An interventional study of Active eMNS and Sham eMNS in Healthy Participants, sponsored by Spaulding Rehabilitation Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Other
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
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
Browse Fatigue studies →Spaulding Rehabilitation Hospital is the lead sponsor of 114 studies on the registry; 26 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects with receive active eMNS for 20 minutes.
Device: Active eMNS
Subjects with receive sham eMNS for 20 minutes.
Device: Sham 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.
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.
PPT
Pain threshold as measured by Pressure Pain Threshold (PPT) between Visits 2 and 3 (active stimulation and sham, order randomized).
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)
DNIC
Pain threshold as measured by Descending Noxious Inhibitory Control (DNIC) between Visits 2 and 3
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)
VAS
Pain threshold as measured by Visual Analogue Scale (VAS) between Visits 2 and 3
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)
EEG
Spontaneous oscillatory brain activity as measured by EEG using a wireless Enobio system (Neuroelectrics, Barcelona, Spain).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
This study is withdrawn, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Spaulding Rehabilitation Hospital