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Completed

NCT Number: NCT03230656

Cognitive-Communication Screening and Early Therapy for Adults With Mild TBI

Approximately 15-20% of patients diagnosed with a concussion/mild traumatic brain injury (mTBI) have persistent symptoms that continue up to six months or longer. Typical problems identified by these patients include difficulty with memory, multi-tasking, the ability to complete tasks quickly, and higher executive functions (e.g., inhibition, initiation, insight, motivation) (Belanger & Vanderploeg, 2005; Mott, McConnon, & Rieger, 2012, Rabinowitz & Levin, 2014). If these symptoms persist they can not only affect thinking, but also communication abilities (e.g., verbal and nonverbal interactions, reading, and writing) (ASHA, 2007). Therefore, it is hypothesized that screening measures that evaluate both thinking and communication can better identify individuals at-risk for persistent symptoms at two week and four weeks post-injury. Also, if cognitive-communication therapy was administered earlier post-injury, then outcomes related to return to daily activities, work, and/or the academic setting could possibly change. This study intends to investigate the use of cognitive and communication screening measures for the identification of persistent symptoms and the provision of early cognitive-communication therapy if problems persist.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Arizona University

Flagstaff, Arizona, 86011, United States

About this study

Approximately 15-20% of patients with concussion/mild traumatic brain injury (mTBI) have persistent cognitive symptoms up to six months or longer. Problems with working memory, divided attention, processing speed, and executive function are common (Belanger & Vanderploeg, 2005; Mott, McConnon, & Rieger, 2012, Rabinowitz & Levin, 2014). Patients often report how these problems negatively impact daily communication. Although neurocognitive tests are frequently used to identify patients at-risk for persistent symptoms, perhaps tests that not only assess cognition, but also communication would be better at identifying more functional deficits. Patients at-risk for persistent symptoms could then begin therapy earlier to address problems affecting work, school, or everyday activities. Speech-language pathologists are uniquely qualified to evaluate and treat patients with concussion/mTBI and cognitive-communication disorders (ASHA, 2005; Cicerone, et al.; Cornis-Pop et al., 2012). Cognitive-communication is the relationship between cognition and its influence on verbal and nonverbal communication, reading, and writing (ASHA, 2007). At this time, practice guidelines are emerging for cognitive-communication intervention related to concussion/mTBI (Cornis-Pop et al., 2012), yet there is still much research to be done. Typically, in recovery following a concussion/mTBI, patients are referred for cognitive-communication intervention if they are failing or struggling at work, school, or in daily activities. Some patients will not be seen for up to six months based on the assumption by healthcare professionals that most persistent cognitive and communication symptoms will resolve on their own. The wait period before referral for additional services is currently being investigated in the literature. Additionally, therapy for cognitive-communication will only be provided if patients report difficulties to their physicians and are referred for services. If services are not sought out, problems in cognitive-communication will go unrecognized as being a result of the concussion/mTBI.

The specific aims of this study are: 1) Determine if screening measures that evaluate symptoms of concussion/mTBI frequently used by speech-language pathologists administered two and four weeks post-injury will be able to predict individuals at-risk for persistent cognitive and communication symptoms, and 2) Will an early treatment group with persistent cognitive-communication deficits one month after injury differ in pre- and post-therapy functional outcome measure scores as compared to a delayed therapy group beginning services at two months post-injury?

Significance: Results of this study will increase the understanding in the use of cognitive and communication screening measures frequently administered by speech-language pathologists to identify patients at-risk for persistent symptoms related to concussion/mTBI and provide information about the outcomes of cognitive-communication intervention delivered early in recovery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed with concussion/mTBI by ER physician
  • speak English as the primary language
  • have functional hearing and vision to take the screening measures
  • have no prior history of a TBI requiring hospitalization and/or rehabilitation
  • have no history of other neurological or psychological diagnoses that would prevent the completion of the screening measures
  • mild to moderate hearing loss with aided amplification
  • reading glasses to correct their vision
  • bilingual subjects whose primary language is English will be included

Exclusion criteria

  • do not live in Flagstaff, AZ or the surrounding area making them unavailable for follow-up screening or therapy
  • English is not spoken as the primary language
  • have severe hearing loss or vision problems which cannot be corrected with hearing aids or glasses
  • prior history of a traumatic brain injury requiring hospitalization and/or rehabilitation
  • history of other neurological or psychological diagnoses preventing the completion of the screening sessions

Treatment and study plan

Early cognitive-communication therapy

Other

Other names: Early therapy 1 month post-injury, Waitlist therapy 2 months post-injury

Primary outcomes

  1. SCAN-A Competing Sentences Subtest

    Time frame: 20 minutes

    Assesses working memory, divided attention, and verbal language

  2. FAVRES Sequencing subtest

    Time frame: 20 minutes

    Evaluates executive function, verbal language, reading, and writing,

  3. WJ-III Tests of Cognitive Abilities Matching subtest

    Time frame: 3 minutes

    Evaluates speed of processing

  4. RBMT-3 Story Immediate and Delayed Recall

    Time frame: 15

    Assesses working memory and verbal language

Secondary outcomes

  1. Functional outcome measure

    Time frame: 40 minutes

    Same outcome measure will be used to determine functional abilities pre- and post-therapy

Sponsors and collaborators

Lead sponsor

Northern Arizona University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Cognitive-Communication Screening and Early Therapy for Adults With Concussion/Mild Traumatic Brain Injury

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2017
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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