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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of NSI in Differentiating Between Mild Traumatic Brain Injury And Behavioral Health Conditions

NCT01502839

Traumatic Brain Injury Post-Concussive Symptoms Post-Traumatic Stress Disorder

TERMINATED

PC-Based Cognitive Rehabilitation for Traumatic Brain Injury (TBI)

NCT00927576

Traumatic Brain Injury

COMPLETED

Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury

NCT04562844

Head Injury Trauma Cognition Disorder

UNKNOWN NA

Spotting and Managing Adult Repeated Traumas in the Brain

NCT07025317

Brain Injury Traumatic Mild

RECRUITING NA

Brain Stimulation and Cognitive Training

NCT03338673

Bipolar Disorder Schizo Affective Disorder Schizophrenia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Concussion Mild Traumatic Brain Injury Cognitive Communication Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Each participant diagnosed with concussion/mild traumatic brain injury will be screened for cognitive and communication abilities at two weeks post-injury and then four weeks post-injury. Standardized scores of the screening measures will identify subjects that are below one standard deviation below the mean. Subjects that continue to exhibit deficits after one month will be randomly placed into an early cognitive-communication therapy group (one month post-injury) or waitlist control group who receive therapy two month post-injury.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early therapy 1 month post-injury

Early cognitive-communication therapy 1 month post-injury:

* working memory strategies
* executive function program
* divided attention program
* environmental changes
* identification of problematic cognitive-communication situations

Group Type EXPERIMENTAL

Early cognitive-communication therapy

Intervention Type OTHER

Waitlist therapy 2 months post-injury

Waitlist early cognitive-communication therapy 2 months post injury:

\- Same cognitive-communication therapy is administered

Group Type ACTIVE_COMPARATOR

Early cognitive-communication therapy

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Early cognitive-communication therapy

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Early therapy 1 month post-injury Waitlist therapy 2 months post-injury

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No