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OpenTrials
Completed

NCT Number: NCT03034954

Patient Centered-Rehabilitation ver111090.1

As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects of TES on working memory, learning, and memory, will be evaluated in a group of healthy older adults.

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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan - Department of Psychiatry

Ann Arbor, Michigan, 48109, United States

About this study

The primary objective is to investigate the cognitive effects of high definition anodal tDCS (HD-tDCS; anode at center electrode) at 3 mA (for 20 minutes) on learning, memory, and working memory. Participants will be randomized to active or sham stimulation and will complete a series of cognitive tests both during and after stimulation.

Tolerability and blinding will also be evaluated using standard side effect questionnaires.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals with intact cognitive functioning.
  • Participants will be age 50 or older.

Exclusion criteria

  • Individuals with a documented history of cognitive impairment.
  • A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders)
  • Sensory or motor impairments that limit the ability to take part in the study
  • A significant history or current use of alcohol or drug abuse/dependence
  • Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)
  • Participants with an Mini Mental State Examination score <24 at screening.

Treatment and study plan

Active HD-tDCS

Device

Participants will receive active HD-tDCS at 3mA for 20 minutes

Other names: HD-tDCS

Sham HD-tDCS

Device

Participants will receive sham HD-tDCS

Primary outcomes

  1. Object Location Touchscreen Task (Version C) Free Recall Total Error

    Time frame: 15 minutes after encoding

    The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.

  2. Object Location Touchscreen Task (Version C) Free Recall Average Error

    Time frame: 15 minutes after encoding

    The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.

  3. Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond

    Time frame: 15 minutes after encoding

    The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.

  4. Object Location Touchscreen Task (Version C) Cued Recall Total Error

    Time frame: 15 minutes after encoding

    The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.

  5. Object Location Touchscreen Task (Version C) Cued Recall Average Error

    Time frame: 15 minutes after encoding

    The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.

  6. Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond

    Time frame: 15 minutes after encoding

    The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the "room" or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.

  7. Object Location Touchscreen Task (Version C) Recognition Total Correct

    Time frame: 15 minutes after encoding

    The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.

  8. Object Location Touchscreen Task (Version C) Recognition Average Time to Respond

    Time frame: 15 minutes after encoding

    The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.

  9. Performance (d') on a Simple Attention (0-back) Test

    Time frame: 30 minutes post-stimulation

    The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.

  10. Performance (d') on a Working Memory (2-back) Test

    Time frame: 30 minutes post-stimulation

    The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.

  11. Performance (d') on a Working Memory (Semantic 2-back) Test

    Time frame: 30 minutes post-stimulation

    The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.

  12. Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')

    Time frame: 30 minutes post-stimulation

    The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.

  13. Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')

    Time frame: 30 minutes post-stimulation

    The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.

Secondary outcomes

  1. Blinding in Total Sample

    Time frame: ~1 minute post stimulation

    Participants were asked to estimate which group they were in (i.e., active or sham).

  2. Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

  3. Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

  4. Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

  5. Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

  6. Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

  7. Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

  8. Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

  9. Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

  10. Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

  11. Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session

    Time frame: ~1 minute post stimulation

    The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of "None, Mild, Moderate, or Severe".

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Effects of 3mA HD-tDCS on Associative and Working Memory in Cognitively Intact Older Adults

Acronym: PCN1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 27, 2017
Registry last updated
Aug 16, 2018

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.

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