Rehabilitation for Concussion

(STAR-C Trial)

Recruiting at 2 trial locations

Overseen By Chad E Grills, Ph.D

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must not be taking: Narcotic pain medications

Disqualifiers: Moderate/severe TBI, Schizophrenia, Neurological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 3-4 weeks

222 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using narcotic pain medications daily, you would not be eligible to participate.

What data supports the effectiveness of the treatment Symptom-Targeted Approach to Rehabilitation for Concussion?

Research on similar treatments, like cognitive rehabilitation and multimodal physical therapy, shows they can help improve symptoms in people with concussions. These therapies focus on specific symptoms and have been found safe and feasible, suggesting that a symptom-targeted approach could also be effective. ^{1 2 3 4 5}

Is the Symptom-Targeted Approach to Rehabilitation for Concussion generally safe for humans?

The safety of rehabilitation for concussion, including manual therapy techniques, is generally considered safe, but there is a need for better reporting and standardization of adverse events (unexpected, potentially harmful events). Some studies highlight the importance of including patient perspectives in defining adverse events to ensure a comprehensive understanding of safety. ^{6 7 8 9 10}

How is the Symptom-Targeted Approach to Rehabilitation for Concussion different from other treatments?

The Symptom-Targeted Approach to Rehabilitation for Concussion is unique because it focuses on identifying and treating specific symptoms caused by the concussion, such as dizziness and balance issues, through targeted therapies like vestibular rehabilitation and sub-symptom threshold aerobic exercise, rather than using a one-size-fits-all method. ^{11 12 13 14 15}

What is the purpose of this trial?

Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment. Hypothesis/Objectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.

Eligibility Criteria

This trial is for individuals with cognitive complaints after a mild traumatic brain injury (mTBI), who can read at a sixth-grade level or higher. It's not suitable for those with severe TBI, psychotic disorders, intensive psychiatric treatment, active suicidal thoughts, daily narcotic use, lack of telemedicine access, or other cognitive therapies.

Inclusion Criteria

A score of 2, 3, or 4 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints

A score on the Word Reading Subtest of the Wide Range Achievement Test of a sixth-grade reading level or higher, to ensure participants can read study materials

I have had a mild traumatic brain injury more than 3 months ago.

Exclusion Criteria

Lifetime diagnosis of schizophrenia or other psychotic/thought disorder

History of a moderate, severe, or penetrating TBI as defined by DoD/VA guidelines

Current participation in intensive behavioral health treatment for any psychiatric or substance use disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive STAR-C cognitive rehabilitation treatment, either in-person or via telehealth, for up to nine sessions plus one wrap-up session. The treatment includes compensatory strategies and weekly homework assignments.

3-4 weeks

Up to 10 sessions (in-person or virtual)

Waitlist Control

Participants in the control group do not receive treatment for 4 weeks and are asked to remain stable on existing treatments.

4 weeks

1 visit (in-person or virtual)

Follow-up

Participants are monitored for maintenance of treatment effects at 1-month and 3-month follow-ups.

3 months

2 visits (in-person or virtual)

Treatment Details

Interventions

• Symptom-Targeted Approach to Rehabilitation for Concussion

Trial Overview The STAR-C program aims to reduce cognitive issues in mTBI patients and will be tested through three methods: in-person sessions, telehealth (remote) sessions, and a no-treatment control group. The effectiveness will be evaluated immediately and up to three months post-treatment.

Participant Groups

Group I: Telehealth STAR-C Experimental Treatment 1 Intervention

Individuals assigned to this treatment will receive individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists via a telemedicine format. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help.

Group II: No Treatment Waitlist Experimental Treatment 1 Intervention

Individuals randomized to this arm will go for 4 weeks without treatment. During this time, participants will be asked to remain stable on treatments that they are already receiving for their concussive symptoms; that is and should not start a new treatment or change their medication. At the end of the 4-week wait, participant's will be asked about any changes to treatments that they have received during this time, and participants will be asked to complete questionnaires. This visit can be complete in person or remotely. Participants will be randomized into the in-person or telemedicine group.

Group III: In-Person STAR-C Experimental Treatment 1 Intervention

Individuals assigned to this treatment will receive in-person individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help.

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

Tripler Army Medical Center

Collaborator

Trials

23

Recruited

27,900+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

Findings from Research

In a 6-week randomized control trial involving 126 service members with a history of concussions, cognitive rehabilitation interventions led to significant improvements in cognitive, psychological, and neurobehavioral functioning for all participants.

The number of concussions experienced by participants did not influence the degree of improvement in symptoms, indicating that cognitive rehabilitation can be effective regardless of concussion history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Number of Concussions Does Not Affect Treatment Response to Cognitive Rehabilitation Interventions Following Mild TBI in Military Service Members. Ord, AS., Shura, RD., Curtiss, G., et al.[2021]

A study involving 25 patients aged 12-20 with post-concussion syndrome showed that a multimodal physical therapy approach significantly reduced symptoms, as indicated by a decrease in the Post-Concussion Symptom Scale scores from an average of 18.2 to 9.1 after treatment.

The therapy also improved physical performance, with a 23% increase in maximum symptom-free heart rate during exercise and a 52% reduction in balance errors, demonstrating both safety and efficacy in managing post-concussion symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal impairment-based physical therapy for the treatment of patients with post-concussion syndrome: A retrospective analysis on safety and feasibility. Grabowski, P., Wilson, J., Walker, A., et al.[2022]

In a study of 193 pediatric patients with severe traumatic brain injury (sTBI), 53% experienced at least one adverse event (AE), highlighting the high risk of complications in this vulnerable population.

The most common AE was decubitus ulcers, and patients with AEs had longer hospital stays and higher costs, indicating that identifying and preventing AEs can improve patient safety and reduce healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. Charyk Stewart, T., Luong, K., Alharfi, I., et al.[2021]

Patients define adverse events (AEs) from manual therapy (MT) based on pain severity, functional impact, duration, and the exclusion of other causes, highlighting a more nuanced understanding of AEs than previously recognized.

The study emphasizes the importance of incorporating patient perspectives in defining AEs in MT practices, suggesting that current frameworks may overlook critical aspects of patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Carlesso, LC., Cairney, J., Dolovich, L., et al.[2022]

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.

Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. Rogers, AS.[2022]

Orthopaedic physical therapy is generally considered safe, but there is a lack of high-quality data documenting its safety, particularly regarding cervical manipulation, highlighting the need for more rigorous research on potential harms.

Current research shows poor reporting standards for adverse events in orthopaedic physical therapy, indicating a need for standardized terminology and better documentation practices to ensure informed consent and clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. Carlesso, LC., Macdermid, JC., Santaguida, LP.[2022]

References

1. Hungary pubmed.ncbi.nlm.nih.gov

[Rehabilitation results after severe traumatic brain injury]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Protocol for the mixed-methods development of a concussion-specific health-related quality of life outcome measure based on the international classification of functioning, disability and health. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Proposal of a Functional Impairment Symptom Scale for Concussion. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Number of Concussions Does Not Affect Treatment Response to Cognitive Rehabilitation Interventions Following Mild TBI in Military Service Members. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Multimodal impairment-based physical therapy for the treatment of patients with post-concussion syndrome: A retrospective analysis on safety and feasibility. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Assessing Adverse Events After Chiropractic Care at a Chiropractic Teaching Clinic: An Active-Surveillance Pilot Study. [2021]

8. Scotland pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events: identification and attribution. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. [2022]

11. Sweden pubmed.ncbi.nlm.nih.gov

Occupational and Physiotherapy modalities used to support interdisciplinary rehabilitation after concussion: A Scoping Review. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Vestibular rehabilitation for dizziness and balance disorders after concussion. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of Sport-Related Concussion. [2020]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Rehabilitation after traumatic brain injury. [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Current and emerging rehabilitation for concussion: a review of the evidence. [2018]