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Healthy ParticipantsNCT02672371

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

A study testing Active eMNS in people with Healthy Participants, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Active eMNS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jun 2017to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Spaulding Rehabilitation Network Research Institute

    Charlestown, Massachusetts, 02129

Other trials in United States

About this study

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

Being tested
Active eMNS, Sham eMNS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active eMNSDevice

    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 eMNSDevice

    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.

Study groups in NCT02672371
Study groupRoleWhat they receive
active eMNSExperimentalSubjects with receive active eMNS for 20 minutes.
Receives: Device: Active eMNS
sham eMNSSham comparatorSubjects with receive sham eMNS for 20 minutes.
Receives: Device: Sham eMNS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PPT

    Pain threshold as measured by Pressure Pain Threshold (PPT) between Visits 2 and 3 (active stimulation and sham, order randomized).

    Measured: 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)

  2. DNIC

    Pain threshold as measured by Descending Noxious Inhibitory Control (DNIC) between Visits 2 and 3

    Measured: 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)

  3. VAS

    Pain threshold as measured by Visual Analogue Scale (VAS) between Visits 2 and 3

    Measured: 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)

  1. EEG

    Spontaneous oscillatory brain activity as measured by EEG using a wireless Enobio system (Neuroelectrics, Barcelona, Spain).

    Measured: 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)

  2. Attention Task

    Cognitive Performance (for attention) as measured by the Attention Network Task

    Measured: 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)

  3. N Back test

    Cognitive Performance (for working memory) as measured by the

    Measured: 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)

  4. Time to fatigue

    Time to fatigue as measured by total cycling time at 80% of peak power.

    Measured: 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)

  5. Perception of physical exertion

    Perception of physical exertion as measured by the 6-20 Borg Scale

    Measured: 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)

  6. Heart rate

    Heart rate as measured by a standard electrocardiogram

    Measured: 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)

  7. Respiratory rate

    Respiratory rate as measured by a belt transducer

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2016 (estimated)
  2. Study startJun 2017 (estimated)
  3. Primary completionSep 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Why it stopped: Study was not approved for the IRB; we then had no funds to reapply

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02672371
Sponsor's protocol ID
2015P002574
Status last verified
Apr 2020
First submitted
8 Dec 2015
Last updated
24 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Active eMNS in people with Healthy Participants, run by Spaulding Rehabilitation Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PPT (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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02672371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.

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