Clinical trial NCT01248390: "Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"
Official title: "A Randomized, Controlled, Trial of Interactive Metronome Technology for Remediation of Cognitive Difficulties Following Blast-Related Traumatic Brain Injury"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Post-Concussion Syndrome
Keywords: traumatic brain injury
post-concussion
Lead sponsor: The Defense and Veterans Brain Injury Center
Sponsor class: FED
First posted: 2010-11-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 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).
2. 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)
3. A diagnosis of Postconcussional Disorder or Mild Neurocognitive Disorder Due to a General Medical Condition.
4. Military or Veteran beneficiary
5. Males and females aged 18-55

Exclusion Criteria:

1. Current/prior (last 6 months) unstable medical condition that could affect current brain function (e.g. clear anoxic episode, cardiac arrest, current uncontrolled diabetes)
2. Status post craniectomy prior to cranioplasty (must be 90 days post cranioplasty without surgical complication)
3. Prior History of moderate to severe TBI (not including present injury).
4. Current (last 3 months) active suicidal or homicidal ideation or intent.
5. 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)
6. Use of benzodiazepine or narcotic medications.
7. Participation in a concurrent drug or treatment trial
8. Must be physically able to complete the treatment tasks (including sensory functions).

Primary outcomes:
measure: Outcome Measure
timeFrame: Six Months Post Treatment
Secondary outcomes:
measure: Outcome Measure
timeFrame: Six Months Post Treatment
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Warrior Recovery Center
state: Colorado
Study officials:
affiliation: United States Public Health Service
name: Renee M Pazdan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nelson LA, Macdonald M, Stall C, Pazdan R. Effects of interactive metronome therapy on cognitive functioning after blast-related brain injury: a randomized controlled pilot trial. Neuropsychology. 2013 Nov;27(6):666-79. doi: 10.1037/a0034117. Epub 2013 Sep 23.