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NCT06561100 · ClinicalTrials.gov registry record · NA
Treatment Optimization of Brain-injured Warfighters
A NA study of Mild Traumatic Brain Injury, sponsored by United States Naval Medical Center, San Diego.
- Recruiting
- Registry status
- NA
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT06561100: Recruiting NA study of Mild Traumatic Brain Injury, sponsored by United States Naval Medical Center, San Diego.
NCT06561100 is a NA study of Mild Traumatic Brain Injury that is actively recruiting participants, run by United States Naval Medical Center, San Diego. The registered enrollment target is 140 participants, below the 217-participant average among 43 other Mild Traumatic Brain Injury trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06561100, a NA study of Mild Traumatic Brain Injury, is actively recruiting participants, sponsored by United States Naval Medical Center, San Diego.
- RECRUITING
- Registry status
- NA
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
Prescribed sub-symptomatic adaptable exercise treatment (SAET) is a potential solution that promotes recovery needs following a TBI. SAET has been shown to benefit the mind and body in ways that decrease the severity and frequency of mild TBI (mTBI) symptoms. This study aims to validate SAET as an alternative, adaptable treatment or SMs with mTBI that focuses on reducing symptoms, improving mental health, increasing physiological functioning, and ultimately returning to duty. The objective of this study is to develop a prescribed exercise treatment program for warfighters with mTBI that can be personalized for SM's needs (i.e., medical and occupational) and is adaptable to various clinical resources (e.g., forward operating bases, rural clinics, and mTBI specialty programs). The key question raised by this study is whether SAET is more effective than a stretching control group (SCG) in reducing neurobehavioral symptoms among SMs with persistent complaints following a mTBI.
Primary Outcome
Change in the Neurobehavioral Symptoms Inventory (NSI) from pre- to post-SAET. Neurobehavioral symptoms will be assessed using the Neurobehavioral Symptom Inventory (NSI) which captures multiple neurobehavioral symptoms including cognitive, somatosensory, vestibular, and affective. Furthermore, this 22 item self-report questionnaire is well validated in research studies on TBI in military populations, it has known reliability and validity, as well as guidelines for assessment of change.
Conditions Studied
Interventions
- BEHAVIORAL Sub-symptomatic Adaptable Exercise Treatment (SAET)
- BEHAVIORAL Stretching Control Group (SCG)
Study Locations (1)
California
- Intrepid Spirit Center - Camp Pendleton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2023-09-27 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT06561100 shows while recruiting
NCT06561100 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 217-participant average among 43 other Mild Traumatic Brain Injury trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Mild Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Sub-symptomatic Adaptable Exercise Treatment (SAET) is the first listed.
NCT06561100 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06561100 about?
NCT06561100 is a clinical study titled "Treatment Optimization of Brain-injured Warfighters". Prescribed sub-symptomatic adaptable exercise treatment (SAET) is a potential solution that promotes recovery needs following a TBI. SAET has been shown to benefit the mind and body in ways that decrease the severity and frequency of mild TBI (mTBI) symptoms. This study aims to validate SAET as an a...
What is the current status of trial NCT06561100?
This trial is currently recruiting. It is a NA study. The enrollment target is 140 participants. The study started on 2023-09-27. Estimated completion is 2026-09.
What conditions does trial NCT06561100 study?
This clinical trial studies the following conditions: Mild Traumatic Brain Injury.
What interventions are being tested in trial NCT06561100?
The interventions under investigation include: Sub-symptomatic Adaptable Exercise Treatment (SAET) (BEHAVIORAL), Stretching Control Group (SCG) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06561100?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06561100 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06561100's enrollment target sits among peer trials
140 17th of 43 higher than 27 of 43 other Mild Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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