Mild Cognitive Impairment
Conditions
Brief summary
Millions of patients each year suffer from acute cognitive impairment caused by traumatic brain injury, stroke, Parkinson's disease, etc. Despite increasing incidences and morbidity, effective pharmacological interventions continue to show a lack of improvement for brain cancer patients. Studies thus far have shown that non-pharmacological interventions have contributed to early success in addressing some forms of cognitive impairment for patients with cognitive dysfunction. We have built a phase-one fully functioning game Hometown Bound that offers cognitive challenges to patients. The aim of this study is to observe for measured improvement of cognitive function among brain cancer patients, which will be validated by the four cognitive scales, measuring efficacy. The first three scales measure patient baseline impairment before and after game play.
Detailed description
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: 1. Hopkins Verbal Learning and Memory test 2. Controlled Oral Word Association test (verbal fluency/exec. functions) 3. Trail Making test (processing speed, executive function, visual perception)
Interventions
DEVICEVR cognitive training platform
See description above.
Sponsors
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hopkins Verbal Learning and Memory test | 4 weeks | 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. |
| Controlled Oral Word Association | 4 weeks | 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. |
| Trail Making A-B | 4 weeks | 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.) |
Countries
United States
Outcome results
None listed