N/A
N=10
4 mA tDCS, Estrogen, and Leg Muscle Fatigability
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04471805 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Fatigue Index From the Isokinetic Fatigue Test — 61.7; 46.7; 57.28; 55.90 Percent decline — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sham transcranial direct current stimulation 4 mA (Device); Transcranial direct current stimulation 4 mA (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Iowa
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue Index From the Isokinetic Fatigue Test |
61.7; 46.7; 57.28; 55.90 | <0.05 sig |
| PRIMARY Muscle Activity During the Strength and Fatigue Tests |
95.15; 91.83; 77.53; 82.35 | <0.05 sig |
| SECONDARY Estrogen Level |
157.7; 31.9; 137.2; 42.9 | — |
Summary
The majority of transcranial direct current stimulation (tDCS) studies have failed to consider sex as a modulating factor. This neglect may partly account for the high inter-subject variability bemoaned by many tDCS investigators (e.g., approximately 50% of participants do not respond to tDCS) and has certainly delayed progress in the field. Therefore, research into how sex influences stimulation-related outcomes is vital to fully understand the underlying mechanisms of tDCS, which has shown great inconsistency.
Because of the menstrual cycle, the hormonal levels of women fluctuate considerably more than in men. Importantly, these hormonal variations might impact the efficacy of neuromodulatory tools, like tDCS. It is suggested that estrogen, which is high in the second follicular phase, reinforces excitatory mechanisms in the motor cortex. However, because anodal tDCS enhances cortical excitation there is also a possibility of excessive excitability. For instance, anodal tDCS may lead to overexcitation and non-optimal performance when it is applied in the second follicular phase of the menstrual cycle. Currently, there is a lack of knowledge on how the phases of the menstrual cycle affect tDCS performance outcomes in healthy young women because no studies have examined if and how the phases of the menstrual cycle alter tDCS efficacy.
This study is critical for determining the optimal time to administer anodal tDCS, and the ideal intensity for that administration, to achieve the most beneficial results. Furthermore, this investigation will emphasize the need for future tDCS studies to test women during the same menstrual cycle phase.
Eligibility Criteria
Inclusion Criteria
- Has a regular menstrual cycle
- Young adult (18-35 years)
- Right-side dominant
- 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.
Exclusion Criteria
- Pregnant
- Known holes or fissures in the skull
- Metallic objects or implanted devices in the skull (e.g., metal plate)
- Women on hormonal contraceptives/supplements.
Data sourced from ClinicalTrials.gov (NCT04471805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.