NCT07463027

Brief Summary

The goal of this clinical trial is to learn if the Avalon Action Alliance Interdisciplinary Outpatient Rehabilitation Program (IORP) can reduce long-lasting symptoms of traumatic brain injury (TBI) and co-occurring disorders in veterans and first responders. The main questions it aims to answer are:

  • Does a 3-week IORP reduce symptoms of long-lasting TBI and co-occurring disorders in military veterans and first responders?
  • Does the 3-week IORP improve life quality and function in military veterans and first responders? Researchers will compare the Control group to the Invention group to see if a 3-week of IORP reduced symptoms of TBI and co-occurring disorders in military veterans and first responders. Participants will complete the following activities. The items with an asterisk(\*) are not required or available at all sites.
  • Answer online survey questions about their TBI symptoms, life satisfaction, and life activities
  • Complete two blood draws\*
  • Complete two magnetic resonance imaging (MRI) brain scans\*

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026May 2029

First Submitted

Initial submission to the registry

February 27, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

March 26, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

February 27, 2026

Last Update Submit

March 27, 2026

Conditions

Traumatic Brain Injury and Co-occurring Disorders

Keywords

Traumatic Brain InjuryVeteransFirst RespondersTBIInterdisciplinary Outpatient Rehabilitation ProgramIORP

Outcome Measures

Primary Outcomes (1)

  • Mean change in Neurobehavioral Symptom Inventory (NSI)

    The NSI is a 22-item self-report questionnaire used to assess neurobehavioral symptoms, particularly those following a TBI

    Baseline enrollment to 3-month follow-up (post IORP)

Secondary Outcomes (3)

  • Mean change in Satisfaction with Life Scale (SWLS)

    Baseline enrollment to 3 months post-IORP and 6 months post-IORP

  • Life Satisfaction Questionnaire (LISAT-11)

    Baseline enrollment to 3 months post-IORP and 6 months post-IORP

  • Participation Assessment with Recombined Tools-Objective (PART-O)

    Baseline enrollment to 3 months post-IORP and 6 months post-IORP

Study Arms (2)

Interdisciplinary Outpatient Rehabilitation Program Intervention Arm

OTHER

Participants in this arm will start the 3-Week TBI IORP after baseline evaluation and receiving the recommendation to participate in the IORP.

Behavioral: 3-week interdisciplinary outpatient rehab program (IORP)

Control Waiting Period Arm

OTHER

Participants in this arm will start the 3-Week TBI IORP after observing at least a 3 month waiting period after baseline evaluation and receiving the recommendation to participate in the IORP.

Behavioral: 3-week interdisciplinary outpatient rehab program (IORP)

Interventions

3-week interdisciplinary outpatient rehab program (IORP)BEHAVIORAL

Interdisciplinary outpatient rehabilitation program (IORP) for military veterans and first responders experiencing chronic effects of traumatic brain injury (TBI) and co-occurring disorders (e.g., posttraumatic stress disorder, depression, substance use).

Control Waiting Period ArmInterdisciplinary Outpatient Rehabilitation Program Intervention Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets general eligibility requirements for site specific 3-week IORP
  • Capable of providing informed consent for IORP and study participation
  • English speaking
  • to 65 years old

You may not qualify if:

  • History of TBI of any severity in the past 6 months
  • Active substance use disorder that precludes study participation
  • Neurologic, psychiatric, or other medical condition that would prohibit full study participation
  • Active-duty military service member
  • Any other circumstance that, in the opinion of the investigator, would undermine the integrity or success of the project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BRAVE Program

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurosurgery

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 10, 2026

Study Start

March 26, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)