Clinical trial NCT02672371: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy Participants
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


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

Primary outcomes:
measure: PPT
timeFrame: 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)
measure: DNIC
timeFrame: 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)
measure: VAS
timeFrame: 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:
measure: EEG
timeFrame: 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)
measure: Attention Task
timeFrame: 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)
measure: N Back test
timeFrame: 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)
measure: Time to fatigue
timeFrame: 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)
measure: Perception of physical exertion
timeFrame: 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)
measure: Heart rate
timeFrame: 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)
measure: Respiratory rate
timeFrame: 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)
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Network Research Institute
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: