Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory
2 other identifiers
interventional
14
1 country
1
Brief Summary
This project assessed the feasibility of transcranial alternating current stimulation in the gamma band to lower beta-amyloid load and improve memory performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2020
CompletedFirst Posted
Study publicly available on registry
November 30, 2020
CompletedStudy Start
First participant enrolled
January 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedResults Posted
Study results publicly available
July 27, 2023
CompletedJuly 27, 2023
July 1, 2023
12 months
November 10, 2020
December 28, 2022
July 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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Drop out rate will be assessed as the number of participants who withdraw or are withdrawn from the study.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
Secondary Outcomes (5)
Beta Amyloid Load Change
pre-tACS (baseline) and post-tACS (1 month)
Memory: Recall Change
pre-tACS (baseline), post-tACS (after one month of treatment)
Memory: Paired Associates Change
pre-tACS (baseline), post-tACS (after one month of treatment)
Memory: Fluency Change
pre-tACS (baseline), post-tACS (after one month of treatment)
Change in Tau
pre-tACS (baseline), post-tACS (after one month of treatment)
Study Arms (1)
Gamma Stimulation Group
EXPERIMENTALThis group will receive gamma stimulation
Interventions
Transcranial alternating current stimulation (tACS) will be applied at 40 Hz (gamma band) during eight sessions over the course of a month.
Eligibility Criteria
You may qualify if:
- English speaking
- Grade 12 or more education
- Normal or corrected to normal vision and hearing
- Ability to complete cognitive tasks
- Ability to cooperate and comply with all study procedures
- Ability to tolerate tACS
- Self-reported memory complaint
- Diagnosed with mild cognitive impairment
- Amyloid positive
You may not qualify if:
- Neurological or psychiatric disorders other than mild cognitive impairment
- Receiving investigational medications or have participated in a trial with investigational medications within last 30 days
- Family history of epilepsy
- Implanted electronic devices (e.g., pacemaker)
- Prior head trauma
- Pregnant
- IQ \< 80
- Taking cholinesterase inhibitory, memantine, or psychotropic medication
- Taking anti-depressants or anti-anxiety medication
- Color blind
- Substance abuse
- Glaucoma
- Macular degeneration
- Amblyopia (lazy eye)
- Strabismus (crossed eyes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94158, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Theodore Zanto
- Organization
- University of California San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Theodore Zanto, Ph.D.
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2020
First Posted
November 30, 2020
Study Start
January 18, 2021
Primary Completion
December 31, 2021
Study Completion
May 31, 2022
Last Updated
July 27, 2023
Results First Posted
July 27, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 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.
- Access Criteria
- Contact PI.
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.