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

23. April 2020 aktualisiert von: 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

Studienübersicht

Status

Zurückgezogen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Massachusetts
      • Charlestown, Massachusetts, Vereinigte Staaten, 02129
        • Spaulding Rehabilitation Network Research Institute

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 40 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: active eMNS
Subjects with receive active eMNS for 20 minutes.
Gerät: 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.
Schein-Komparator: sham eMNS
Subjects with receive sham eMNS for 20 minutes.
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PPT
Zeitfenster: 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)
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)
DNIC
Zeitfenster: 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)
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)
VAS
Zeitfenster: 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)
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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
EEG
Zeitfenster: 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)
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)
Attention Task
Zeitfenster: 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)
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)
N Back test
Zeitfenster: 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)
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)
Time to fatigue
Zeitfenster: 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)
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)
Perception of physical exertion
Zeitfenster: 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)
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)
Heart rate
Zeitfenster: 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)
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)
Respiratory rate
Zeitfenster: 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)
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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Spaulding Rehabilitation Hospital

Ermittler

  • Hauptermittler: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. Juni 2017

Primärer Abschluss (Voraussichtlich)

1. September 2018

Studienabschluss (Voraussichtlich)

1. September 2018

Studienanmeldedaten

Zuerst eingereicht

8. Dezember 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

2. Februar 2016

Zuerst gepostet (Schätzen)

3. Februar 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. April 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. April 2020

Zuletzt verifiziert

1. April 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2015P002574

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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