Patient Centered-Rehabilitation ver111090.1

NCT03034954 | Completed Results

• 1 other identifier: HUM00111090.1 PCN
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Change

Outcome Measures

Primary Outcomes (13)

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

  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.

  15 minutes after encoding

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

  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.

  15 minutes after encoding

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

  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.

  15 minutes after encoding

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

  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.

  15 minutes after encoding

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

  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.

  15 minutes after encoding

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

  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.

  15 minutes after encoding

• Object Location Touchscreen Task (Version C) Recognition Total Correct

  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.

  15 minutes after encoding

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

  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.

  15 minutes after encoding

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

  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.

  30 minutes post-stimulation

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

  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.

  30 minutes post-stimulation

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

  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.

  30 minutes post-stimulation

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

  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.

  30 minutes post-stimulation

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

  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.

  30 minutes post-stimulation

Secondary Outcomes (11)

• Blinding in Total Sample

  ~1 minute post stimulation

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

  ~1 minute post stimulation

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

  ~1 minute post stimulation

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

  ~1 minute post stimulation

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

  ~1 minute post stimulation

Study Arms (2)

Active HD-tDCS

ACTIVE COMPARATOR

Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session.

Device: Active HD-tDCS

Sham HD-tDCS

SHAM COMPARATOR

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Device: Sham HD-tDCS

Interventions

Active HD-tDCS DEVICE

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

Also known as: HD-tDCS

Active HD-tDCS

Sham HD-tDCS DEVICE

Participants will receive sham HD-tDCS

Sham HD-tDCS

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan - Department of Psychiatry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.

  PMID: 21320389 BACKGROUND

Results Point of Contact

• Title: Dr. Annalise Rahman-Filipiak
• Organization: University of Michigan

rahmanam@med.umich.edu

734-763-9259

Study Officials

• Benjamin M Hampstead, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: January 27, 2017
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 16, 2018
• Results First Posted: August 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)