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

NCT01248390 | Completed

• 1 other identifier: A-14853.22
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Post-Concussion Syndrome

Keywords

traumatic brain injury; post-concussion

Outcome Measures

Primary Outcomes (1)

• Outcome Measure

  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.

  Six Months Post Treatment

Secondary Outcomes (1)

• Outcome Measure

  Six Months Post Treatment

Study Arms (2)

Interactive Metronome therapy

EXPERIMENTAL

Fifteen one-hour training sessions using Interactive Metronome system, in addition to treatment as usual.

Behavioral: Interactive metronome

Treatment as Usual

NO INTERVENTION

Standard of care symptom management.

Interventions

Interactive metronome BEHAVIORAL

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

Interactive Metronome therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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).

Sponsors & Collaborators

• The Defense and Veterans Brain Injury Center: lead

Study Sites (1)

Warrior Recovery Center

Colorado Springs, Colorado, 80913, United States

Location

Related Publications (1)

• 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.

  PMID: 24059443 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Renee M Pazdan, MD

  United States Public Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 25, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: October 3, 2016
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

US (1)