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

NCT ID: NCT02840214

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL

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.

Conditions

Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.

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.

Group Type: PLACEBO_COMPARATOR

sham tDCS

Intervention Type: DEVICE

Soterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current

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.

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type: DEVICE

Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.

Interventions

transcranial direct current stimulation

Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.

Intervention Type: DEVICE

sham tDCS

Soterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current

Intervention Type: DEVICE

Other Intervention Names

tDCS; Placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benzi Kluger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

Other Identifiers

15-1035

Identifier Type: -

Identifier Source: org_study_id