Status:
COMPLETED
"Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"
Lead Sponsor:
The Defense and Veterans Brain Injury Center
Conditions:
Traumatic Brain Injury
Post-Concussion Syndrome
Eligibility:
All Genders
18-55 years
Phase:
NA
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 becaus...
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) ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01248390
Start Date
August 1 2010
End Date
October 3 2016
Last Update
June 20 2017
Active Locations (1)
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1
Warrior Recovery Center
Colorado Springs, Colorado, United States, 80913