Healthy Participants
Conditions
Brief summary
The study is a randomized clinical trial that is assessing the effects of sensory training on pain modulation, cognition, and physical endurance (time to fatigue) in healthy participants
Interventions
DEVICEActive eMNS
Each session will consist of right eMNS stimulation that will last 20-minutes. The frequency of stimulation will be random assigned using random frequency interval. The electrodes that will be used will be standard transcutaneous electrodes. The electrodes will be placed on the wrist.
DEVICESham eMNS
Each session of sham eMNS will be the same as active, except the device will be turned off. Similar parameters will be used (for 20 minutes and same electrode placement), except no stimulation will be delivered.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Able to provide informed consent to participate in the study * Able to perform physical activities such as cycling * 18-40 years old * BMI\<27 * Practice of moderate intensity aerobic physical activity less than 150 minutes per week
Exclusion criteria
* Hypertension * Diabetes * Cardiovascular disease * Subjects with pacemakers, and/or implantable cardioverter-defibrillators * History of asthma with active symptomatology in the past year, pulmonary disease or use of inhalers * Physical disability, neurological and/or psychological disorder that precludes safe and adequate testing * Conditions that may impair the ability to feel pain * Mental impairment with limited ability to cooperate * Uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, or hyperthyroidism * Pregnancy or trying to become pregnant in the next 6 months * History of alcohol or drug abuse within the past 6 months as self-reported * Epilepsy * Suffering from severe depression (with a score \>30 in the Beck Depression Inventory) * History of unexplained fainting spells as self-reported * Head injury resulting in more than a momentary loss of consciousness * History of neurosurgery as self-reported * Use of antiepileptic and/or hypnotic medications like carbamazepine, valproate acid, gabapentin, zolpidem, etc. * Use of medication with potential cardiovascular influence * Active smoker, or history of smoking in the last 6 months * Skin lesion or open wounds around or in area of electrode application * Tattoos in upper limb or along the nerve tract
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PPT | Between Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2) | Pain threshold as measured by Pressure Pain Threshold (PPT) between Visits 2 and 3 (active stimulation and sham, order randomized). |
| DNIC | Between Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2) | Pain threshold as measured by Descending Noxious Inhibitory Control (DNIC) between Visits 2 and 3 |
| VAS | Between Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2) | Pain threshold as measured by Visual Analogue Scale (VAS) between Visits 2 and 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to fatigue | Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2) | Time to fatigue as measured by total cycling time at 80% of peak power. |
| Perception of physical exertion | Visit 1, 2, and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2) | Perception of physical exertion as measured by the 6-20 Borg Scale |
| EEG | Visit 2 and Vist 3...where Visit 1 = baseline, Visit 2 = stimulation visit, sham or active (about 2 days from baseline), and Visit 3 = stimulation visit, sham or active (about 1 week from visit 2) | Spontaneous oscillatory brain activity as measured by EEG using a wireless Enobio system (Neuroelectrics, Barcelona, Spain). |
| Respiratory rate | Visit 1, 2, and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2) | Respiratory rate as measured by a belt transducer |
| Heart rate | Visit 1, 2, and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2) | Heart rate as measured by a standard electrocardiogram |
| Attention Task | Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2) | Cognitive Performance (for attention) as measured by the Attention Network Task |
| N Back test | Visit 2 and 3...where Visit 1 = baseline, Visit 2 = stimulation visit, randomly assigned sham or active (about 2 days from baseline), and Visit 3 = other stimulation visit, sham or active - one not received before (about 1 week from visit 2) | Cognitive Performance (for working memory) as measured by the |
Countries
United States
Outcome results
None listed