The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults
Not Applicable
Withdrawn
- Conditions
- Healthy Participants
- Interventions
- Device: Active eMNSDevice: Sham eMNS
- Registration Number
- NCT02672371
- Lead Sponsor
- Spaulding Rehabilitation Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description active eMNS Active eMNS Subjects with receive active eMNS for 20 minutes. sham eMNS Sham eMNS Subjects with receive sham eMNS for 20 minutes.
- Primary Outcome Measures
Name Time Method 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
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
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).
- Secondary Outcome Measures
Name Time Method 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
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).
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
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
Trial Locations
- Locations (1)
Spaulding Rehabilitation Network Research Institute
🇺🇸Charlestown, Massachusetts, United States