Rehabilitation for Concussion

(STAR-C Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a rehabilitation method called STAR-C (Symptom-Targeted Approach to Rehabilitation for Concussion) to reduce everyday cognitive issues in individuals with mild traumatic brain injury (mTBI). Participants are divided into three groups: one receives in-person treatment, another receives treatment via telehealth, and the third serves as a control with no initial treatment. The trial aims to determine if the STAR-C approach effectively alleviates cognitive complaints and how it can be implemented in various clinical settings. This trial suits those who experienced an mTBI over three months ago and continue to face cognitive problems. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance rehabilitation methods for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that the Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C) is generally well-tolerated. Research indicates that both the in-person and telehealth versions of STAR-C help improve memory and attention skills. This method employs strategies to manage symptoms effectively.

Significant reports of unwanted side effects have not emerged. The treatment involves working with trained therapists in sessions designed to be safe and beneficial. As these are early studies, the primary goal has been to assess the approach's practicality and tolerability.

Overall, evidence suggests that STAR-C is safe for individuals with mild traumatic brain injury (mTBI), such as concussions. The treatment aims to provide a supportive, strategic way to help those recovering from concussions improve their daily cognitive challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C) because it offers a personalized and flexible approach to concussion recovery. Unlike standard treatments that often rely on rest and gradual return to activities, STAR-C focuses on cognitive rehabilitation tailored to individual needs. The treatment is available both in-person and via telehealth, providing convenient access for participants. This method emphasizes compensatory strategies and includes homework assignments to reinforce learning, aiming to empower patients to maintain their progress independently.

What evidence suggests that this trial's treatments could be effective for concussion rehabilitation?

This trial will compare different approaches to the Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C). Studies have shown that STAR-C, whether conducted in-person or via telehealth, can reduce memory and thinking problems in people with mild traumatic brain injury (mTBI). Research indicates that exercises to enhance thinking skills can aid in everyday tasks. Specifically, learning strategies to manage these issues has proven effective in reducing daily challenges. For telehealth, additional studies suggest that remote care can match the effectiveness of in-person treatment, making access to care more convenient. Initial findings indicate that STAR-C can significantly benefit those with ongoing thinking problems after a concussion. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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Symptom-Targeted Approach to Rehabilitation for ...

Hypothesis/Objectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a ...

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Symptom-Targeted Rehabilitation for Concussion

The investigators are comparing two methods for helping improve everyday cognitive functioning in Canadian Armed Forces (CAF) veterans who have sustained a ...

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Symptom-Targeted Approach to Rehabilitation for Concussion

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A strategy-based, brief, intensive cognitive rehabilitation intervention delivered to US service members and veterans with mild traumatic brain injury.

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sciencedirect.com/science/article/pii/S1877065723000489

Interdisciplinary rehabilitation for persisting post- ...

This pilot study aimed to explore the feasibility and preliminary efficacy of an interdisciplinary intervention for PPCSs.