"Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||"A Randomized, Controlled, Trial of Interactive Metronome Technology for Remediation of Cognitive Difficulties Following Blast-Related Traumatic Brain Injury"|
- Outcome Measure [ Time Frame: Six Months Post Treatment ] [ Designated as safety issue: No ]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.
- Outcome Measure [ Time Frame: Six Months Post Treatment ] [ Designated as safety issue: No ]Determine whether the addition of Interactive Metronome training leads to better secondary outcomes such as postconcussion symptom status, vocational functioning, and quality of life at 6 months in comparison to treatment as usual.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Behavioral: Interactive metronome
The design of this study will be a randomized, controlled trial of IM compared with treatment as usual in patients with moderate to mild TBI due to blast. The study will be conducted at the Evans Army Community Hospital at Fort Carson, CO . Patients will be randomized to IM training, or to a treatment as usual/wait-list control condition. Patients randomized to receive IM training will complete 15 sessions consisting of approximately 2000 repetitions each. Patients randomized to treatment as usual will be offered the opportunity to receive IM training following the conclusion of the six month study period. Outcome assessment will focus on phase lag and coherence of EEG activity, which are electrophysiological measures of cortical connectivity. Primary outcomes will also include attention and memory functioning, which are measured prior to the start of treatment, one week following the end of treatment and 6 months after treatment ends.
Interactive Metronome (IM) technology is a behavioral feedback operant conditioning system.15 In biofeedback, physiological information is displayed to the patient but with IM information about the patient's behavioral responses is provided to them. Below the investigators provide a detailed description of the behavioral tasks and give some idea as to the program's complexity and operation. IM technology takes advantage of each of the above discussed factors related to neuroplastic processes and integrates them into a single set of tasks that are designed to encourage integrated neuroplastic activity under cognitively demanding circumstances. The computerized feedback is reliable, consistent, timely, and directly correlated with motor output. The feedback is also presented in a rich cognitive and sensory environment that combines instantaneous delivery of simultaneous auditory and visual feedback following the motor response. This information aids the preparation of the upcoming behavioral response. All of this feedback processing and adjustment of behavioral responses must occur in just over a second (1.111 seconds) because the default tempo for IM training is 54 beats per minute. This places a considerable temporal demand upon the attentional, integration, decision making, inhibitory, and motor output operators of the cortex, thereby increasing processing speed and efficiency over the course of training.
|Contact: Karen E. Schardin, BS, BS||719 526 email@example.com|
|Contact: Lonnie Nelson, PhD||719 526 firstname.lastname@example.org|
|United States, Colorado|
|Warrior Recovery Center||Recruiting|
|Colorado Springs, Colorado, United States, 80918|
|Contact: Karen E Schradin, BS 719-526-8636 email@example.com|
|Contact: Lonnie Nelson, PhD 719-526-8636 firstname.lastname@example.org|
|Principal Investigator: Karl Brewer, MAJ|