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

NCT ID: NCT02672371

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2018-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

active eMNS

Subjects with receive active eMNS for 20 minutes.

Group Type: EXPERIMENTAL

Active eMNS

Intervention Type: 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.

sham eMNS

Subjects with receive sham eMNS for 20 minutes.

Group Type: SHAM_COMPARATOR

Sham eMNS

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, United States

Countries

United States

Other Identifiers

2015P002574

Identifier Type: -

Identifier Source: org_study_id