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

• ClinicalTrials.gov Identifier: NCT02840214
• Recruitment Status: Withdrawn
• First Posted: July 21, 2016
• Last Update Posted: July 2, 2017
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Tracking Information

• First Submitted Date: June 27, 2016
• First Posted Date: July 21, 2016
• Last Update Posted Date: July 2, 2017
• Study Start Date: Not Provided
• Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Transcranial Direct Current Stimulation on Fatigability and Fatigue Induced by a Selective Attention Task
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Fatigue

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: June 28, 2017): 0
• Original Estimated Enrollment (submitted: July 18, 2016): 45
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

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,
  • anemia,
  • infectious mononucleosis,
  • irritable bowel syndrome

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02840214
• Other Study ID Numbers: 15-1035
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: University of Colorado, Denver
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Colorado, Denver
• Verification Date: June 2017