A Health Game Intervention for Cancer and Post-ICU Patients Suffering From Acute Cognitive Impairment
A Health Game Intervention for Cancer and Post-ICU Patients Suffering From Acute Cognitive Impairment: A Clinical Study to Assess a New Form of Brain Stimulation Therapy With the Potential to Improve Synaptic Plasticity
調査の概要
詳細な説明
After the completion of a usability study, a two-arm, randomized parallel-group efficacy pilot study will be executed with adult brain cancer patients to estimate cognitive improvements using 3 cognitive assessment measures. Arms will include an experimental group (intervention) and the non-gameplay attention group (control).
Experimental group: estimate approximately 10 hours of game play (over 4 weeks) and 1-2 hours of cognitive survey testing will be needed
Control group: It is estimated approximately 10 hours of Word-Search and Crossword Puzzle play (over 4 weeks) and 1-2 hours of cognitive survey testing will be needed.
Patient total duration of the intervention will be four weeks (3X per week) starting approximately one to two weeks after the conclusion of all cancer treatment (chemo and radiation therapy). Depending on the patients' ability/comfort level, we will determine if they are able to use the VR headset and hand controls.
The 3 cognitive scales:
- Hopkins Verbal Learning and Memory test
- Controlled Oral Word Association test (verbal fluency/exec. functions)
- Trail Making test (processing speed, executive function, visual perception)
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Kentucky
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Lexington、Kentucky、アメリカ、40536-0093
- Markey Cancer Center, Neuro Oncology Outpatient Clinic
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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:
Inclusion criteria of our study are as follows: (1) age 18 years or older, (2) English speaking, (3) Completion of all chemo and radiation therapy and surgical procedures, (4) physical, cognitively, and emotionally able to wear the VR game headset or seat with personal computer flat screen, (5) able to provide consent or through a legally authorized representative, (6) available to play the game three times per week for four consecutive weeks, either in the outpatient clinics or in a location near their home, with the support to provide them transportation to either location and (7) own a cell phone by which they can be reached to make arrangement for testing. Race and gender are not conditions for inclusion in this pilot study.
Exclusion Criteria:
Patients are excluded from our study if any of the following conditions are present: (1) history of mental illnesses and other neurodegenerative diseases such as Alzheimer's disease, vascular dementia, or any other form of advanced neurodegenerative or neuro-cognitive diseases, (2) severe psychiatric illness which is not well controlled, (3) suspected or confirmed drug intoxication/overdose; (5) acute neurologic injury such as traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery, (6) uncorrected hearing or vision impairment including legal blindness, (7) incarcerated at the time of study enrollment, (8) enrolled in another clinical trial which does not permit co-enrollment, or (9) any medical condition precluding safe use of VR headset and hand control technology or physical use of personal computer flat screen and touch pads.
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：VR cognitive training platform
The virtual reality cognitive training platform is specifically designed for mild cognitive impairment populations.
The system, referred to as: Virtual Reality-Cognitive Rehabilitation Training (VR-CRT) offers advantages over traditional computerized cognitive training programs due to its immersive virtual reality environment with 81 embedded attention exercises.
VR-CRT is a scenario goal-driven (game) framework that rewards patients with points and feedback at the end of each module to promote engagement and incentivize use.
Automated (backend) game score tracking encourages aspirational behavior and goal setting with each module completion.
VR-CRT was designed with three interconnecting virtual reality environments/levels, each with their own (progressively demanding) attention exercises, along with the ability for new training module integration, i.e., plug-ins to maintain game novelty and challenge.
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See description above.
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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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Hopkins Verbal Learning and Memory test
時間枠：4 weeks
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The test consists of a 12-item word list, composed of four words from each of the three semantic categories.
The participant listens and memorizes the words as the examiner reads the complete word list of 12 items.
This is followed by the participant's attempt to recite back the list of words in any order.
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4 weeks
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Controlled Oral Word Association
時間枠：4 weeks
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This is a verbal fluency test.
Participants are instructed to produce as many words as possible in a 1-minute time-period that begin with the letter cues C, F and L, which were originally selected for their increasing difficulty.
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4 weeks
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Trail Making A-B
時間枠：4 weeks
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This test consists of 25 circles each distributed over a sheet of paper.
In Part A, the circles are numbered 1-25 and, in Part B, the circles include both numbers 1-13 and letters A-L.
With Part A, the participant is instructed to draw lines to connect the numbers in ascending order and in Part B, the participant is instructed to draw lines to connect the circles in an ascending pattern, while alternating between the numbers and letters (i.e., 1-A, 2-B, 3-C, etc.)
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4 weeks
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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 (実際)
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 (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
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。