FatiguePhase 1NCT02840214
Impact of Transcranial Direct Current Stimulation on Fatigability and Fatigue Induced by a Selective Attention Task
A Phase 1 study testing transcranial direct current stimulation in people with Fatigue, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- right-handed
- normal or corrected-normal vision,
Who cannot join
- pregnant women,
- history of medical conditions associated with fatigue, including, but not limited to:
- Parkinson's disease,
- Alzheimer's disease,
- diabetes mellitus,
- hypothyroidism,
Show all 10Show fewer
- chronic fatigue syndrome,
- anemia,
- infectious mononucleosis,
- irritable bowel syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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.
Read the 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
- Being tested
- transcranial direct current stimulation, sham tDCS
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called tDCS
Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.
sham tDCSDevice
Also called Placebo
Soterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 3 hours of a single fatigability task (one time visit study)
Secondary outcomes (1)
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.
Measured: Baseline then every 30 minutes for 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Primary completionJun 2017 (estimated)
Why it stopped: Study was never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benzi Kluger, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840214
- Sponsor's protocol ID
- 15-1035
- Status last verified
- Jun 2017
- First submitted
- 27 Jun 2016
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Deidentified data may be released to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcranial Direct Current Stimulation on Fatigability and Fatigue Induced by a Selective Attention Task
- ClinicalTrials.gov ID
- NCT02840214
- Acronym / sponsor ID
- 15-1035
- Conditions
- Fatigue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Primary completion
- Jun 2017 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS rescue group | Active comparator | Device: transcranial direct current stimulationSubjects 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. |
| Sham Treatment Group | Placebo comparator | Device: sham tDCSSubjects assigned to this arm will initially receive current of the same intensity for a period of 30 seconds and then gradually turned off. |
| tDCS prevent group | Active comparator | Device: transcranial direct current stimulationSubjects 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- right-handed
- normal or corrected-normal vision,
Key exclusion criteria (10 listed)
- pregnant women,
- history of medical conditions associated with fatigue, including, but not limited to:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationAlso: tDCSSoterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA. | Device | tDCS prevent group, tDCS rescue group |
| sham tDCSAlso: PlaceboSoterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current | Device | Sham Treatment Group |
Primary outcome
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.
1 secondary outcome
Change in perceived fatigue
Time frame: Baseline then every 30 minutes for 3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: Yes. Deidentified data may be released to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benzi Kluger, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transcranial direct current stimulation in people with Fatigue, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performance fatigability (time frame: over 3 hours of a single fatigability task (one time visit study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.