"Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"
Condition: Traumatic Brain Injury; Post-Concussion Syndrome
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Wounds and Injuries
Study type: Interventional

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.
    

Detailed description: 
      The design of this study will be a randomized, controlled trial of Interactive Metronome (IM)
      treatment compared with treatment as usual in patients with moderate to mild Traumatic Brain
      Injury (TBI) due to blast. The study will be conducted at the Evans Army Community Hospital
      at Fort Carson, Colorado . 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 electroencephalogram (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.
    

Intervention name(s): Interactive metronome
Intervention type(s): Behavioral
Intervention description(s): A randomized, controlled investigation into the effects of IM training on a sample of boys with attention deficit disorder showed positive results. Compared to an active control treatment, IM training improved performance on a host of measures, including attention, motor control, language processing, reading, and parental reports of improvements in the regulation of aggressive behavior.16 It should be noted that these cognitive and behavioral functions are common symptom areas in individuals surviving TBI and are likely to be especially affected in cases of blast injury
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: traumatic brain injury; post-concussion