What is the mechanism of action of this treatment?

The most common treatments for Traumatic Brain Injury (TBI) that focus on improving story content and organization include narrative discourse therapy and other speech-language therapies. These treatments work by targeting the cognitive and linguistic deficits that often result from TBI, such as difficulties in organizing thoughts, constructing coherent narratives, and retrieving appropriate vocabulary. By systematically practicing storytelling and engaging in structured language exercises, patients can enhance their communication skills, which are crucial for social reintegration, return to work, and overall quality of life. This approach matters for TBI patients as it directly addresses the functional impairments that impact their daily interactions and personal relationships.

What side effects are associated with this type of intervention?

The Narrative Discourse Treatment for Traumatic Brain Injury (TBI) aims to improve communication by addressing story content and organization. Similar treatments often involve speech and language therapy, cognitive rehabilitation, and behavioral interventions. Common side effects of these therapies can include mental fatigue, frustration, and emotional distress due to the challenging nature of the exercises. Additionally, patients may experience temporary increases in confusion or memory difficulties as they work through complex cognitive tasks.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically targeting narrative discourse, story content, and organization for Traumatic Brain Injury (TBI). Most FDA-approved treatments for TBI focus on managing symptoms such as cognitive deficits, motor function impairments, and emotional disturbances. These treatments include medications like amantadine for cognitive improvement and various forms of rehabilitation therapy. The Narrative Discourse Treatment being studied aims to address specific communication impairments, which is a novel approach not yet covered by existing FDA-approved therapies.

What other types of research exist?

Promising, novel alternatives to Narrative Discourse Treatment for TBI patients include: 1) Transcranial Direct Current Stimulation (tDCS), which has shown potential in improving language and cognitive functions; 2) Computer-based cognitive rehabilitation programs, which offer personalized and adaptive training to enhance cognitive skills; and 3) Group therapy via videoconference, which increases access to treatment and has shown high compliance and satisfaction among patients.

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Narrative Discourse Treatment for Traumatic Brain Injury

N/A

Recruiting

Led By Karen Le, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Self-report of communication difficulty following TBI that interferes with activities

Veteran with diagnosis of TBI with mild to moderate functional cognitive impairments

Must not have

History of or current developmental disability (e.g., dyslexia), psychotic disorder, neurological illness (e.g., stroke, dementia, Parkinson's disease), aphasia or auditory processing disorder (APD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new therapy to help Veterans with TBI improve their storytelling skills. The therapy aims to make their stories better organized and more meaningful, which can help them communicate better in daily life. Storytelling interventions are increasingly being proposed as a tool for rehabilitation after Traumatic Brain Injury (TBI).

Who is the study for?

This trial is for Veterans with mild to moderate TBI who experience communication difficulties. They must have a significant other to report on their discourse ability, be able to engage in telehealth sessions, and have stable housing. Excluded are those with penetrating head injuries, developmental disabilities, psychotic disorders, neurological illnesses other than TBI, aphasia or APD, or recent substance abuse.

What is being tested?

The study tests a new narrative discourse treatment aimed at improving story content and organization for better daily communication in Veterans with TBI. It's evaluated based on tolerability and acceptability through telehealth sessions.

What are the potential side effects?

Since this is a non-medical intervention focusing on speech therapy techniques rather than drugs or surgery, traditional physical side effects are not expected; however participants may experience fatigue or frustration during the learning process.

Eligibility Criteria

Inclusion Criteria

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

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I have trouble communicating after a brain injury, affecting my daily activities.

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I am a veteran with a brain injury affecting my thinking or memory.

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I am a veteran diagnosed with mild to moderate traumatic brain injury.

Exclusion Criteria

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

Select...

I have a history of or currently have a developmental, psychotic, or neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 months

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

Treatment Details

Study Objectives

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

Primary study objectives

Acceptability of treatment as measured by a treatment satisfaction survey

Feasibility of treatment as measured by dropout rate in the treatment condition

Tolerability of treatment as measured by rates of attendance for all aspects of treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Discourse TreatmentExperimental Treatment1 Intervention

Biweekly discourse treatment sessions.

Group II: Treatment as UsualActive Control1 Intervention

No treatment. Participants will engage in their usual care.

0 / 4Eligibility 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) that focus on improving story content and organization include narrative discourse therapy and other speech-language therapies. These treatments work by targeting the cognitive and linguistic deficits that often result from TBI, such as difficulties in organizing thoughts, constructing coherent narratives, and retrieving appropriate vocabulary. By systematically practicing storytelling and engaging in structured language exercises, patients can enhance their communication skills, which are crucial for social reintegration, return to work, and overall quality of life. This approach matters for TBI patients as it directly addresses the functional impairments that impact their daily interactions and personal relationships.

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.