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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04646499
• Other study ID #: 131887a
• Secondary ID: R21AG060335
• Status: Completed
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project assessed the feasibility of transcranial alternating current stimulation in the gamma band to lower beta-amyloid load and improve memory performance.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Average of all post-tACS sessions, up to 1 month
Primary	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	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)
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.	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.	pre-tACS (baseline), post-tACS (after one month of treatment)
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.	pre-tACS (baseline), post-tACS (after one month of treatment)
Secondary	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)