An interventional study of Transcranial alternating current stimulation in Mild Cognitive Impairment, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Treatment
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 14 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will receive gamma stimulation
Device: Transcranial alternating current stimulation
Transcranial alternating current stimulation (tACS) will be applied at 40 Hz (gamma band) during eight sessions over the course of a month.
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.
Time frame: 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Drop out rate will be assessed as the number of participants who withdraw or are withdrawn from the study.
Time frame: post-tACS, up to 1 month
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.
Time frame: pre-tACS (baseline) and post-tACS (1 month)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: pre-tACS (baseline), post-tACS (after one month of treatment)
| Milestone | Gamma Stimulation Group |
|---|---|
| Started | 14 |
| Completed | 13 |
| Not completed | 1 |
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.
| units on a scale | Gamma Stimulation Group |
|---|---|
| Side Effects | 0.53 ± 0.65 |
Drop out rate will be assessed as the number of participants who withdraw or are withdrawn from the study.
| Participants | Gamma Stimulation Group |
|---|---|
| Drop Out | 1 |
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.
| unitless ratio | Gamma Stimulation Group |
|---|---|
| Beta Amyloid Load Change | 0.0008 ± 0.006 |
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.
| words correct | Gamma Stimulation Group |
|---|---|
| Memory: Recall Change | 1.5 ± 2.1 |
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.
| percent correct | Gamma Stimulation Group |
|---|---|
| Memory: Paired Associates Change | 11.5 ± 21.0 |
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.
| number of items named | Gamma Stimulation Group |
|---|---|
| Memory: Fluency Change | 1.5 ± 2.6 |
Plasma tau levels was assessed pre and post intervention. Change was calculated as post minus pre. Greater decrease is better.
| pg/mL | Gamma Stimulation Group |
|---|---|
| Change in Tau | 0.27 ± 0.72 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gamma Stimulation Group | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Gamma Stimulation Group |
|---|---|
| Mean | 74 ± 5 |
| Sex: Female, Male(Participants) | Gamma Stimulation Group |
|---|---|
| Female | 6 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | Gamma Stimulation Group |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Gamma Stimulation Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Gamma Stimulation Group |
|---|---|
| United States | 13 |
| Beta Amyloid(unitless ratio) | Gamma Stimulation Group |
|---|---|
| Mean | 0.06 ± 0.02 |
| Tau(pg/mL) | Gamma Stimulation Group |
|---|---|
| Mean | 3.38 ± 0.97 |
| Memory: Recall(number of items correctly remembered) | Gamma Stimulation Group |
|---|---|
| Mean | 6.54 ± 4.29 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco