HealthyNCT04321304
Impact of Transcranial Direct Current Stimulation Intensity on Leg Muscle Fatigability in Healthy Adults
A study testing Transcranial direct current stimulation at 2 mA and Transcranial direct current stimulation at 4 mA in people with Healthy, run by University of Iowa at 1 site in United States.
Trial summary
Transcranial direct current stimulation (tDCS) is a painless,non-invasive means of increasing brain excitability. It has been used for several years and in many populations to improve physical and psychological outcomes. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcranial direct current stimulation at 2 mA and Transcranial direct current stimulation at 4 mA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Sep 2019
- Phase
- Interventional
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adult (18-30 yrs)
- right-side dominant
- able to independently walk for 6 min
- at least 30 min of moderate-intensity, physical activity on at least 3 days of the week for at least the last 3 months
- without chronic neurological, psychiatric, or medical conditions
- not taking any psychoactive medications
Who cannot join
- pregnant
- known holes or fissures in the skull
- metallic objects or implanted devices in the skull (e.g., metal plate)
- current student of study personnel
- under the direct supervision of study personnel
Trial locations and contacts
1 site in 1 country.
About this study
Transcranial direct current stimulation (tDCS) is a painless,non-invasive means of increasing brain excitability. It has been used for several years and in many populations to improve physical and psychological outcomes. Although many tDCS devices are capable of a range of stimulation intensities (e.g., 0 mA - 5 mA), the intensities currently employed in most tDCS research are ≤ 2 mA, which are sufficient to elicit measurable improvements; but, these improvements might be expanded at higher intensities. In the beginning, when the safety of tDCS was still being established for human subjects, careful and moderate approaches to stimulation protocols were warranted. However, recent work using stimulation at higher intensities, i.e. up to 4 mA, has been performed in many populations and was found to have no additional negative side-effects. Now that the safety of tDCS at higher intensities is better established, work exploring the differences in performance between moderate (i.e. 2 mA) and higher (i.e. 4 mA) intensities is necessary to determine if increasing intensity increases the effectiveness of the desired outcome.
Prospective participants will include 40 healthy young adults (all right-side dominant) that will be recruited to complete four randomly ordered stimulation sessions (Baseline, 2 mA, 4 mA, and sham), separated by at least 5 days. Each session will involve one visit to the Integrative Neurophysiology Laboratory (INPL) and will last for approximately one hour. We expect data collection to last 6 months. The first session includes leg strength measurements and fatigue tasks of both legs, as well as a baseline 6 min walk test (6MWT) to determine fatigued walking characteristics. The following three sessions will include performing a random tDCS condition (2 mA, 4 mA, or sham) over the brain area that controls the participant's dominant leg for 15 minutes prior to and then throughout the duration of the fatigue task of the dominant leg (16-20 min total stimulation time). The fatigue task for the nondominant leg will be performed after a 10 minute energy recovery period. After the fatigue task has been completed for both legs, the participants will perform the 6MWT.
- Conditions
- Healthy
- Being tested
- Sham transcranial direct current stimulation, Transcranial direct current stimulation at 2 mA, Transcranial direct current stimulation at 4 mA
- Keywords
- Brain Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham transcranial direct current stimulationDevice
Also called tDCS
Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.
Transcranial direct current stimulation at 2 mADevice
Uses weak electrical current (2 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
Transcranial direct current stimulation at 4 mADevice
Uses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Participants will have the anode (active electrode) placed over the brain area the controls their dominant leg and the cathode (return electrode) above the ipsilateral eyebrow. Stimulation is turned on (2 mA) for the 30 seconds at the beginning and the end of the trial, but stays at 0 mA in the intervening time. Receives: Device: Sham transcranial direct current stimulation |
| 2 mA | Experimental | Participants will have the anode (active electrode) placed over the brain area the controls their dominant leg and the cathode (return electrode) above the ipsilateral eyebrow. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. Receives: Device: Transcranial direct current stimulation at 2 mA |
| 4 mA | Experimental | Participants will have the anode (active electrode) placed over the brain area the controls their dominant leg and the cathode (return electrode) above the ipsilateral eyebrow. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. Receives: Device: Transcranial direct current stimulation at 4 mA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked in the 6 Minute Walk Test
Walk back and forth between two markers spaced 30 meters apart for six minutes
Measured: Through study completion, up to 6 months
Fatigue index from the isokinetic fatigue test
Perform 40 consecutive flexion and extension repetitions of the knee on the dominant leg. After a 10 minute rest, do the same task on the the non-dominant leg.
Measured: Through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 May 2019
- Primary completion24 Jun 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig D. Workman, PhD, University of Iowa
- Investigators
- Craig D Workman, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321304
- Sponsor's protocol ID
- 201902799
- Status last verified
- Jul 2021
- First submitted
- 23 Mar 2020
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcranial Direct Current Stimulation Intensity on Leg Muscle Fatigability in Healthy Adults
- ClinicalTrials.gov ID
- NCT04321304
- Acronym / sponsor ID
- 201902799
- Conditions
- Healthy
- Keywords
- Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 25 Mar 2020 (actual)
- 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.
Transcranial direct current stimulation (tDCS) is a painless,non-invasive means of increasing brain excitability. It has been used for several years and in many populations to improve physical and psychological outcomes. Although many tDCS devices are capable of a range of stimulation intensities (e.g., 0 mA - 5 mA), the intensities currently employed in most tDCS research are ≤ 2 mA, which are sufficient to elicit measurable improvements; but, these improvements might be expanded at higher intensities. In the beginning, when the safety of tDCS was still being established for human subjects, careful and moderate approaches to stimulation protocols were warranted. However, recent work using stimulation at higher intensities, i.e. up to 4 mA, has been performed in many populations and was found to have no additional negative side-effects. Now that the safety of tDCS at higher intensities is better established, work exploring the differences in performance between moderate (i.e. 2 mA) and higher (i.e. 4 mA) intensities is necessary to determine if increasing intensity increases the effectiveness of the desired outcome.
Prospective participants will include 40 healthy young adults (all right-side dominant) that will be recruited to complete four randomly ordered stimulation sessions (Baseline, 2 mA, 4 mA, and sham), separated by at least 5 days. Each session will involve one visit to the Integrative Neurophysiology Laboratory (INPL) and will last for approximately one hour. We expect data collection to last 6 months. The first session includes leg strength measurements and fatigue tasks of both legs, as well as a baseline 6 min walk test (6MWT) to determine fatigued walking characteristics. The following three sessions will include performing a random tDCS condition (2 mA, 4 mA, or sham) over the brain area that controls the participant's dominant leg for 15 minutes prior to and then throughout the duration of the fatigue task of the dominant leg (16-20 min total stimulation time). The fatigue task for the nondominant leg will be performed after a 10 minute energy recovery period. After the fatigue task has been completed for both legs, the participants will perform the 6MWT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Sham transcranial direct current stimulationParticipants will have the anode (active electrode) placed over the brain area the controls their dominant leg and the cathode (return electrode) above the ipsilateral eyebrow. Stimulation is turned on (2 mA) for the 30 seconds at the beginning and the end of the trial, but stays at 0 mA in the intervening time. |
| 2 mA | Experimental | Device: Transcranial direct current stimulation at 2 mAParticipants will have the anode (active electrode) placed over the brain area the controls their dominant leg and the cathode (return electrode) above the ipsilateral eyebrow. Stimulation is ramped up to 2 mA over the first 30 seconds and stays at 2 mA for the remainder of the stimulation time. |
| 4 mA | Experimental | Device: Transcranial direct current stimulation at 4 mAParticipants will have the anode (active electrode) placed over the brain area the controls their dominant leg and the cathode (return electrode) above the ipsilateral eyebrow. Stimulation is ramped up to 4 mA over the first 30 seconds and stays at 4 mA for the remainder of the stimulation time. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Young adult (18-30 yrs)
- right-side dominant
- able to independently walk for 6 min
- at least 30 min of moderate-intensity, physical activity on at least 3 days of the week for at least the last 3 months
- without chronic neurological, psychiatric, or medical conditions
Key exclusion criteria (5 listed)
- pregnant
- known holes or fissures in the skull
- metallic objects or implanted devices in the skull (e.g., metal plate)
- current student of study personnel
- under the direct supervision of study personnel
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 |
|---|---|---|
| Sham transcranial direct current stimulationAlso: tDCSUses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias. | Device | Sham |
| Transcranial direct current stimulation at 2 mAUses weak electrical current (2 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes. | Device | 2 mA |
| Transcranial direct current stimulation at 4 mAUses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes. | Device | 4 mA |
Primary outcome
Distance walked in the 6 Minute Walk Test
Time frame: Through study completion, up to 6 months
Walk back and forth between two markers spaced 30 meters apart for six minutes
Fatigue index from the isokinetic fatigue test
Time frame: Through study completion, up to 6 months
Perform 40 consecutive flexion and extension repetitions of the knee on the dominant leg. After a 10 minute rest, do the same task on the the non-dominant leg.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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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.
Craig D Workman, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation at 2 mA and Transcranial direct current stimulation at 4 mA in people with Healthy, run by University of Iowa 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 8 Jul 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Distance walked in the 6 Minute Walk Test (time frame: Through study completion, up to 6 months). The study lists 2 primary outcomes in all. 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 8 Jul 2021.