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

2020年4月23日 更新者: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

調査の概要

状態

引きこもった

研究の種類

介入

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Massachusetts
      • Charlestown、Massachusetts、アメリカ、02129
        • Spaulding Rehabilitation Network Research Institute

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~40年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:クロスオーバー割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
偽コンパレータ:sham eMNS
Subjects with receive sham eMNS for 20 minutes.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
PPT
時間枠: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
時間枠: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
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
EEG
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Felipe Fregni, MD, PhD, MPH、Spaulding Rehabilitation Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2017年6月1日

一次修了 (予想される)

2018年9月1日

研究の完了 (予想される)

2018年9月1日

試験登録日

最初に提出

2015年12月8日

QC基準を満たした最初の提出物

2016年2月2日

最初の投稿 (見積もり)

2016年2月3日

学習記録の更新

投稿された最後の更新 (実際)

2020年4月24日

QC基準を満たした最後の更新が送信されました

2020年4月23日

最終確認日

2020年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2015P002574

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Active eMNSの臨床試験

3
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