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Targeted Multidomain Intervention for Concussion (T-MD Trial)

N/A

Recruiting

Led By Anthony P Kontod, 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

Participants must have reported or shown signs of mTBI including loss of consciousness, amnesia, disorientation/confusion, dizziness, imbalance, memory problems, vomiting

Participants must have been diagnosed with complex mTBI in the past 8 days-6 months with clear mechanism of injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the bsi-18 will be measured from baseline to 3 months.

Awards & highlights

T-MD Trial Summary

This trial will compare a targeted multidomain intervention to usual care in military-aged civilians with complex mTBI to see which is more effective.

Who is the study for?

This trial is for military-aged civilians (18-49) who've had a mild traumatic brain injury (mTBI) with symptoms like confusion, dizziness, or memory issues. They must have been diagnosed within the past 8 days to 6 months and have a Glascow coma scale score of at least 13. Exclusions include those with certain vestibular or neurological disorders, severe TBI history, pregnancy, legal actions related to mTBI, or previous participation in this study.Check my eligibility

What is being tested?

The study compares targeted multidomain interventions focusing on areas such as anxiety/mood, cognitive functions, migraines etc., against usual behavioral management care. It's designed to see if these specialized treatments are more effective for people with complex mTBI symptoms.See study design

What are the potential side effects?

Since the interventions involve non-pharmacological approaches like behavioral management and targeted therapies for specific symptoms (e.g., cognitive exercises), side effects may be minimal but could include discomfort from engaging in therapeutic activities.

T-MD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have experienced symptoms like confusion, dizziness, or memory problems possibly due to a mild brain injury.

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I was diagnosed with a severe concussion between 8 days and 6 months ago.

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My vision is normal or corrected to normal.

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I am between 18 and 49 years old.

T-MD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the bsi-18 will be measured from baseline to 3 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the bsi-18 will be measured from baseline to 3 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the bsi-18 will be measured from baseline to 3 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Functional Near-infrared Spectroscopy (fNIRS)

Neurobehavioral Symptom Inventory (NSI)

Patient Global Impression of Change (PGIC)

Secondary outcome measures

Behavioral Symptom Inventory (BSI-18)

Buffalo Concussion Treadmill Test (BCTT)

Clinical Profile Screening Inventory (CP Screen)

+10 more

T-MD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: T-MD Intervention GroupExperimental Treatment1 Intervention

Participants will be prescribed 1+ interventions tailored to affected domains.Anxiety/Mood-Cog beh therapy(CBT) for maladaptive beliefs/avoidance/coping behaviors. Graded exposure/activity/relaxation exercises, cognitive restructuring. Cognitive-Accommodations for reduced work/school time/delayed deadlines, more frequent/longer cognitive rest during symptom-provoking activities. Migraine/Headache: Education, relaxation training/mindfulness based therapy. Ocular-Exercises for ocular symptoms, near point convergence, may include Brock string, pencil push-ups, fixation, saccade tracking, pursuits. Sleep-Sleep regulation/hygiene. Mindfulness-based training, morning physical activity, CBT.Vestibular-Exercises for dizziness, visual motion sensitivity, gait, imbalance that may include gaze stability, visual habituation, static and dynamic balance/gait.Autonomic-Graded aerobic exercise. Perform daily aerobic exercise, goal 80% HR max on a stationary bike/treadmill/walking/jogging.

Group II: Behavioral ManagementActive Control1 Intervention

Participants in control group will receive standardized behavioral management strategies including: activity, hydration, nutrition, sleep, and stress management strategies. These strategies provide general methods to manage concussion symptoms and regulate daily activities to assist in the recovery of concussion. Clinicians will discuss and review a behavioral strategies handout with each participant and answer any questions they may have about the information in the handout. Contact time between clinicians and patients will be similar to avoid effects associated with more or less contact time.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED

865 Previous Clinical Trials

327,449 Total Patients Enrolled

Inova Health Care ServicesOTHER

69 Previous Clinical Trials

22,005 Total Patients Enrolled

University of PittsburghLead Sponsor

1,722 Previous Clinical Trials

16,342,696 Total Patients Enrolled

Media Library

Behavioral Management Clinical Trial Eligibility Overview. Trial Name: NCT04549532 — N/A

Traumatic Brain Injury Research Study Groups: T-MD Intervention Group, Behavioral Management

Traumatic Brain Injury Clinical Trial 2023: Behavioral Management Highlights & Side Effects. Trial Name: NCT04549532 — N/A

Behavioral Management 2023 Treatment Timeline for Medical Study. Trial Name: NCT04549532 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been recruited for involvement in this research endeavor?

"That's right. According to the information available on clinicaltrials.gov, this medical trial is still open and actively seeking volunteers for participation; it was first posted on June 15 2021 and last modified on June 3 2022 with a goal of enrolling 250 patients at 2 different sites."

Answered by AI

Are enrolments still open for this study?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial, which was initially posted on June 15th 2021 is currently enrolling volunteers. The goal of the study is to recruit 250 patients from two distinct sites."

Answered by AI

What are the intended outcomes of this medical experiment?

"This trial will utilise fNIRS to monitor Neurobehavioral Symptom Inventory (NSI) twice: at baseline and the 4 week visit. Modified Balance Error Scoring System (mBESS), Buffalo Concussion Treadmill Test (BCTT), as well as Short Form McGill Pain Questionnaire (SF-MPQ) are secondary outcomes that need to be tracked during this study period. mBESS involves three stances of 20 seconds each with a maximum score of 10 errors per stance while BCTT takes into account heart rate after 2 minutes of resting along with visual analog scale ratings for symptoms. SF-MPQ"

Answered by AI

Is the patient pool for this research limited to participants under a certain age?

"The requirements for participating in this clinical trial restrict the eligible age range to 18-49."

Answered by AI

Would I be eligible to partake in this medical experiment?

"This trial is looking to recruit 250 people aged between 18 and 49 who have recently experienced a brain concussion. In addition, applicants must be diagnosed with complex mTBI in the past 8 days-6 months with clear mechanism of injury, GCS score no less than 13 and reported or sign of mTBI including loss of consciousness, amnesia, disorientation/confusion, dizziness; plus normal vision; as well as complex mTBI-related symptoms and/or impairments in at least one of the following areas: anxiety/mood, cognitive, migraine, oculars vestibulars sleep or autonomic"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Targeted Multidomain (T-MD) Interventions for Complex Mild Traumatic Brain Injury (mTBI)

Anthony P. Kontos, Ph.D. 2021. "Targeted Multidomain (T-MD) Interventions for Complex Mild Traumatic Brain Injury (mTBI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04549532.

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