Targeted Treatments for Concussion

Overseen By Anthony Kontos, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Stroke, Dementia, Epilepsy, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to conduct the first randomized control trial for targeted treatments for concussion in adults 50 years or older. Participants will be enrolled at their first concussion clinical visit (V1) and their second study visit will occur after (up to 7 days) or concurrently with the participant's second concussion clinical visit, typically (but not limited to) between 21-31 days from V1.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Behavioral Control, Targeted Intervention for concussion?

Research suggests that using psychoeducation (teaching about the condition) and cognitive strategy instruction (teaching ways to improve thinking skills) can help manage symptoms like attention and memory problems after a concussion. This approach is personalized and adapts to the individual's needs, which may support its effectiveness. ^{1 2 3 4 5}

How does the Behavioral Control, Targeted Intervention treatment for concussion differ from other treatments?

This treatment is unique because it uses a personalized, dynamic approach tailored to each individual's symptoms, focusing on psychoeducation and cognitive strategy instruction to address cognitive impairments like attention and memory issues. It also involves tracking progress and adapting strategies based on the client's performance, which is not commonly emphasized in other treatments. ^{1 6 7 8 9}

Research Team

Anthony Kontos, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults aged 50 or older who have been diagnosed with a concussion within the last 4 days to 12 months. They must be able to read and write for assessments and are recruited at their initial concussion appointment. Those with neurological disorders, major psychiatric conditions other than depression/anxiety, or severe brain injuries/surgery are excluded.

Inclusion Criteria

I am 50 years old or older.

Must be recruited at their initial concussion appointment

Ability to read/write to complete study assessments/testing

Exclusion Criteria

Diagnosed major psychiatric disorders other than depression/anxiety (e.g., schizophrenia)

I have been diagnosed with a neurological disorder like stroke, dementia, or epilepsy.

I have had a moderate to severe brain injury or brain surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive targeted treatments for concussion, including cognitive screening and symptom questionnaires

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of symptom severity and cognitive function

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Behavioral Control
• Targeted Intervention

Trial Overview The study is testing targeted treatments for concussions in older adults through a randomized control trial. Participants will receive either behavioral control measures or specific interventions aimed at treating concussion symptoms, assessed during two clinic visits.

Participant Groups

Group I: Targeted Intervention Experimental Treatment 1 Intervention

Participant receives exercises or strategies based on their clinical concussion domain given to them by their neuropsychologist: 1) Anxiety/Mood, 2)Headache/Migraine, 3)Vestibular, 4)Ocular, 5)Cognitive.

Group II: Behavioral Control Active Control 1 Intervention

Participants randomized to the behavioral control group will receive standardized (i.e., all participants in this group will receive the same interventions) behavioral management strategies that include activity, hydration, nutrition, sleep, and stress management strategies.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Findings from Research

Psychoeducation and cognitive strategy instruction are effective treatment components for addressing prolonged concussion symptoms (PCS), particularly for cognitive impairments in attention, working memory, and executive functioning.

A personalized, dynamic approach to managing PCS, which includes individualized tracking of progress and treatment adaptation based on client performance, shows promise in effectively targeting functional goals disrupted by concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. Wright, J., Sohlberg, MM.[2021]

In a review of 24 cases of students with persistent cognitive symptoms after sport-related concussions, 83% achieved their self-selected functional goals through individualized interventions by speech-language pathologists.

The treatments included direct attention training, metacognitive strategy training, assistive technology training, and psychoeducational supports, highlighting a range of effective strategies for managing post-concussion cognitive issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Persistent Cognitive Symptoms After Sport-Related Concussion. Sohlberg, MM., Ledbetter, AK.[2018]

A pilot study involving 21 family physicians showed that training on new return-to-activity guidelines after concussion significantly increased physicians' knowledge (from 6.3 to 8.8 correct answers out of 10) and adherence to the guidelines (from 25% to 86%).

Despite the positive changes in knowledge and adherence, the study faced challenges in recruitment and retention, indicating that improvements are needed for a larger trial to effectively implement these guidelines in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. Silverberg, ND., Otamendi, T., Panenka, WJ., et al.[2023]

A review of 71 interventional clinical trials on concussion treatment revealed a variety of approaches being tested, including cognitive therapies and medications, but highlighted a lack of evidence supporting specific return-to-activity protocols.

The median enrollment for these trials was only 60 participants, indicating that small sample sizes and differences in trial designs could limit the reliability of findings and their application in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In search of evidence-based treatment for concussion: characteristics of current clinical trials. Burke, MJ., Fralick, M., Nejatbakhsh, N., 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 systematic review of seven studies involving 118 subjects found that methylphenidate (MPH) can have some positive effects on hyperactivity and impulsivity in individuals with ADHD secondary to traumatic brain injury (TBI), but these effects are not as strong as those seen in primary ADHD cases.

The evidence for MPH's efficacy is modest, and more favorable outcomes were noted when treatment was started soon after the head injury, highlighting the need for further rigorous research to better understand its effectiveness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methylphenidate treatment of attention-deficit/hyperactivity disorder secondary to traumatic brain injury: a critical appraisal of treatment studies. Jin, C., Schachar, R.[2019]

Education about head injury effects and reassurance about symptom recovery were the most frequently reported effective interventions for post-concussion syndrome, highlighting the importance of patient support during recovery.

Other useful treatments included graded resumption of activity, antidepressant medication, and cognitive restructuring, indicating a multifaceted approach to managing post-concussion symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of treatments for post-concussion syndrome. Mittenberg, W., Burton, DB.[2019]

A chart review of 10 children with traumatic brain injury (TBI) showed that methylphenidate (MPH) effectively improved cognitive function, behavior, and arousal, indicating its potential as a treatment for post-TBI issues.

MPH was particularly beneficial for eight children experiencing cognitive and behavioral problems and two minimally responsive patients, suggesting it may help address similar challenges seen in ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of methylphenidate in paediatric traumatic brain injury. Hornyak, JE., Nelson, VS., Hurvitz, EA.[2019]

A randomized controlled trial involving 73 adults with persistent postconcussion symptoms showed that graded exposure therapy (GET) significantly reduced fear avoidance behavior compared to operant condition-based pacing strategies plus mindfulness training (Pacing+).

The study demonstrated strong feasibility for future trials, with high treatment adherence (89% completion rate) and excellent treatment fidelity (96.8% of essential elements covered), indicating that GET could be an effective intervention to help prevent disability after concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. Silverberg, ND., Cairncross, M., Brasher, PMA., et al.[2022]

References

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

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. [2021]

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

Management of Persistent Cognitive Symptoms After Sport-Related Concussion. [2018]

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

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

In search of evidence-based treatment for concussion: characteristics of current clinical trials. [2022]

5. 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]

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

Methylphenidate treatment of attention-deficit/hyperactivity disorder secondary to traumatic brain injury: a critical appraisal of treatment studies. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A survey of treatments for post-concussion syndrome. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The use of methylphenidate in paediatric traumatic brain injury. [2019]

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

Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. [2022]