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

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ClinicalTrials.gov Identifier: NCT02840214
Recruitment Status : Withdrawn (Study was never initiated.)
First Posted : July 21, 2016
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE June 27, 2016
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE Not Provided
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
Change in perceived fatigue [ Time Frame: Baseline then every 30 minutes for 3 hours ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Transcranial Direct Current Stimulation on Fatigability and Fatigue Induced by a Selective Attention Task
Official Title  ICMJE Not Provided
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Fatigue
Intervention  ICMJE
  • Device: transcranial direct current stimulation
    Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.
    Other Name: tDCS
  • Device: sham tDCS
    Soterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current
    Other Name: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Device: transcranial direct current stimulation
  • 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.
    Intervention: Device: sham tDCS
  • 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.
    Intervention: Device: transcranial direct current stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 28, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
45
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840214
Other Study ID Numbers  ICMJE 15-1035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified data may be released to other researchers upon request.
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benzi Kluger, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP