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Withdrawn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
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Condition or disease | Intervention/treatment | Phase |
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Fatigue | Device: transcranial direct current stimulation Device: sham tDCS | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Estimated Primary Completion Date : | June 2017 |
Arm | Intervention/treatment |
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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.
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Device: transcranial direct current stimulation
Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.
Other Name: 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.
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Device: sham tDCS
Soterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current
Other Name: 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.
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Device: transcranial direct current stimulation
Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.
Other Name: tDCS |
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- right-handed
- normal or corrected-normal vision,
Exclusion Criteria:
- pregnant women,
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840214
United States, Colorado | |
University of Colorado Denver | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Benzi Kluger, MD | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02840214 |
Other Study ID Numbers: |
15-1035 |
First Posted: | July 21, 2016 Key Record Dates |
Last Update Posted: | July 2, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Deidentified data may be released to other researchers upon request. |
Fatigue |