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?

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.

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.12345

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.16789

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

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

Citations

The Implementation of a Personalized Dynamic Approach for the Management of Prolonged Concussion Symptoms. [2021]
Management of Persistent Cognitive Symptoms After Sport-Related Concussion. [2018]
De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. [2023]
In search of evidence-based treatment for concussion: characteristics of current clinical trials. [2022]
Number of Concussions Does Not Affect Treatment Response to Cognitive Rehabilitation Interventions Following Mild TBI in Military Service Members. [2021]
Methylphenidate treatment of attention-deficit/hyperactivity disorder secondary to traumatic brain injury: a critical appraisal of treatment studies. [2019]
A survey of treatments for post-concussion syndrome. [2019]
The use of methylphenidate in paediatric traumatic brain injury. [2019]
Feasibility of Concussion Rehabilitation Approaches Tailored to Psychological Coping Styles: A Randomized Controlled Trial. [2022]
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