An interventional study of Anomia treatment in Brain Injuries, sponsored by University of Nebraska Lincoln. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-15.
Sponsored by University of Nebraska Lincoln · Not applicable, Interventional, and Treatment
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.
Phase I: Phase I participants will engage in two sets of activities: (a) standardized and informal language and cognitive measures and (b) a series of language and cognitive activities performed during the collection of event related potential (ERP) recordings. Standardized language measures will include the: (a) Test of Adolescent/Adult Word Retrieval, (b) Cognitive Linguistic Quick Test, and (c) California Verbal Learning Test. Informal measures will include a conversational interaction about a participant's language difficulties and a topic of his/her choosing. During the conversational interaction, participants will press a button each time they experience difficulty retrieving a word.
ERPs measure electrical signals from the brain using a soft net of woven electrodes placed on a participant's head. Before the session, the investigators will soak a net in a saline (salt water) solution. The recording electrodes will be placed on the participant's scalp. The investigators will record ERPs while the participant completes the following tasks:
Phase II: Only people with acquired brain injury (ABI) will participate in Phase II activities. Phase II participants will attend two-hour, group intervention sessions one day per week for eight weeks. Participants will engage in multiple word game activities throughout each intervention session. Games will include Facts in Five, Anomia, Boggle, and Bananagrams as well as variations on these, as appropriate. Data collection during these sessions will be limited to a list of activities in which a participant engaged and the duration of engagement in each activity. Game-based group activities such as these are not typically used in intervention sessions for people with ABI who experience mild word-retrieval challenges. In fact, because of the subtlety of word retrieval difficulties experienced by people with relatively good recoveries from ABI--that is, the target population for this research--most people do not receive any treatment for this problem.
Phase III: Only people with ABI who have performed both Phase I and Phase II activities will be eligible for participation in Phase III. Following completion of the intervention sessions, participants will perform post-testing activities. Post-testing activities will include a subset of Phase I testing activities. Specifically, we will repeat (a) the audio recording of a conversational interaction and (b) the ERP recording with the same tasks used in Phase I.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's enrollment of 7 is below the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Nebraska Lincoln is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Phase 2 portion of the research during which participants with acquired brain injury will perform intervention activities.
Behavioral: Anomia treatment
Phase II participants will attend two-hour, group intervention sessions one day per week for eight weeks. Participants will engage in multiple word game activities throughout each intervention session. Games will include Facts in Five, Anomia, Boggle, and Bananagrams as well as variations on these, as appropriate.
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.
Time frame: The second day of participant enrollment and 10 weeks later on the last day of participant enrollment
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.
Time frame: First day of participant enrollment
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.
Time frame: First day of participant enrollment
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.
Time frame: First day of participant enrollment
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.
Time frame: First day of participant enrollment
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.
Time frame: The second day of participant enrollment and 10 weeks later on the last day of participant enrollment
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.
Time frame: First day of participant enrollment
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.
Time frame: Weeks two through nine of participant enrollment
Plan to share: No — The investigators do not plan to share IPD data because they do not believe the data can be adequately de-identified to protect the privacy of participants. This is because individuals with ABI constitute a relatively small number of people within the local community.
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Nov 2019, 24 months.
Of 284 non-industry interventional studies with no phase under Brain Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 24 months is close to that.
Counting every sponsor, half of 297 studies reached it within 24 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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University of Nebraska Lincoln