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

Primary Purpose

Healthy Participants

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active eMNS
Sham eMNS
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Participants

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Network Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active eMNS

sham eMNS

Arm Description

Subjects with receive active eMNS for 20 minutes.

Subjects with receive sham eMNS for 20 minutes.

Outcomes

Primary Outcome Measures

PPT
Pain threshold as measured by Pressure Pain Threshold (PPT) between Visits 2 and 3 (active stimulation and sham, order randomized).
DNIC
Pain threshold as measured by Descending Noxious Inhibitory Control (DNIC) between Visits 2 and 3
VAS
Pain threshold as measured by Visual Analogue Scale (VAS) between Visits 2 and 3

Secondary Outcome Measures

EEG
Spontaneous oscillatory brain activity as measured by EEG using a wireless Enobio system (Neuroelectrics, Barcelona, Spain).
Attention Task
Cognitive Performance (for attention) as measured by the Attention Network Task
N Back test
Cognitive Performance (for working memory) as measured by the
Time to fatigue
Time to fatigue as measured by total cycling time at 80% of peak power.
Perception of physical exertion
Perception of physical exertion as measured by the 6-20 Borg Scale
Heart rate
Heart rate as measured by a standard electrocardiogram
Respiratory rate
Respiratory rate as measured by a belt transducer

Full Information

First Posted
December 8, 2015
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02672371
Brief Title
The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults
Official Title
The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not approved for the IRB; we then had no funds to reapply
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active eMNS
Arm Type
Experimental
Arm Description
Subjects with receive active eMNS for 20 minutes.
Arm Title
sham eMNS
Arm Type
Sham Comparator
Arm Description
Subjects with receive sham eMNS for 20 minutes.
Intervention Type
Device
Intervention Name(s)
Active eMNS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham eMNS
Intervention Description
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.
Primary Outcome Measure Information:
Title
PPT
Description
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)
Title
DNIC
Description
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)
Title
VAS
Description
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)
Secondary Outcome Measure Information:
Title
EEG
Description
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)
Title
Attention Task
Description
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)
Title
N Back test
Description
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)
Title
Time to fatigue
Description
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)
Title
Perception of physical exertion
Description
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)
Title
Heart rate
Description
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)
Title
Respiratory rate
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD, PhD, MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Network Research Institute
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

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

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