 0 |
| 13 |
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| 13 |
| 0 |
| 13 |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |