- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02672371
The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults
23 aprile 2020 aggiornato da: 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
Panoramica dello studio
Stato
Ritirato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
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
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 40 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
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
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: active eMNS
Subjects with receive active eMNS for 20 minutes.
|
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.
|
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
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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)
|
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
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)
|
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
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)
|
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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
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)
|
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
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)
|
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
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)
|
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
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
1 giugno 2017
Completamento primario (Anticipato)
1 settembre 2018
Completamento dello studio (Anticipato)
1 settembre 2018
Date di iscrizione allo studio
Primo inviato
8 dicembre 2015
Primo inviato che soddisfa i criteri di controllo qualità
2 febbraio 2016
Primo Inserito (Stima)
3 febbraio 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 aprile 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 aprile 2020
Ultimo verificato
1 aprile 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2015P002574
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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