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

Mass General Brigham logo

Mass General Brigham

Status

Withdrawn

Conditions

Healthy Participants

Treatments

Device: Active eMNS
Device: Sham eMNS

Study type

Interventional

Funder types

Other

Identifiers

NCT02672371
2015P002574

Details and patient eligibility

About

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

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

0 participants in 2 patient groups

active eMNS
Experimental group
Description:
Subjects with receive active eMNS for 20 minutes.
Treatment:
Device: Active eMNS
sham eMNS
Sham Comparator group
Description:
Subjects with receive sham eMNS for 20 minutes.
Treatment:
Device: Sham eMNS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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