The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults

Study Overview
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Brief Summary
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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

Official Title
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The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults

Conditions
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Healthy Participants

Intervention / Treatment
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* Device: Active eMNS
* Device: Sham eMNS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active eMNS<br>Subjects with receive active eMNS for 20 minutes. | Device: Active eMNS<br>* 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.<br>|
| Sham Comparator: sham eMNS<br>Subjects with receive sham eMNS for 20 minutes. | Device: Sham eMNS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPT | Pain threshold as measured by Pressure Pain Threshold (PPT) between Visits 2 and 3 (active stimulation and sham, order randomized). | 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) | 
| DNIC | Pain threshold as measured by Descending Noxious Inhibitory Control (DNIC) between Visits 2 and 3 | 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) | 
| VAS | Pain threshold as measured by Visual Analogue Scale (VAS) between Visits 2 and 3 | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG | Spontaneous oscillatory brain activity as measured by EEG using a wireless Enobio system (Neuroelectrics, Barcelona, Spain). | 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) | 
| Attention Task | Cognitive Performance (for attention) as measured by the Attention Network 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) | 
| N Back test | Cognitive Performance (for working memory) as measured by the | 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 | Time to fatigue as measured by total cycling time at 80% of peak power. | 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) | 
| Perception of physical exertion | Perception of physical exertion as measured by the 6-20 Borg Scale | 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 | Heart rate as measured by a standard electrocardiogram | 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 | Respiratory rate as measured by a belt transducer | 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) |