What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) include medications, rehabilitation therapies, and supportive services. Medications may include pain relievers, anti-seizure drugs, and medications to reduce intracranial pressure, which can have side effects such as dizziness, drowsiness, and gastrointestinal issues. Rehabilitation therapies, including physical, occupational, and speech therapy, generally have fewer side effects but may cause fatigue and emotional stress. Comprehensive support services, like those in the RCBI trial, aim to address the unique needs of TBI patients and may include case management, counseling, and vocational training. These services are generally well-tolerated but can sometimes lead to emotional and psychological challenges as individuals adjust to their new routines and cope with their injuries.

What prior FDA approvals exist?

There are no specific FDA-approved treatments that directly align with the comprehensive support services approach of the Reentry Continuum for Brain Injury (RCBI) trial, which focuses on tailored services to facilitate reentry and reduce recidivism for individuals with TBI. However, various pharmacologic treatments for acute TBI are being studied in clinical trials, and supportive care remains a critical component of TBI management. These supportive measures often include rehabilitation services, cognitive therapy, and other multidisciplinary approaches to address the complex needs of TBI patients.

What other types of research exist?

Promising novel alternatives to the Reentry Continuum for Brain Injury (RCBI) for TBI patients include: 1) Computerized EBIS Protocol: A standardized, internet-based data exchange system for tracking and managing TBI patient rehabilitation. 2) Neuromodulation Techniques: Transcranial Magnetic Stimulation (TMS) and Transcranial Direct-Current Stimulation (tDCS) have shown efficacy in improving cognitive and mood symptoms in TBI patients. 3) Regenerative Hydrogels: Emerging research suggests that hydrogels may support brain tissue regeneration and repair following TBI. These alternatives offer innovative approaches to enhance the rehabilitation and reentry process for TBI patients.

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RCBI Program for TBI Recidivism Reduction (RCBI Trial)

N/A

Recruiting

Led By Devan Parrott, PhD

Research Sponsored by Rehabilitation Hospital of Indiana

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18 and older

Be older than 18 years old

Must not have

Individuals requiring a legally authorized representative (LAR)

Inability to comprehend the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 weeks, 3 months

Awards & highlights

Summary

This trial aims to help people with brain injuries who are being released from prison by providing a special program that supports their unique needs. The goal is to reduce their chances of going back to prison and committing violent crimes by offering tailored services that help them manage their behavior and integrate into the community.

Who is the study for?

This trial is for adults with a history of moderate to severe traumatic brain injury (TBI) who are currently serving sentences at PCF in Greencastle, Indiana and have 5 to 8 months left in their sentence. It's not for those in solitary confinement or unable to understand the study.

What is being tested?

The trial tests if the Reentry Continuum for Brain Injury (RCBI) program can reduce re-incarceration and violent offenses among TBI patients post-release. Participants will be randomly assigned to RCBI or typical aftercare and tracked for three years.

What are the potential side effects?

Since this intervention involves social support services rather than medication, traditional side effects aren't expected. However, participants may experience varying psychological impacts from involvement in the program.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need someone legally authorized to make decisions for me.

Select...

I understand the details of the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Attributions of Intent Hostility Questionnaire (AIHQ)

Change in Behavioral Infractions

Change in Brain Injury Coping Skills Questionnaire (BICS-Q)

+6 more

Secondary study objectives

Change in Behavioral Rating Inventory of Executive Function-Adult Version (BRIEF-A)

Level of Service Inventory - Revised (LSI-R)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RCBIExperimental Treatment1 Intervention

Receiving RCBI intervention, including BICS, ICAN, and RF.

Group II: Treatment as usual- Control groupActive Control1 Intervention

Not receiving the RCBI intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Traumatic Brain Injury (TBI) include multidisciplinary rehabilitation, cognitive-behavioral therapy (CBT), and community-based support services. Multidisciplinary rehabilitation involves a team of healthcare professionals who address the physical, cognitive, and emotional aspects of TBI, promoting overall recovery and functional independence. CBT helps patients modify negative thought patterns and behaviors, improving coping strategies and reducing symptoms of anxiety and depression. Community-based support services provide tailored assistance to help individuals reintegrate into society, addressing unique needs such as vocational training, social skills development, and mental health support. These treatments are crucial for TBI patients as they facilitate comprehensive recovery, enhance quality of life, and reduce the risk of recidivism by addressing the multifaceted challenges faced by individuals with TBI.

The effectiveness of traumatic brain injury rehabilitation: a review.Randomized Controlled Trials of Rehabilitation Services in the Post-acute Phase of Moderate and Severe Traumatic Brain Injury - A Systematic Review.Neurotherapeutic capacity of P7C3 agents for the treatment of Traumatic Brain Injury.