Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Sport Concussion Assessment - Test Stability and Effect of Concussion
Mild traumatic brain injury (mTBI), also known as concussion, occurs commonly in sport. Despite ongoing research, there is no highly sensitive clinical test for cognitive function. This makes the clinical diagnosis of concussion particularly difficult as the clinical presentation of concussion is highly variable with symptoms often evolving over time. Given the variability in concussion presentations, there is no single test that can diagnose a concussion. Current recommendations are that sports medicine providers apply a multifaceted concussion assessment battery that combines subjective symptoms, motor control and cognitive assessment.
This investigation is designed to evaluate the clinical utility of ElMindA's BNA scores in detecting and managing concussive injuries. This study will establish the reliability of BNA™ scores over clinically relevant assessment intervals and investigate the effect of SRC and sub-concussive head impacts on BNA scores.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48105
- Michigan NeuroSport Concussion Program
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Phase 1: gender-balanced groups of 30 healthy high school (14-17 years old) and 30 healthy college aged (18-26 years old) individuals who participate in non-contact sports Phase 2a: 30 high school and/or collegiate athletes aged 14-26 years with concussion and 30 matched control athletes.
Phase 2b: at least 30 high school and/or collegiate contact sport athletes aged 14-26 years whose head impacts are monitored during games and practices.
説明
Phase 1:
Inclusion Criteria:
- Aged 14-26 years
- Enrolled in a recognized high school or college
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self)
- Currently participate in a non-contact sport.
- Member of an organized athletic team or regularly train for and participate in independent athletic contests during at least one sports season.
- Right handed subject
Exclusion Criteria:
- Currently participate in a contact sport.
- Bald or has dread locks/long and thick hair.
- Any diagnosed psychiatric disorder
- History of CNS injury or disease
- Any neuropsychological disorders
- History of learning disability.
- History of any medication affecting CNS.
- Active head lice infection, open scalp wound, deafness or/and blindness.
- Sustained a diagnosed concussion within the previous 6 months
Phase 2a:
Inclusion Criteria:
- Aged 14-26 years.
- For Arm 1: Within 1 week post-concussion (sports-related).
- For Arm 1: Currently symptomatic
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
- Member of an organized athletic team or regularly train.
- Enrolled in a high school or college.
Exclusion Criteria:
- Bald or has dread locks/long and thick hair.
- Current or history of ADHD.
- Active head lice infection, open scalp wound, deafness or/and blindness.
- Sustained a concussion within the past 6 months.
- Current or history of moderate or severe TBI, any brain injury with positive neuroimaging findings, or brain surgery.
Phase 2b:
Inclusion Criteria:
- Aged 14-26 years.
- Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).
- Member of a contact sport team which carries out head impact monitoring over the course of the playing season.
- Enrolled in a high school or college.
Exclusion Criteria:
- Bald or has dread locks/long and thick hair.
- Current or history of ADHD.
- Active head lice infection, open scalp wound, deafness or/and blindness.
- Sustained a concussion within the past 6 months.
- Current or history of moderate or severe TBI, any brain injury with positive neuroimaging findings, or brain surgery.
- Any diagnosed psychiatric disorder.
- History of CNS injury or disease
- Any neuropsychological disorders.
- History of learning disability.
- History of any medication affecting CNS.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
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Phase I - Normative
Athletes who does not participate in contact sport with no recent concussion
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Phase IIa - Concussed
Athletes with recent concussion
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Phase IIa - Control
Athletes with no recent concussion
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Phase IIb - Athletes
Athletes with no recent concussion
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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 |
時間枠 |
|---|---|
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Change of Brain Network Activation(BNA™)Scores
時間枠：P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
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P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Correlation Of The Change In BNA™ Scores To Clinical Diagnstic
時間枠：P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
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P.I - days 0 , 7, 42, 365 ; P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
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Correlation Of The Change In BNA™ Scores To Neurocognitive Tests Scroes
時間枠：P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
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P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
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Correlation Of The Change In BNA™ Scores To Reaction Time Scores
時間枠：P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
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P.IIa - 1 week of injury, 48 hours of symptom resolution, 48 hours of clearance to sport, 1 month after symptom resolution; P.IIb - baseline, mid season, 30 days of completion of the season
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
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