The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Participants
- Sponsor
- Spaulding Rehabilitation Hospital
- Locations
- 1
- Primary Endpoint
- VAS
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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
Investigators
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital
Eligibility Criteria
Inclusion Criteria
- •Able to provide informed consent to participate in the study
- •Able to perform physical activities such as cycling
- •18-40 years old
- •Practice of moderate intensity aerobic physical activity less than 150 minutes per week
Exclusion Criteria
- •Hypertension
- •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
Outcomes
Primary Outcomes
VAS
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))