50 Participants Needed

Targeted Treatments for Concussion

AK
Overseen ByAnthony Kontos, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test new treatments for concussions in adults aged 50 and older. It compares two approaches: one group follows set guidelines on lifestyle habits like activity and sleep (Behavioral Control), while the other receives personalized exercises from a neuropsychologist based on specific concussion symptoms, such as headaches or dizziness (Targeted Intervention). Eligible participants must have had a concussion diagnosed within the past year and be attending their first concussion doctor visit. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve concussion recovery strategies.

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.

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

Research has shown that starting treatment early for concussions is generally safe. Evidence suggests that beginning physical therapy soon after a concussion can speed up recovery and improve well-being.

Additionally, studies indicate that exercises and strategies tailored to specific symptoms, such as anxiety, headaches, or balance issues, can be beneficial. These targeted treatments have been tested in groups like young athletes and veterans, showing promising results without major safety concerns.

Overall, these treatments are usually well-tolerated, with few reported side effects. The goal is to enhance recovery by focusing on specific symptoms, making the approach both personalized and safe.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for concussion because they take a personalized and holistic approach. Unlike traditional methods that often focus on rest and gradual return to activity, the Targeted Intervention offers exercises and strategies tailored to specific concussion symptoms like anxiety, headaches, or cognitive issues. This individualized care aims to address the diverse ways concussions can affect people, potentially leading to more effective and quicker recovery. Meanwhile, the Behavioral Control group emphasizes essential lifestyle changes—like hydration, nutrition, and stress management—that support the body's natural healing processes. Together, these approaches highlight a shift towards more comprehensive and adaptable concussion care.

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

Research has shown that specific treatments can improve mental health and well-being after a concussion. In this trial, participants in the Targeted Intervention arm will receive exercises or strategies tailored to their clinical concussion domain, such as anxiety, mood, headaches, migraines, balance, eye problems, or thinking difficulties. Activities like brain exercises and mental training have proven especially helpful for addressing mental challenges post-concussion. While the results are promising, researchers are still learning about the effectiveness of these psychological treatments for long-term symptoms. Overall, these targeted treatments appear to have potential for aiding adult recovery from a concussion.678910

Who Is on the Research Team?

AK

Anthony Kontos, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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

Ability to read/write to complete study assessments/testing
Must be recruited at their initial concussion appointment
I am 50 years old or older.
See 1 more

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Targeted InterventionExperimental Treatment1 Intervention
Group II: Behavioral ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Published Research Related to This Trial

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.
The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms.Wright, J., Sohlberg, MM.[2021]
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.
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 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.
The use of methylphenidate in paediatric traumatic brain injury.Hornyak, JE., Nelson, VS., Hurvitz, EA.[2019]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37256279/
Effectiveness of interventions for the improvement ...Cognitive rehabilitation and neurocognitive training may be the most effective interventions for mental health and well-being impairments post-concussion.
Targeted multidomain intervention for complex mTBIThis multisite randomized controlled trial (RCT) will determine the effectiveness of a targeted multidomain (T-MD) intervention (anxiety/mood, cognitive, ...
Patient-centered mild traumatic brain injury interventions in ...The diverse study protocols, sample compositions, and outcome measures included in this review also limits our ability to analyze intervention effectiveness.
Full article: What psychological interventions are effective ...There remains limited insight into the effectiveness of psychological interventions for the treatment of prolonged post-concussion symptoms (PrPCS).
Management of Concussion and Mild Traumatic Brain InjuryThe article offers guidance on key clinical decisions in mTBI care and highlights priority interventions that can be initiated in primary care to prevent ...
What are the evidence-based medical management ...Five studies reported on novel treatment interventions for concussed youth athletes (36,44,50-52). Of those, two studies aimed to establish the ...
Symptom-Targeted Rehabilitation for ConcussionThe investigators are comparing two methods for helping improve everyday cognitive functioning in Canadian Armed Forces (CAF) veterans who have sustained a ...
Early intervention treatment in the first 2 weeks following ...Two studies reported significant improvement in selected concussion symptoms following manual therapy (at 48–72 hours post-treatment) or telephone counselling ...
Physical Therapy Evaluation and Treatment After ...Evidence indicates that physical therapy early after concussion is safe, and that earlier initiation of physical therapy interventions may facilitate a faster ...
Pediatric Sport-Related Concussion: Recommendations ...Prescribed aerobic exercise treatment within 14 days of SRC also significantly reduced the incidence of concussive symptoms persisting beyond 30 ...
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