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

NCT02840214 | Withdrawn Phase 1

• 1 other identifier: 15-1035
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in perceived fatigue

  Baseline then every 30 minutes for 3 hours

Study Arms (3)

tDCS rescue group

ACTIVE COMPARATOR

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.

Device: transcranial direct current stimulation

Sham Treatment Group

PLACEBO COMPARATOR

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

Device: sham tDCS

tDCS prevent group

ACTIVE COMPARATOR

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.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

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

Also known as: tDCS

tDCS prevent group; tDCS rescue group

sham tDCS DEVICE

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

Also known as: Placebo

Sham Treatment Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• right-handed
• normal or corrected-normal vision,

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Fatigue

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Benzi Kluger, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 21, 2016
• Primary Completion: June 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)