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Targeted Treatments for Concussion
N/A
Recruiting
Led By Anthony Kontos, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion, an average of 30 days after visit 1
Awards & highlights
Study Summary
This trial tests targeted treatments for people 50+ with concussion, enrolling them at their first clinical visit and studying them up to 31 days later.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves behavioral controls and targeted interventions rather than medication, side effects may include discomfort from therapy sessions or emotional distress but should not involve physical drug-related side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at study completion, an average of 30 days after visit 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion, an average of 30 days after visit 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concussion Clinical Profiles Screening (CP Screen)
Secondary outcome measures
Dizziness Handicap Inventory (DHI)
General Anxiety Disorder-7 (GAD-7)
Headache Impact Test-6 (HIT-6)
+13 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Targeted InterventionExperimental Treatment1 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 ControlActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Targeted Intervention
2015
N/A
~1440
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,723 Previous Clinical Trials
16,343,106 Total Patients Enrolled
Anthony Kontos, PhDPrincipal InvestigatorUniversity of Pittsburgh
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 50 years old or older.I have been diagnosed with a neurological disorder like stroke, dementia, or epilepsy.I was diagnosed with a concussion between 4 days and 12 months ago.I have had a moderate to severe brain injury or brain surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Behavioral Control
- Group 2: Targeted Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants of this experiment who are older than two decades being considered?
"This particular trial seeks participants aged 50 to 99. However, there are 28 clinical trials for younger people and 44 medical studies targeting senior citizens."
Answered by AI
Who meets the criteria to participate in this clinical research?
"This clinical trial is seeking individuals aged 50 to 99 years old who have suffered a traumatic brain injury. Approximately fifty volunteers are necessary for the research to be successful."
Answered by AI
Could you provide information about current eligibility for this research project?
"The clinicaltrials.gov database confirms that this trial, which had its inception date on June 1st 2023 and last update on May 4th 2023 is not presently seeking participants. However, there are still 83 other trials in need of candidates at the moment."
Answered by AI
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