Brain InjuriesNCT03320954
Language Assessment and Treatment Following Acquired Brain Injury
A study testing Anomia treatment in people with Brain Injuries, run by University of Nebraska Lincoln at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Anomia treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2017to 14 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Do not speak English as a primary language
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Lincoln
Lincoln, Nebraska, 68588
About this study
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.
Read the detailed description
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:
- word retrieval: The participant will view a series of neutral stimuli (i.e., pictures of familiar objects, people, or locations flashed briefly on a computer monitor). The participant will press one of three buttons to indicate (a) recall of the name of the depicted image, (b) knowledge of the name but inability to recall it, or (c) no knowledge of the name of the depicted image. If a participant does not press a button within the time limit of the stimulus presentation, a new stimulus trial will begin. During some trials, participants will perform a second task requiring judgment about the orientation of lines appearing after the stimulus image. Following completion of all trials, the investigators will present the stimulus images a second time along with three response options: (a) the correct name, (b) an incorrect name, and (c) "don't know." The participant will again use a button press to indicate his/her response choice.
- stimulus categorization: The participant will view a series of objects. For each object, he/she will categorize the stimulus semantically (e.g., Is the object a fruit or animal?) or phonologically (e.g., Does the object start with the letter "L" or "N?"). Participants will respond by pushing a button.
- deductive reasoning: The participant will view written word pairs. Some of the pairs will relate to a specific word (e.g., "desert" and "humps" relate to "camel"), whereas other pairs will not (e.g., "desert" and "bark"). The participant will press one of two buttons to indicate whether a word pair triggers or does not trigger recall of a related word.
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.
- Conditions
- Brain Injuries
- Being tested
- Anomia treatment
- Keywords
- Language, Anomia
- Medical subject headings
- Brain Injuries, Language, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anomia treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Anomia treatment | Experimental | Phase 2 portion of the research during which participants with acquired brain injury will perform intervention activities. Receives: Behavioral: Anomia treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The second day of participant enrollment and 10 weeks later on the last day of participant enrollment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First day of participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start25 Oct 2017
- Primary completion14 Nov 2019
- Study completion14 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1 participants will include people with and without acquired brain injuries. This phase does not involve any intervention. Phase 2 participants will include only people with acquired brain injuries. This portion of the research involves an intervention procedure. All participants will receive the same intervention. Phase 3 participants will be limited to those people with acquired brain injuries who completed Phases 1 and 2. Phase 3 does not involved any intervention.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen A Hux, PhD, Principal investigator, University of Nebraska LincolnKathy Chiou, PhD, Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320954
- Sponsor's protocol ID
- 17512
- Status last verified
- Nov 2019
- First submitted
- 9 Oct 2017
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Language Assessment and Treatment Following Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03320954
- Acronym / sponsor ID
- 17512
- Conditions
- Brain Injuries
- Keywords
- Language, Anomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- 14 Nov 2019 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- word retrieval: The participant will view a series of neutral stimuli (i.e., pictures of familiar objects, people, or locations flashed briefly on a computer monitor). The participant will press one of three buttons to indicate (a) recall of the name of the depicted image, (b) knowledge of the name but inability to recall it, or (c) no knowledge of the name of the depicted image. If a participant does not press a button within the time limit of the stimulus presentation, a new stimulus trial will begin. During some trials, participants will perform a second task requiring judgment about the orientation of lines appearing after the stimulus image. Following completion of all trials, the investigators will present the stimulus images a second time along with three response options: (a) the correct name, (b) an incorrect name, and (c) "don't know." The participant will again use a button press to indicate his/her response choice.
- stimulus categorization: The participant will view a series of objects. For each object, he/she will categorize the stimulus semantically (e.g., Is the object a fruit or animal?) or phonologically (e.g., Does the object start with the letter "L" or "N?"). Participants will respond by pushing a button.
- deductive reasoning: The participant will view written word pairs. Some of the pairs will relate to a specific word (e.g., "desert" and "humps" relate to "camel"), whereas other pairs will not (e.g., "desert" and "bark"). The participant will press one of two buttons to indicate whether a word pair triggers or does not trigger recall of a related word.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1 participants will include people with and without acquired brain injuries. This phase does not involve any intervention. Phase 2 participants will include only people with acquired brain injuries. This portion of the research involves an intervention procedure. All participants will receive the same intervention. Phase 3 participants will be limited to those people with acquired brain injuries who completed Phases 1 and 2. Phase 3 does not involved any intervention.
| Arm | Type | Receives |
|---|---|---|
| Anomia treatment | Experimental | Behavioral: Anomia treatmentPhase 2 portion of the research during which participants with acquired brain injury will perform intervention activities. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Do not speak English as a primary language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anomia treatmentPhase 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. | Behavioural | Anomia treatment |
Primary outcome
Change in amplitude of N400 event related potential (ERP) as measured in microvolts.
Time frame: The second day of participant enrollment and 10 weeks later on the last day of participant enrollment
ERP recordings will be taken while a participant performs naming tasks. The average amplitude of N400 will be measured in microvolts across trials.
6 secondary outcomes
Total raw score on Test of Adolescent/Adult Word Retrieval
Time frame: First day of participant enrollment
Executive Functions Domain score on the Cognitive Linguistic Quick Test
Time frame: First day of participant enrollment
Visuospatial Domain score on the Cognitive Linguistic Quick Test
Time frame: First day of participant enrollment
Trials 1-5 Free Recall Total Correct on the California Verbal Learning Test - II
Time frame: First day of participant enrollment
Change in number of self-reported instances of word retrieval difficulty
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.
Time frame: First day of participant enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen A Hux, PhD principal investigator
University of Nebraska Lincoln
Kathy Chiou, PhD principal investigator
University of Nebraska Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anomia treatment in people with Brain Injuries, run by University of Nebraska Lincoln at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in amplitude of N400 event related potential (ERP) as measured in microvolts. (time frame: The second day of participant enrollment and 10 weeks later on the last day of participant enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.