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

NCT03230656 | Completed

• 2 other identifiers: 10031401R15DC015338-01A1
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion; Mild Traumatic Brain Injury; Cognitive Communication Disorder

Outcome Measures

Primary Outcomes (4)

• SCAN-A Competing Sentences Subtest

  Assesses working memory, divided attention, and verbal language

  20 minutes

• FAVRES Sequencing subtest

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

  20 minutes

• WJ-III Tests of Cognitive Abilities Matching subtest

  Evaluates speed of processing

  3 minutes

• RBMT-3 Story Immediate and Delayed Recall

  Assesses working memory and verbal language

  15

Secondary Outcomes (1)

• Functional outcome measure

  40 minutes

Study Arms (2)

Early therapy 1 month post-injury

EXPERIMENTAL

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

Other: Early cognitive-communication therapy

Waitlist therapy 2 months post-injury

ACTIVE COMPARATOR

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

Other: Early cognitive-communication therapy

Interventions

Early cognitive-communication therapy OTHER

Also known as: Early therapy 1 month post-injury, Waitlist therapy 2 months post-injury

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Arizona University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

Related Publications (5)

• 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.

  PMID: 16209414 BACKGROUND

• Mott TF, McConnon ML, Rieger BP. Subacute to chronic mild traumatic brain injury. Am Fam Physician. 2012 Dec 1;86(11):1045-51.

  PMID: 23198672 BACKGROUND

• 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.

  PMID: 24529420 BACKGROUND

• 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.

  PMID: 21440699 BACKGROUND

• 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.

  PMID: 23341288 BACKGROUND

Related Links

• Roles of speech-language pathologists in the identification, diagnosis, and treatment of individuals with cognitive-communication disorders \[Position Statement\]
• Scope of practice in speech-language pathology \[Scope of Practice\]

MeSH Terms

Conditions

Brain Concussion

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Emi Isaki, Ph.D.

  Northern Arizona University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 26, 2017
• Study Start: January 1, 2017
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)