N/A N=42 Randomized Double-blind Treatment

Patient Centered-Rehabilitation ver111090.1

Cognitive Change

Bottom Line

View on ClinicalTrials.gov: NCT03034954 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Object Location Touchscreen Task (Version C) Free Recall Total Error — 121.498; 99.77 centimeters — p=.300

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active HD-tDCS (Device); Sham HD-tDCS (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Object Location Touchscreen Task (Version C) Free Recall Total Error	121.498; 99.77	.300
PRIMARY Object Location Touchscreen Task (Version C) Free Recall Average Error	8.099; 6.652	—
PRIMARY Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond	3419.878; 3029.648	.044 sig
PRIMARY Object Location Touchscreen Task (Version C) Cued Recall Total Error	66.806; 43.775	—
PRIMARY Object Location Touchscreen Task (Version C) Cued Recall Average Error	4.453; 2.919	—
PRIMARY Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond	3991.659; 2666.858	.15
PRIMARY Object Location Touchscreen Task (Version C) Recognition Total Correct	12.79; 13.45	—
PRIMARY Object Location Touchscreen Task (Version C) Recognition Average Time to Respond	2804.459; 1903.39	.3
PRIMARY Performance (d') on a Simple Attention (0-back) Test	4.26; 4.25	—
PRIMARY Performance (d') on a Working Memory (2-back) Test	3.05; 2.94	—
PRIMARY Performance (d') on a Working Memory (Semantic 2-back) Test	1.518; 1.69	—
PRIMARY Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')	-1.130; -1.31	—
PRIMARY Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')	-2.69; -2.56	.450
SECONDARY Blinding in Total Sample	9; 6; 9; 8; 1; 7	.078
SECONDARY Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session	19; 18; 0; 3; 0; 0	.233
SECONDARY Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session	19; 21; 0; 0; 0; 0	—
SECONDARY Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session	16; 20; 1; 0; 1; 1	.600
SECONDARY Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session	6; 7; 12; 11; 1; 2	.999
SECONDARY Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session	16; 14; 3; 7; 0; 0	.281
SECONDARY Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session	9; 7; 10; 8; 0; 5	.082
SECONDARY Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session	19; 19; 0; 2; 0; 0	.490
SECONDARY Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session	19; 18; 0; 2; 0; 1	.488
SECONDARY Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session	17; 21; 2; 0; 0; 0	.219
SECONDARY Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session	19; 21; 0; 0; 0; 0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03034954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.