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

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

Study Overview

• Status: Withdrawn
• Conditions: Healthy Participants
• Intervention / Treatment: Device: Active eMNS; Device: Sham eMNS

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Network Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active eMNS; Subjects with receive active eMNS for 20 minutes.	Device: Active 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.
Sham Comparator: sham eMNS; Subjects with receive sham eMNS for 20 minutes.	Device: Sham 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Investigators: Principal Investigator: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 2015P002574

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No