search
Back to results

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

Primary Purpose

Concussion, Mild Traumatic Brain Injury, Cognitive Communication Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early cognitive-communication therapy
Sponsored by
Northern Arizona University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Concussion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northern Arizona University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early therapy 1 month post-injury

Waitlist therapy 2 months post-injury

Arm Description

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

Waitlist early cognitive-communication therapy 2 months post injury: - Same cognitive-communication therapy is administered

Outcomes

Primary Outcome Measures

SCAN-A Competing Sentences Subtest
Assesses working memory, divided attention, and verbal language
FAVRES Sequencing subtest
Evaluates executive function, verbal language, reading, and writing,
WJ-III Tests of Cognitive Abilities Matching subtest
Evaluates speed of processing
RBMT-3 Story Immediate and Delayed Recall
Assesses working memory and verbal language

Secondary Outcome Measures

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

Full Information

First Posted
July 25, 2017
Last Updated
August 16, 2021
Sponsor
Northern Arizona University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
search

1. Study Identification

Unique Protocol Identification Number
NCT03230656
Brief Title
Cognitive-Communication Screening and Early Therapy for Adults With Mild TBI
Official Title
Cognitive-Communication Screening and Early Therapy for Adults With Concussion/Mild Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Arizona University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild Traumatic Brain Injury, Cognitive Communication Disorder

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early therapy 1 month post-injury
Arm Type
Experimental
Arm Description
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
Arm Title
Waitlist therapy 2 months post-injury
Arm Type
Active Comparator
Arm Description
Waitlist early cognitive-communication therapy 2 months post injury: - Same cognitive-communication therapy is administered
Intervention Type
Other
Intervention Name(s)
Early cognitive-communication therapy
Other Intervention Name(s)
Early therapy 1 month post-injury, Waitlist therapy 2 months post-injury
Primary Outcome Measure Information:
Title
SCAN-A Competing Sentences Subtest
Description
Assesses working memory, divided attention, and verbal language
Time Frame
20 minutes
Title
FAVRES Sequencing subtest
Description
Evaluates executive function, verbal language, reading, and writing,
Time Frame
20 minutes
Title
WJ-III Tests of Cognitive Abilities Matching subtest
Description
Evaluates speed of processing
Time Frame
3 minutes
Title
RBMT-3 Story Immediate and Delayed Recall
Description
Assesses working memory and verbal language
Time Frame
15
Secondary Outcome Measure Information:
Title
Functional outcome measure
Description
Same outcome measure will be used to determine functional abilities pre- and post-therapy
Time Frame
40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emi Isaki, Ph.D.
Organizational Affiliation
Northern Arizona University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Arizona University
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to researchers outside of the current study. Results related to the study will be disseminated in future presentations and publications.
Citations:
PubMed Identifier
16209414
Citation
Belanger HG, Vanderploeg RD. The neuropsychological impact of sports-related concussion: a meta-analysis. J Int Neuropsychol Soc. 2005 Jul;11(4):345-57. doi: 10.1017/s1355617705050411.
Results Reference
background
PubMed Identifier
23198672
Citation
Mott TF, McConnon ML, Rieger BP. Subacute to chronic mild traumatic brain injury. Am Fam Physician. 2012 Dec 1;86(11):1045-51.
Results Reference
background
PubMed Identifier
24529420
Citation
Rabinowitz AR, Levin HS. Cognitive sequelae of traumatic brain injury. Psychiatr Clin North Am. 2014 Mar;37(1):1-11. doi: 10.1016/j.psc.2013.11.004. Epub 2014 Jan 14.
Results Reference
background
PubMed Identifier
21440699
Citation
Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.
Results Reference
background
PubMed Identifier
23341288
Citation
Cornis-Pop M, Mashima PA, Roth CR, MacLennan DL, Picon LM, Hammond CS, Goo-Yoshino S, Isaki E, Singson M, Frank EM. Guest editorial: Cognitive-communication rehabilitation for combat-related mild traumatic brain injury. J Rehabil Res Dev. 2012;49(7):xi-xxxii. doi: 10.1682/jrrd.2012.03.0048. No abstract available.
Results Reference
background
Links:
URL
http://www.asha.org/policy
Description
Roles of speech-language pathologists in the identification, diagnosis, and treatment of individuals with cognitive-communication disorders [Position Statement]
URL
http://www.asha.org/policy
Description
Scope of practice in speech-language pathology [Scope of Practice]

Learn more about this trial

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

We'll reach out to this number within 24 hrs