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NCT01248390 · ClinicalTrials.gov registry record · NA
"Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"
A NA study of Traumatic Brain Injury and Post-Concussion Syndrome, sponsored by The Defense and Veterans Brain Injury Center.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01248390: Completed NA study of Traumatic Brain Injury and Post-Concussion Syndrome, sponsored by The Defense and Veterans Brain Injury Center.
NCT01248390 is a NA study of Traumatic Brain Injury and Post-Concussion Syndrome that has completed, run by The Defense and Veterans Brain Injury Center. The registered enrollment target is 48 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01248390, a NA study of Traumatic Brain Injury and Post-Concussion Syndrome, has completed, sponsored by The Defense and Veterans Brain Injury Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research is to see whether adding a new therapy helps people with brain injury focus better and think more clearly. You are being asked to participate in this research study because you have had a brain injury. If you decide to volunteer, you will be in the study for about six months.As a participant, you will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means you will have a chance of being assigned to either of the plans. One group will be given an experimental therapy using a metronome one hour a day, three times a week. A metronome is a device that produces a steady beat. You will need to keep time with the metronome doing several different movements. On each beat, you will be given information both through sound and on a computer screen about whether you were early or late and how far off beat you were. The tempo of the beat will be at 54 beats per minute, so you will need to process the feedback information very quickly to adjust your speed up or down to match the beat. The various movements include things like clapping hands, tapping toes, or alternating between different similar movements. It is hoped that the metronome will help subjects to concentrate better.
Primary Outcome
Determine whether IM training leads to improvements in attention and memory immediately post treatment and at six months in comparison to rehabilitation treatment as usual.
Conditions Studied
Interventions
- BEHAVIORAL Interactive metronome
Study Locations (1)
Colorado
- Warrior Recovery Center - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2010-08 |
| Est. Completion | 2016-10-03 |
| Phase | NA |
What the finished NCT01248390 record still lists
NCT01248390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which Interactive metronome is the first listed.
NCT01248390 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01248390 about?
NCT01248390 is a clinical study titled ""Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"". The purpose of this research is to see whether adding a new therapy helps people with brain injury focus better and think more clearly. You are being asked to participate in this research study because you have had a brain injury. If you decide to volunteer, you will be in the study for about six mo...
What is the current status of trial NCT01248390?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2010-08. Estimated completion is 2016-10-03.
What conditions does trial NCT01248390 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Post-Concussion Syndrome.
What interventions are being tested in trial NCT01248390?
The interventions under investigation include: Interactive metronome (BEHAVIORAL).
Who is sponsoring clinical trial NCT01248390?
This trial is sponsored by The Defense and Veterans Brain Injury Center, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01248390 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01248390's enrollment target sits among peer trials
48 122nd of 171 higher than 50 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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