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

Primary Purpose

Fatigue

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
sham tDCS
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

tDCS rescue group

Sham Treatment Group

tDCS prevent group

Arm Description

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.

Subjects assigned to this arm will initially receive current of the same intensity for a period of 30 seconds and then gradually turned off.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 27, 2016
Last Updated
June 28, 2017
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02840214
Brief Title
Impact of Transcranial Direct Current Stimulation on Fatigability and Fatigue Induced by a Selective Attention Task
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never initiated.
Study Start Date
undefined (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS rescue group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham Treatment Group
Arm Type
Placebo Comparator
Arm Description
Subjects assigned to this arm will initially receive current of the same intensity for a period of 30 seconds and then gradually turned off.
Arm Title
tDCS prevent group
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Other Intervention Name(s)
Placebo
Intervention Description
Soterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current
Primary Outcome Measure Information:
Title
Change in cognitive performance fatigability
Description
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.
Time Frame
over 3 hours of a single fatigability task (one time visit study)
Secondary Outcome Measure Information:
Title
Change in perceived fatigue
Description
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.
Time Frame
Baseline then every 30 minutes for 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benzi Kluger, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data may be released to other researchers upon request.

Learn more about this trial

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

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