Speed of Processing Training to Improve Cognitive Functioning and Driving Performance in Head and Neck Cancer Survivors
調査の概要
詳細な説明
If participants agree to participate in the study by signing the informed consent, participants will be randomly assigned (similar to flipping a coin) to one of the two video game cognitive exercise groups. The only difference between these two groups is the intensity of training on reaction time to video game events.
participants will complete questionnaires (socio-demographic information, four short cognitive assessments) and a driving assessment using a high-fidelity motion-based virtual reality driving simulator in the UAB Driver Simulation Lab at baseline. After completing the baseline cognitive and driving evaluations, participants will receive an electronic tablet loaded with access to the assigned video game program and a workbook with instructions and explanations. A staff member will assist participants in logging in, demonstrate the video game cognitive exercises, and show participants how to play a trial game session.
At home, participants will complete 30-minute video game-based cognitive exercises twice weekly for 10 weeks (20 sessions, totaling 10 hours). The software will automatically record the actual session duration. One week after the baseline appointment, the staff will contact participants to address any technical problems. The staff will then contact participants monthly to monitor progress and answer study-related questions.
After the 10-week video game cognitive exercise program, participants will be invited to the UAB Driver Simulation Lab to complete the four short cognitive assessments and a driving assessment as participants did 10 weeks ago.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hon Yuen
- 電話番号：12059346301
- メール：yuen@uab.edu
研究連絡先のバックアップ
- 名前：Adrian Smith
- 電話番号：2059348931
- メール：adrian02@uab.edu
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham
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コンタクト：
- Yuen
- 電話番号：2059345266
- メール：honkeungyuen@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- confirmed HNC diagnosis
- aged ≥ 18 years of all racial, ethnic, and sex/gender categories
- ≥ 6 months post radiation or chemoradiation
- self-reported CRCI, defined as a score of ≥ 60 in the FACT-Cog Perceived Cognitive Impairment subscale
- thyroid-stimulating hormone levels within normal limits
- visual acuity of at least 20/40 using a Snellen eye chart
- functional peripheral vision as indicated by the confrontation field test
- functional hearing sufficient to engage in daily conversation in English for ≥ 15 minutes
- intact lower extremity function (Rapid Pace Walk test ≤ 9 sec)
- stable home internet
- sufficient English proficiency to read and understand informed consent materials
Exclusion Criteria:
- significant neurologic or psychiatric comorbidities, including psychotic disorders, bipolar disorders, Alzheimer's disease or related dementias, developmental disorders, seizure disorders, vestibular disorders, prior brain tumor or brain surgery, or poorly controlled metabolic disease
- current use of antipsychotic or mood-stabilizing medications due to potential effects on driving performance
- anticipated life expectancy of < 6 months based on physician prognosis.
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
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：Speed of Processing Training
The training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present.
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The training is the game-based cognitive exercises that involve the speed and accuracy of visual information processing and enhance divided attention between central and peripheral stimuli and among peripheral stimuli when distractors are present.
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偽コンパレータ：Home-Based Sham Training
The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.
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The sham condition includes five interactive video game activities that are self-paced, non-adaptive, and not designed to affect processing speed.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Useful Field of View
時間枠：change from baseline in speed of processing at 10 weeks
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Useful Field of View (UFOV) examines visual attention and memory that require rapid recognition and response to simultaneous demands in both the central and peripheral visual fields.
The test consists of four increasingly complex subtests.
In each subtest, stimulus presentations ranging from 17-500 milliseconds are displayed to determine the speed at which visual information is processed.
In each subtest, a double staircase method is used to determine the presentation speed at which participants correctly complete the task 75% of the time.
Lower scores (fewer milliseconds to correctly perceive the target) reflect faster SOP.
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change from baseline in speed of processing at 10 weeks
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協力者と研究者
捜査官
- 主任研究者：Hon Yuen、University of Alabama at Birmingham
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
その他の研究ID番号
- IRB-300017007
- UAB (その他の識別子：UAB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
米国FDA規制機器製品の研究
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。