Skip to main content
OpenTrials
Completed

NCT Number: NCT05077826

Enhancing Memory in Mild Cognitive Impairment and Early Stage Alzheimer's Disease

The investigators have developed a low-risk transcranial Electrical Stimulation (tES) treatment that has improved learning and performance in young adults up to nearly 4 times when compared with a sham control. This randomized pilot trial will determine if this same tES protocol improves memory in older adults (50-90 years old) who are healthy, and separately in older adults with mild cognitive impairment (MCI) or early stage Alzheimer's disease (AD). TES will be applied to the right temple and left arm for up to 40 minutes. MRI images, along with other measures, may be obtained before and after tES. If effective, this intervention may help to improve the quality of life for AD patients and their families.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mind Research Network

Albuquerque, New Mexico, 87106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for healthy participants:

  • 50-90 years of age, as verified via photo identification with date of birth.
  • Should be right-handed and learned English by seven years old.
  • Generally healthy

Inclusion criteria

for participants with MCI or AD:

  • 50-90 years of age, as verified via photo identification with date of birth.
  • Should be right-handed and learned English by seven years old.
  • Is legally able to sign the consent form on their own behalf, or has a legally authorized representative that is able to sign.
  • Has a caregiver that can assist with taking health history.

Exclusion criteria

Exclusion criteria

for healthy participants:

  • Significant history of psychiatric disorders or current psychosis including self-report or Geriatric Depression Scale short form score-GDS >5 if uncertain.
  • Current excessive drug, alcohol or nicotine use defined by participant self-report.
  • History of epilepsy, migraines, severe stroke, or traumatic brain injury.
  • Taking medications with significant psychotropic effects.
  • Severe sensory impairment.
  • Severe chronic illness where participation in the study could put participants at an unusual level of risk. Chronic conditions will be evaluated on a case by case basis as they arise.
  • Severe subjective cognitive concerns.
  • Requires a helper animal.
  • Has sufficient prior experience with neurostimulation that might unblind or alter the results.
  • Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation or be an MRI contraindication, or has any other MRI contraindication.
  • Has sensitivity to components of tES electrodes being used (typically nickel or latex).
  • Feels ill or have any potential COVID-19 symptoms, such as fever or chills, cough, difficulty breathing, overly tired, unusual aches or pains including headache or sore throat, recent or unusual (for them) loss of taste or smell, congestion or runny nose, nausea or diarrhea.

Exclusion criteria

for participants with MCI or AD:

  • Significant history of psychiatric disorders or current psychosis not related to a neurodegenerative condition.
  • Current excessive drug, alcohol or nicotine use.
  • Significant history of epilepsy, stroke, or traumatic brain injury.
  • Taking medications with significant psychotropic effects, not related to neurodegenerative condition
  • Severe sensory impairment
  • Severe chronic illness where participation in the study could put participants at an unusual level of risk. Chronic conditions will be evaluated on a case by case basis as they arise.
  • Requires a helper animal.
  • Has sufficient prior experience with neurostimulation that might unblind or alter the results.
  • Has metal or electronic implants that may be sensitive to stimulation or could interfere with stimulation.
  • Has sensitivity to components of tES electrodes being used (typically nickel or latex).
  • Feels ill or have any potential COVID-19 symptoms, such as fever or chills, cough, difficulty breathing, overly tired, unusual aches or pains including headache or sore throat, unusual loss of taste or smell, or unusual (for them) congestion or runny nose, nausea or diarrhea.

Treatment and study plan

North Coast Medical Activadose II

Device

tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.

Primary outcomes

  1. Learning Task Performance

    Time frame: Within one hour after treatment

    Performance accuracy on a complex visual learning and categorization task after full-current tES in comparison to partial-current tES.

Sponsors and collaborators

Lead sponsor

The Mind Research Network

Other

Registry information

Official study title

Modern Energetic Methods of Response Improvement (MEMORI)

Acronym: MEMORI

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2021
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.