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

NCT02672371 | Withdrawn

• 1 other identifier: 2015P002574
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

Study Arms (2)

active eMNS

EXPERIMENTAL

Subjects with receive active eMNS for 20 minutes.

Device: Active eMNS

sham eMNS

SHAM COMPARATOR

Subjects with receive sham eMNS for 20 minutes.

Device: Sham eMNS

Interventions

Active eMNS DEVICE

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.

active eMNS

Sham eMNS DEVICE

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.

sham eMNS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide informed consent to participate in the study
• Able to perform physical activities such as cycling
• years old
• BMI\<27
• Practice of moderate intensity aerobic physical activity less than 150 minutes per week

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129, United States

Location

Study Officials

• Felipe Fregni, MD, PhD, MPH

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: February 3, 2016
• Study Start: June 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)