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

Fatigue Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02840214
• Other study ID #: 15-1035
• Status: Withdrawn
• Phase: Phase 1
• First received: June 27, 2016
• Last updated: June 28, 2017

Study information

• Verified date: June 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue

Intervention

Device:
• transcranial direct current stimulation
Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.
• sham tDCS
Soterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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