Clinical trial NCT04321304: Impact of Transcranial Direct Current Stimulation Intensity on Leg Muscle Fatigability in Healthy Adults
Official title: Impact of Transcranial Direct Current Stimulation Intensity on Leg Muscle Fatigability in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Brain Stimulation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Young adult (18-30 yrs)
2. right-side dominant
3. able to independently walk for 6 min
4. at least 30 min of moderate-intensity, physical activity on at least 3 days of the week for at least the last 3 months
5. without chronic neurological, psychiatric, or medical conditions
6. not taking any psychoactive medications

Exclusion Criteria:

1. pregnant
2. known holes or fissures in the skull
3. metallic objects or implanted devices in the skull (e.g., metal plate)
4. current student of study personnel
5. under the direct supervision of study personnel

Primary outcomes:
measure: Distance walked in the 6 Minute Walk Test
timeFrame: Through study completion, up to 6 months
measure: Fatigue index from the isokinetic fatigue test
timeFrame: Through study completion, up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Craig D Workman, PhD
role: PRINCIPAL_INVESTIGATOR
References: