Symptom-Targeted Rehabilitation for Concussion

Mild Traumatic Brain Injury Clinical Trial

— STAR-C2  

Official title:

Symptom-Targeted Rehabilitation for Concussion in Canadian Armed Forces Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520710
• Other study ID #: 15032
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: December 2023
• Source: McMaster University
• Contact: Sarah Hagens
• Phone: 905-525-9140
• Email: hagens[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators are comparing two methods for helping improve everyday cognitive functioning in Canadian Armed Forces (CAF) veterans who have sustained a mild traumatic brain injury (mTBI). The two methods are 1) providing educational materials (Education Group) and 2) individual cognitive rehabilitation delivered by a trained Occupational Therapist or Speech-Language Pathologist (Therapy Group). The study is a pilot randomized controlled clinical trial (RCT), and will serve as pilot data for a future RCT.

Description:

The investigators are comparing two different methods for helping Canadian Armed Forces veterans with mild traumatic brain injury (mTBI) manage everyday cognitive difficulties. Cognitive rehabilitation is a type of therapy that helps people with brain injury who have challenges in everyday thinking. The investigators have developed a streamlined version of this type of cognitive rehabilitation therapy that can be done in person or virtually and takes place over a 3-week period. The investigators will provide education materials only to one group and individual cognitive rehabilitation delivered by a trained Speech Language Pathologist or Occupational Therapist to the other group. The investigators want to find out whether the individual therapy is better than providing the usual educational material. The therapy sessions are audio-recorded. At McMaster, the investigators job is to listen to the recordings and making sure the therapists are following the study manual. That includes making notes of what the therapists say or do. What the investigators learn in this study may help veterans with mTBI and cognitive issues affect their abilities to do everyday activities.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Is a community-dwelling Canadian Armed Forces veteran.
• Is age 18 years or older.
• Self-identifies as a fluent English speaker.
• Has no previous history of neurological disorder affecting cognition, by self-report.
• Is able to participate in rehabilitation for 4 weeks: 3 weeks of treatment + baseline + outcome assessment, with potential rescheduling for missed sessions.
• Is not actively participating in cognitive rehabilitation directed by a registered health professional (e.g., speech-language pathologist or occupational therapist).
• Has access to an electronic device with Zoom video platform capacity and internet access.

Exclusion Criteria:

• A score of less than 20 on the Montreal Cognitive Assessment (MoCA), which indicates a risk for dementia.
• Cannot identify at least 3 problems on the Common Cognitive Complaints after Concussion Questionnaire (C4), as there would be insufficient areas for intervention.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Behavioral:
• Cognitive Rehabilitation
A strategy-focused intervention aimed at improving everyday cognitive function, structured to maximize treatment dose over a short time period. The shorter time period of the treatment therapy is relative to the one and only current randomized controlled trial of cognitive rehabilitation for military mTBI, the Study of Cognitive Rehabilitation Effectiveness (SCORE).

Other:
• Education
Educational materials, designed to help people with traumatic brain injury manage their everyday cognitive challenges will be provided through Zoom video conferencing software.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Atlas Institute for Veterans and Families

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25. — View Citation

Cicerone KD, Goldin Y, Ganci K, Rosenbaum A, Wethe JV, Langenbahn DM, Malec JF, Bergquist TF, Kingsley K, Nagele D, Trexler L, Fraas M, Bogdanova Y, Harley JP. Evidence-Based Cognitive Rehabilitation: Systematic Review of the Literature From 2009 Through 2014. Arch Phys Med Rehabil. 2019 Aug;100(8):1515-1533. doi: 10.1016/j.apmr.2019.02.011. Epub 2019 Mar 26. — View Citation

Cooper DB, Bowles AO, Kennedy JE, Curtiss G, French LM, Tate DF, Vanderploeg RD. Cognitive Rehabilitation for Military Service Members With Mild Traumatic Brain Injury: A Randomized Clinical Trial. J Head Trauma Rehabil. 2017 May/Jun;32(3):E1-E15. doi: 10.1097/HTR.0000000000000254. — View Citation

Garber BG, Rusu C, Zamorski MA. Deployment-related mild traumatic brain injury, mental health problems, and post-concussive symptoms in Canadian Armed Forces personnel. BMC Psychiatry. 2014 Nov 20;14:325. doi: 10.1186/s12888-014-0325-5. — View Citation

Hoffman AN, Taylor AN. Stress reactivity after traumatic brain injury: implications for comorbid post-traumatic stress disorder. Behav Pharmacol. 2019 Apr;30(2 and 3-Spec Issue):115-121. doi: 10.1097/FBP.0000000000000461. — View Citation

Loignon A, Ouellet MC, Belleville G. A Systematic Review and Meta-analysis on PTSD Following TBI Among Military/Veteran and Civilian Populations. J Head Trauma Rehabil. 2020 Jan/Feb;35(1):E21-E35. doi: 10.1097/HTR.0000000000000514. — View Citation

Malec JF, Smigielski JS, DePompolo RW. Goal attainment scaling and outcome measurement in postacute brain injury rehabilitation. Arch Phys Med Rehabil. 1991 Feb;72(2):138-43. — View Citation

Management of Concussion/mTBI Working Group. VA/DoD Clinical Practice Guideline for Management of Concussion/Mild Traumatic Brain Injury. J Rehabil Res Dev. 2009;46(6):CP1-68. No abstract available. — View Citation

Marshall S, Bayley M, McCullagh S, Velikonja D, Berrigan L, Ouchterlony D, Weegar K; mTBI Expert Consensus Group. Updated clinical practice guidelines for concussion/mild traumatic brain injury and persistent symptoms. Brain Inj. 2015;29(6):688-700. doi: 10.3109/02699052.2015.1004755. Epub 2015 Apr 14. — View Citation

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

Soble JR, Silva MA, Vanderploeg RD, Curtiss G, Belanger HG, Donnell AJ, Scott SG. Normative Data for the Neurobehavioral Symptom Inventory (NSI) and post-concussion symptom profiles among TBI, PTSD, and nonclinical samples. Clin Neuropsychol. 2014;28(4):614-32. doi: 10.1080/13854046.2014.894576. Epub 2014 Mar 14. — View Citation

Tanev KS, Pentel KZ, Kredlow MA, Charney ME. PTSD and TBI co-morbidity: scope, clinical presentation and treatment options. Brain Inj. 2014;28(3):261-70. doi: 10.3109/02699052.2013.873821. — View Citation

Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	The primary outcome is the rate of recruitment, average 5 per month. The primary outcome is the rate of recruitment and retention rate reported as total number of participants recruited and retained.	12 months
Primary	Adherence to Intervention	Three quarters of participants should complete 80% of the prescribed intervention	12 months
Secondary	Acceptability of the Intervention	The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Acceptability of Intervention Measure (AIM).	Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.
Secondary	Acceptability of the Appropriateness	The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Intervention Appropriateness Measure (IAM).	Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.
Secondary	Acceptability of the Feasibility	The acceptability will be assessed by clinicians and participants. At least three quarters of participants and clinicians will provide a rating of 4 on the Feasibility of Intervention Measure (FIM).	Measures administered during intake (baseline), immediately after one of sessions 6-10 depending on targets achieved, and 1 month post-treatment.

External Links

•   The Canadian Occupational Performance Measure