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

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ClinicalTrials.gov Identifier: NCT04646499
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : September 30, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This project will assess the feasibility of transcranial alternating current stimulation in the gamma band to lower beta-amyloid load and improve memory performance.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: Transcranial alternating current stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Gamma Transcranial Alternating Current Stimulation to Reduce Beta-amyloid Load and Improve Memory
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis Memory

Arm Intervention/treatment
Experimental: Gamma Stimulation Group
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.




Primary Outcome Measures :
  1. Side effects [ Time Frame: post-tACS (after one day of treatment) ]
    12 side effects will be 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, phosphenes, back pain, dizziness.

  2. Drop out [ Time Frame: post-tACS (after one month of treatment) ]
    Drop out rate will be assessed as the number of participants who withdraw or are withdrawn from the study.


Secondary Outcome Measures :
  1. Beta amyloid load [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in plasma beta amyloid load will be assessed pre and post intervention.

  2. Memory: Recall [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in episodic memory will be assessed pre and post intervention as accuracy for word lists from the California Verbal Learning Test.

  3. Memory: Paired Associates [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in episodic memory will be assessed pre and post intervention from memory accuracy for a paired associates task.

  4. Memory: Fluency [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in episodic memory will be assessed pre and post intervention from performance on the FAS task.

  5. Change in tau [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in plasma tau levels will be assessed pre and post intervention.


Other Outcome Measures:
  1. Resting state functional connectivity (RSFC) [ Time Frame: pre-tACS ]
    RSFC will be assessed as a predictor of tACS effects. Modularity will be calculated and used in a regression model.

  2. Change in Resting state functional connectivity (RSFC) [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in RSFC will be assessed pre and post intervention.

  3. Magnetic resonance spectroscopy (MRS) [ Time Frame: pre-tACS ]
    MRS will be assessed as a predictor of tACS effects. The ratio of excitatory (GLX+) to inhibitory (GABA) neurotransmitters will be used in a regression model.

  4. Change in Magnetic resonance spectroscopy (MRS) [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in MRS will be assessed pre and post intervention.

  5. Modeled electric field (EF) [ Time Frame: pre-tACS ]
    EF will be assessed as a predictor of tACS effects. EF magnitude will be calculated from T1 and T2 images, and used in a regression model.

  6. Instrumental activities of daily living (IADL) [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in IADL will be assessed pre and post intervention.

  7. Neurofilament Light [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in blood neurofilament light levels will be assessed pre and post intervention.

  8. Neurogranin [ Time Frame: pre-tACS (baseline), post-tACS (after one month of treatment) ]
    Change in blood neurogranin levels will be assessed pre and post intervention.



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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646499


Contacts
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Contact: Theodore Zanto, Ph.D. 415-364-8209 theodore.zanto@ucsf.edu
Contact: Avery Ostrand, B.S. 415-364-8209 avery.ostrand@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Avery Ostrand, B.S.    415-364-8209    avery.ostrand@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Theodore Zanto, Ph.D. University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04646499    
Other Study ID Numbers: 131887a
R21AG060335 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized IPD will be shared in accordance with NIH guidelines and IRB approval.

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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
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders