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Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial alternating current stimulation
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gamma Stimulation Group

Arm Description

This group will receive gamma stimulation

Outcomes

Primary Outcome Measures

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.
Drop Out
Drop out rate will be assessed as the number of participants who withdraw or are withdrawn from the study.

Secondary Outcome Measures

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.
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.
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.
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.
Change in Tau
Plasma tau levels was assessed pre and post intervention. Change was calculated as post minus pre. Greater decrease is better.

Full Information

First Posted
November 10, 2020
Last Updated
July 26, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04646499
Brief Title
Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory
Official Title
Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gamma Stimulation Group
Arm Type
Experimental
Arm Description
This group will receive gamma stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial alternating current stimulation
Intervention Description
Transcranial alternating current stimulation (tACS) will be applied at 40 Hz (gamma band) during eight sessions over the course of a month.
Primary Outcome Measure Information:
Title
Side Effects
Description
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
Title
Drop Out
Description
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
Secondary Outcome Measure Information:
Title
Beta Amyloid Load Change
Description
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)
Title
Memory: Recall Change
Description
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)
Title
Memory: Paired Associates Change
Description
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)
Title
Memory: Fluency Change
Description
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)
Title
Change in Tau
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Zanto, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
Contact PI.

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Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory

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