"Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"
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|ClinicalTrials.gov Identifier: NCT01248390|
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : June 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Post-Concussion Syndrome||Behavioral: Interactive metronome||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||"A Randomized, Controlled, Trial of Interactive Metronome Technology for Remediation of Cognitive Difficulties Following Blast-Related Traumatic Brain Injury"|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||October 3, 2016|
Experimental: Interactive Metronome therapy
Fifteen one-hour training sessions using Interactive Metronome system, in addition to treatment as usual.
Behavioral: Interactive metronome
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
No Intervention: Treatment as Usual
Standard of care symptom management.
- Outcome Measure [ Time Frame: Six Months Post Treatment ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248390
|United States, Colorado|
|Warrior Recovery Center|
|Colorado Springs, Colorado, United States, 80913|
|Principal Investigator:||Renee M Pazdan, MD||United States Public Health Service|