ConcussionNCT03230656
Cognitive-Communication Screening and Early Therapy for Adults With Mild TBI
A study testing Early cognitive-communication therapy in people with Concussion and Mild Traumatic Brain Injury, run by Northern Arizona University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Concussion, Mild Traumatic Brain Injury, Cognitive Communication Disorder
- What is being tested?
- Early cognitive-communication therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Arizona University
Flagstaff, Arizona, 86011
About this study
Official title: Cognitive-Communication Screening and Early Therapy for Adults With Concussion/Mild Traumatic Brain Injury
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.
Read the 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.
- Being tested
- Early cognitive-communication therapy
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early cognitive-communication therapyOther
Also called Early therapy 1 month post-injury, Waitlist therapy 2 months post-injury
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Early cognitive-communication therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCAN-A Competing Sentences Subtest
Assesses working memory, divided attention, and verbal language
Measured: 20 minutes
FAVRES Sequencing subtest
Evaluates executive function, verbal language, reading, and writing,
Measured: 20 minutes
WJ-III Tests of Cognitive Abilities Matching subtest
Evaluates speed of processing
Measured: 3 minutes
RBMT-3 Story Immediate and Delayed Recall
Assesses working memory and verbal language
Measured: 15
Secondary outcomes (1)
Functional outcome measure
Same outcome measure will be used to determine functional abilities pre- and post-therapy
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study startJan 2017
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Emi Isaki, Northern Arizona University
- Investigators
- Emi Isaki, Ph.D., Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230656
- Sponsor's protocol ID
- 1003140
- Other IDs
- 1R15DC015338-01A1
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2017
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 16209414Mott TF, McConnon ML, Rieger BP. Subacute to chronic mild traumatic brain injury. Am Fam Physician. 2012 Dec 1;86(11):1045-51.
PubMed 23198672Rabinowitz 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.
PubMed 24529420Cicerone 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.
PubMed 21440699Cornis-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.
PubMed 23341288
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Communication Screening and Early Therapy for Adults With Concussion/Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03230656
- Acronym / sponsor ID
- 1003140
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early therapy 1 month post-injury | Experimental | Other: Early cognitive-communication therapyEarly 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 therapy 2 months post-injury | Active comparator | Other: Early cognitive-communication therapyWaitlist early cognitive-communication therapy 2 months post injury: - Same cognitive-communication therapy is administered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early cognitive-communication therapyAlso: Early therapy 1 month post-injury, Waitlist therapy 2 months post-injury | Other | Early therapy 1 month post-injury, Waitlist therapy 2 months post-injury |
Primary outcome
SCAN-A Competing Sentences Subtest
Time frame: 20 minutes
Assesses working memory, divided attention, and verbal language
FAVRES Sequencing subtest
Time frame: 20 minutes
Evaluates executive function, verbal language, reading, and writing,
WJ-III Tests of Cognitive Abilities Matching subtest
Time frame: 3 minutes
Evaluates speed of processing
RBMT-3 Story Immediate and Delayed Recall
Time frame: 15
Assesses working memory and verbal language
1 secondary outcome
Functional outcome measure
Time frame: 40 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Background: PubMed 16209414Belanger 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.
- Background: PubMed 23198672Mott TF, McConnon ML, Rieger BP. Subacute to chronic mild traumatic brain injury. Am Fam Physician. 2012 Dec 1;86(11):1045-51.
- Background: PubMed 24529420Rabinowitz 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.
- Background: PubMed 21440699Cicerone 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.
- Background: PubMed 23341288Cornis-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.
- Roles of speech-language pathologists in the identification, diagnosis, and treatment of individuals with cognitive-communication disorders \[Position Statement\]Link provided by the sponsor.
- Scope of practice in speech-language pathology \[Scope of Practice\]Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emi Isaki, Ph.D. principal investigator
Northern Arizona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early cognitive-communication therapy in people with Concussion and Mild Traumatic Brain Injury, run by Northern Arizona University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCAN-A Competing Sentences Subtest (time frame: 20 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03230656, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.