The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults
23 april 2020 bijgewerkt door: Felipe Fregni, Spaulding Rehabilitation Hospital
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
Studie Overzicht
Toestand
Ingetrokken
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Massachusetts
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Charlestown, Massachusetts, Verenigde Staten, 02129
- Spaulding Rehabilitation Network Research Institute
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 40 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: active eMNS
Subjects with receive active eMNS for 20 minutes.
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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.
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Sham-vergelijker: sham eMNS
Subjects with receive sham eMNS for 20 minutes.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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PPT
Tijdsspanne: 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)
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Pain threshold as measured by Pressure Pain Threshold (PPT) between Visits 2 and 3 (active stimulation and sham, order randomized).
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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)
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DNIC
Tijdsspanne: 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)
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Pain threshold as measured by Descending Noxious Inhibitory Control (DNIC) between Visits 2 and 3
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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)
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VAS
Tijdsspanne: 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)
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Pain threshold as measured by Visual Analogue Scale (VAS) between Visits 2 and 3
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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)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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EEG
Tijdsspanne: 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)
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Spontaneous oscillatory brain activity as measured by EEG using a wireless Enobio system (Neuroelectrics, Barcelona, Spain).
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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)
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Attention Task
Tijdsspanne: 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)
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Cognitive Performance (for attention) as measured by the Attention Network Task
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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)
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N Back test
Tijdsspanne: 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)
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Cognitive Performance (for working memory) as measured by the
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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)
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Time to fatigue
Tijdsspanne: 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)
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Time to fatigue as measured by total cycling time at 80% of peak power.
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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)
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Perception of physical exertion
Tijdsspanne: 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)
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Perception of physical exertion as measured by the 6-20 Borg Scale
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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)
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Heart rate
Tijdsspanne: 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)
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Heart rate as measured by a standard electrocardiogram
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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)
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Respiratory rate
Tijdsspanne: 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)
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Respiratory rate as measured by a belt transducer
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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)
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Verwacht)
1 juni 2017
Primaire voltooiing (Verwacht)
1 september 2018
Studie voltooiing (Verwacht)
1 september 2018
Studieregistratiedata
Eerst ingediend
8 december 2015
Eerst ingediend dat voldeed aan de QC-criteria
2 februari 2016
Eerst geplaatst (Schatting)
3 februari 2016
Updates van studierecords
Laatste update geplaatst (Werkelijk)
24 april 2020
Laatste update ingediend die voldeed aan QC-criteria
23 april 2020
Laatst geverifieerd
1 april 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2015P002574
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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