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Targeted Multidomain for Mild Traumatic Brain Injury (MTBI)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mild Traumatic Brain Injury (MTBI)Targeted Multidomain - Behavioral
Eligibility
18 - 49
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Mild Traumatic Brain Injury (MTBI)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
On-field activity group - Aim 3
1
Rest
1
Catalyst Cryohelmet

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: The BSI-18 will be measured from baseline to 3 months.

Month 3
ID Migraine
Week 4
Immediate Post-concussion Assessment and Cognitive Testing (ImPACT)
Month 3
Neurobehavioral Symptom Inventory (NSI)
Week 4
Buffalo Concussion Treadmill Test (BCTT)
Month 3
Behavioral Symptom Inventory (BSI-18)
Month 3
Clinical Profile Screening Inventory (CP Screen)
Month 3
Dizziness Handicap Inventory (DHI)
Week 4
Functional Gait Assessment (FGA)
Month 3
Headache Impact Test (HIT-6)
Month 3
International Physical Activity Questionnaire (IPAQ)
Month 3
Patient Global Impression of Change (PGIC)
Month 3
Pittsburgh Sleep Quality Index (PSQI)
Month 3
Short Form McGill Pain Questionnaire (SF-MPQ)
Week 4
Vestibular Ocular Motor Screening (VOMS)
Week 4
Functional Near-infrared Spectroscopy (fNIRS)
Week 4
Modified Balance Error Scoring System (mBESS)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
On-field activity group - Aim 3
1
Rest
1
Catalyst Cryohelmet

Trial Design

2 Treatment Groups

Behavioral Management
1 of 2
T-MD Intervention Group
1 of 2

Active Control

Experimental Treatment

250 Total Participants · 2 Treatment Groups

Primary Treatment: Targeted Multidomain · No Placebo Group · N/A

T-MD Intervention Group
Behavioral
Experimental Group · 1 Intervention: Targeted Multidomain · Intervention Types: Behavioral
Behavioral Management
Behavioral
ActiveComparator Group · 1 Intervention: Behavioral Management · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: the bsi-18 will be measured from baseline to 3 months.

Who is running the clinical trial?

Inova Health Care ServicesOTHER
63 Previous Clinical Trials
18,048 Total Patients Enrolled
1 Trials studying Mild Traumatic Brain Injury (MTBI)
70 Patients Enrolled for Mild Traumatic Brain Injury (MTBI)
United States Department of DefenseFED
778 Previous Clinical Trials
202,272 Total Patients Enrolled
3 Trials studying Mild Traumatic Brain Injury (MTBI)
737 Patients Enrolled for Mild Traumatic Brain Injury (MTBI)
University of PittsburghLead Sponsor
1,617 Previous Clinical Trials
16,295,192 Total Patients Enrolled
3 Trials studying Mild Traumatic Brain Injury (MTBI)
697 Patients Enrolled for Mild Traumatic Brain Injury (MTBI)
Anthony P Kontod, PhDPrincipal InvestigatorUniversity of Pittsburgh

Eligibility Criteria

Age 18 - 49 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 18 and 49.
You have normal or corrected vision.
You have a complex mTBI-related symptom or impairment in at least one of the following areas: anxiety/mood, cognitive, migraine, ocular, vestibular, sleep, autonomic.
References

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