Brain Injuries Clinical Trial
Official title:
Language Assessment and Treatment Following Acquired Brain Injury
Verified date | November 2019 |
Source | University of Nebraska Lincoln |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
People with acquired brain injury (ABI) often experience persistent language challenges that are subtle in nature and not readily observable to others. These challenges can have substantial negative effects on vocational and social endeavors despite their subtlety. Even though these challenges are prevalent in the ABI population, limited methods exist for quantifying and remediating them. The two purposes of Phase I of this research are to (a) explore methods of using event related potential (ERP) recordings to quantify language processing differences between people with and without ABI and (b) correlate behavioral observations from language tests with ERP findings. The purpose of Phase II is to explore the use of game-based, group activities as an intervention for people with ABI who experience word-retrieval challenges. The purpose of Phase III is to collect post-intervention data for comparison with Phase I data and provide evidence about the effectiveness of the intervention program.
Status | Completed |
Enrollment | 7 |
Est. completion date | November 14, 2019 |
Est. primary completion date | November 14, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Adults with acquired brain injury (ABI): - Have sustained a mild, moderate, or severe ABI - Have concerns about language-related challenges following ABI - Adults without ABI - Have no history of ABI, other neurological impairment, or learning challenges - Match a participant with ABI on age, gender, and education Exclusion Criteria: - Do not speak English as a primary language |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Lincoln | Lincoln | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska Lincoln |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time spent performing specific intervention activities | The investigators will measure the amount of time each participant chooses to spend engaging in specific game activities during the Phase II intervention sessions. | Weeks two through nine of participant enrollment | |
Primary | Change in amplitude of N400 event related potential (ERP) as measured in microvolts. | ERP recordings will be taken while a participant performs naming tasks. The average amplitude of N400 will be measured in microvolts across trials. | The second day of participant enrollment and 10 weeks later on the last day of participant enrollment | |
Secondary | Total raw score on Test of Adolescent/Adult Word Retrieval | A participant will perform the Test of Adolescent/Adult Word Retrieval. Scoring will be done in accordance with the standardized procedures outlined in the manual. Possible scores range from 0-107, with higher scores indicating better performance than lower scores. | First day of participant enrollment | |
Secondary | Executive Functions Domain score on the Cognitive Linguistic Quick Test | A participant will perform the Cognitive Linguistic Quick Test. Scoring will be done in accordance with the standardized procedures outlined in the manual. Executive Functions Domain scores are the sum of the scores obtained on the Symbol Trails task (range: 0-10), the Generative Naming task (range: 0-9), the Mazes task (range: 0-8), and the Design Generation task (range: 0-13). Possible Executive Function Domain scores range from 0 to 40, with higher scores indicating better performance than lower scores. Scores from 0-15 correspond with a severity rating of 1; scores from 16-19 correspond with a severity rating of 2; scores from 20-23 correspond with a severity rating of 3; and scores from 24-40 correspond with a severity rating of 4 and performance within normal limits. | First day of participant enrollment | |
Secondary | Visuospatial Domain score on the Cognitive Linguistic Quick Test | A participant will perform the Cognitive Linguistic Quick Test. Scoring will be done in accordance with the standardized procedures outlined in the manual. Visuospatial Domain scores are the sum of the scores obtained on the Symbol Cancellation task (range: 0-12) times 2, the Symbol Trails task (range: 0-10) times 2, the Design Memory task (range: 0-6) times 4, the Mazes task (range: 0-8) times 3, and the Design Generation task (range: 0-13) times 1. Possible Visuospatial Domain scores range from 0 to 105, with higher scores indicating better performance than lower scores. Scores from 0-41 correspond with a severity rating of 1; scores from 42-51 correspond with a severity rating of 2; scores from 52-81 correspond with a severity rating of 3; and scores from 82-105 correspond with a severity rating of 4 and performance within normal limits. | First day of participant enrollment | |
Secondary | Trials 1-5 Free Recall Total Correct on the California Verbal Learning Test - II | A participant will perform the California Verbal Learning Test. Scoring will be done in accordance with the standardized procedures outlined in the manual. Raw scores range from 0 to 100. Higher total correct scores indicate better performance than lower total correct scores. | First day of participant enrollment | |
Secondary | Change in number of self-reported instances of word retrieval difficulty | A participant will engage in a conversational interaction with the researcher. The participant will press a button each time he/she experiences difficulty retrieving a word. The number of instances of self-reported word retrieval difficulty will be tallied. | The second day of participant enrollment and 10 weeks later on the last day of participant enrollment | |
Secondary | Amplitude of N400 event related potential (ERP) as measured in microvolts. | ERP recordings will be taken while a participant performs naming tasks. The average amplitude of N400 will be measured in microvolts across trials. | First day of participant enrollment |
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