The Effects of Sensory Training On Pain Modulation, Cognition and Time to Fatigue in Healthy Adults
23 de abril de 2020 atualizado por: 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
Visão geral do estudo
Status
Retirado
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Massachusetts
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Charlestown, Massachusetts, Estados Unidos, 02129
- Spaulding Rehabilitation Network Research Institute
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 40 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Falso: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PPT
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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EEG
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de junho de 2017
Conclusão Primária (Antecipado)
1 de setembro de 2018
Conclusão do estudo (Antecipado)
1 de setembro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
8 de dezembro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de fevereiro de 2016
Primeira postagem (Estimativa)
3 de fevereiro de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de abril de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de abril de 2020
Última verificação
1 de abril de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2015P002574
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
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