The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Fase
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Charlestown, Massachusetts, Stati Uniti, 02129
- Spaulding Rehabilitation Network Research Institute
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore fittizio: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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PPT
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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EEG
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Inizio studio
Completamento primario (Anticipato)
Completamento primario
Completamento dello studio (Anticipato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 2015P002574
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