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Clinical Trials/NCT02840214
NCT02840214
Withdrawn
Phase 1

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

University of Colorado, Denver1 site in 1 countryJuly 21, 2016
ConditionsFatigue

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Fatigue
Sponsor
University of Colorado, Denver
Locations
1
Primary Endpoint
Change in cognitive performance fatigability
Status
Withdrawn
Last Updated
8 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2016
End Date
June 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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,
  • infectious mononucleosis,
  • irritable bowel syndrome

Outcomes

Primary Outcomes

Change in cognitive performance fatigability

Time Frame: over 3 hours of a single fatigability task (one time visit study)

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.

Secondary Outcomes

  • Change in perceived fatigue(Baseline then every 30 minutes for 3 hours)

Study Sites (1)

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