Impact of Transcranial Direct Current Stimulation on Fatigability and Fatigue Induced by a Selective Attention Task

This research project is focusing on changes in mental fatigue due to transcranial direct current stimulation (tDCS) in healthy individuals. The study aim is to see if mental fatigue can be rescued by administering a safe dose of tDCS. tDCS has been shown to decrease fatigue in healthy individuals experiencing extended wakefulness, and the investigators aim to investigate if similar results can be found in a fatigue inducing task. This is a single-blind randomized control trial that will compare mental fatigue between tDCS treatment and sham treatment groups through both subjective and objective measures. Objective fatigue will be measured by reaction time with the Stroop test and subjective fatigue will be measured by the multidimensional fatigue inventory questionnaire.

Study Overview

• Status: Withdrawn
• Conditions: Fatigue
• Intervention / Treatment: Device: transcranial direct current stimulation; Device: sham tDCS

Detailed Description

Right handed healthy individuals aged 18-40 will be eligible to participate. Participants will be randomized in a 1:1:1 ratio to receive real or placebo 2mA tDCS delivered for 20 minutes while performing a 3 hour computerized cued Stroop task. Groups will receive real or sham stimulation during the first 20 minutes or 90-110 minutes into the task. Groups will be: 1) Sham (sham given at both time points); 2) Prevent (real will be given during first 20 minutes to try to prevent or delay fatigue and sham given at second time point); or 3) Rescue (sham will be given initially and real given at 90-110 minutes to see if performance can be rescued after fatigue has set in). The primary outcome measure will be the slope of change for intra-individual variability of response time for correct items and regression models will be used to determine whether real preventative or rescue tDCS alters the rate of performance change relative to sham stimulation. Accuracy and mean response time will also be examined as secondary outcomes.

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• right-handed
• normal or corrected-normal vision,

Exclusion Criteria:

• pregnant women,

• history of medical conditions associated with fatigue, including, but not limited to:

  • Parkinson's disease,
  • Alzheimer's disease,
  • diabetes mellitus,
  • hypothyroidism,
  • chronic fatigue syndrome,
  • anemia,
  • infectious mononucleosis,
  • irritable bowel syndrome

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: tDCS rescue group; Subjects assigned to this arm will receive transcranial direct current stimulation (tDCS) that delivers a constant, small current (2 milliAmp) across specific regions of the brain through electrodes placed on the scalp half-way through the 3-hour fatigue task.	Device: transcranial direct current stimulation; Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.; Other Names: tDCS
Placebo Comparator: Sham Treatment Group; Subjects assigned to this arm will initially receive current of the same intensity for a period of 30 seconds and then gradually turned off.	Device: sham tDCS; Soterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current; Other Names: Placebo
Active Comparator: tDCS prevent group; Subjects assigned to this arm will receive transcranial direct current stimulation (tDCS) that delivers a constant, small current (2 milliAmp) across specific regions of the brain through electrodes placed on the scalp at the beginning of the task.	Device: transcranial direct current stimulation; Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.; Other Names: tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive performance fatigability	This will be measured by change in intraindividual variability of reaction time from the Stroop Fatigue Paradigm which will be quantified as the rate of change in mean reaction time over 3 hours modeled using linear regression.	over 3 hours of a single fatigability task (one time visit study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived fatigue	This will be assessed by visual analogue scale of fatigue performed at baseline and every 30 minutes of the task and the slope of change in perceived fatigue modeled using linear regression.	Baseline then every 30 minutes for 3 hours

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Benzi Kluger, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: June 27, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 15-1035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data may be released to other researchers upon request.