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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02672371
• Other study ID #: 2015P002574
• Status: Withdrawn
• Phase: N/A
• Start date: June 2017
• Est. completion date: September 2018

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Healthy Participants

Intervention

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 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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Network Research Institute	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)