"Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"

Completed · Not applicable

Conditions studied: Traumatic Brain Injury, Post-Concussion Syndrome

In brief

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.

Key facts

Study ID

NCT01248390

Run by

The Defense and Veterans Brain Injury Center

People needed

48

Starts

2010-08-01

Expected to finish

2016-10-03

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Blast-related traumatic brain injury patients at least 3 months post injury with recovery to a Rancho los Amigos level 7 or 8 (alert and oriented).
• Brain injury documented by at least one of the following:
• i. loss of consciousness, post traumatic amnesia ii. alteration in mental status (dazed/confused), and/or physical evidence of iii.trauma (MRI/CT hemorrhage/contusion)
• A diagnosis of Postconcussional Disorder or Mild Neurocognitive Disorder Due to a General Medical Condition.
• Military or Veteran beneficiary
• Males and females aged 18-55

You may not qualify if…

• Current/prior (last 6 months) unstable medical condition that could affect current brain function (e.g. clear anoxic episode, cardiac arrest, current uncontrolled diabetes)
• Status post craniectomy prior to cranioplasty (must be 90 days post cranioplasty without surgical complication)
• Prior History of moderate to severe TBI (not including present injury).
• Current (last 3 months) active suicidal or homicidal ideation or intent.
• Current (last month) drug/alcohol abuse or dependence as determined by a score of 5 or higher on the Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
• Use of benzodiazepine or narcotic medications.
• Participation in a concurrent drug or treatment trial
• Must be physically able to complete the treatment tasks (including sensory functions).

Where it is running

• Warrior Recovery Center — Colorado Springs, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.