Language Assessment and Treatment Following Acquired Brain Injury

NCT03320954 | Completed

• 1 other identifier: 17512
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brain Injuries

Keywords

Language; Anomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Total raw score on Test of Adolescent/Adult Word Retrieval

  First day of participant enrollment

• Executive Functions Domain score on the Cognitive Linguistic Quick Test

  First day of participant enrollment

• Visuospatial Domain score on the Cognitive Linguistic Quick Test

  First day of participant enrollment

• Trials 1-5 Free Recall Total Correct on the California Verbal Learning Test - II

  First day of participant enrollment

• Change in number of self-reported instances of word retrieval difficulty

  The second day of participant enrollment and 10 weeks later on the last day of participant enrollment

Other Outcomes (1)

• Time spent performing specific intervention activities

  Weeks two through nine of participant enrollment

Study Arms (1)

Anomia treatment

EXPERIMENTAL

Phase 2 portion of the research during which participants with acquired brain injury will perform intervention activities.

Behavioral: Anomia treatment

Interventions

Anomia treatment BEHAVIORAL

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.

Anomia treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Do not speak English as a primary language

Sponsors & Collaborators

• University of Nebraska Lincoln: lead

Study Sites (1)

University of Nebraska Lincoln

Lincoln, Nebraska, 68588, United States

Location

MeSH Terms

Conditions

Brain Injuries; Language; Anomia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Communication; Behavior; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen A Hux, PhD

  University of Nebraska Lincoln

  PRINCIPAL INVESTIGATOR

• Kathy Chiou, PhD

  University of Nebraska Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 25, 2017
• Study Start: October 25, 2017
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)