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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights

Study Summary

This trial is testing a new treatment for discourse impairments, which are difficulties with communication beyond single sentences. The treatment is designed to improve story content and organization, and the trial will evaluate whether it is feasible and acceptable to participants. If the treatment is effective, it has the potential to improve communication for Veterans with TBI, which could lead to improvements in their overall quality of life.

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.Check my eligibility
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.See study design
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.

Timeline

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

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

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.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,144 Total Patients Enrolled
Karen Le, PhDPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT

Media Library

Narrative discourse treatment Clinical Trial Eligibility Overview. Trial Name: NCT05008419 — N/A
Traumatic Brain Injury Research Study Groups: Discourse Treatment, Treatment as Usual
Traumatic Brain Injury Clinical Trial 2023: Narrative discourse treatment Highlights & Side Effects. Trial Name: NCT05008419 — N/A
Narrative discourse treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05008419 — N/A

Frequently Asked Questions

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

Are there still vacancies for individuals to participate in this clinical trial?

"Clinicaltrials.gov indicates that this medical trial has concluded its recruitment, the initial post being made on January 1st 2023 and last updated on July 25th 2022. Although no longer open to new participants, there are 325 other studies looking for volunteers at present."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Narrative Discourse Treatment Development
2023. "Narrative Discourse Treatment Development". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05008419.
All > Tbi > Traumatic Brain Injury
~27 spots leftby Sep 2026
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