The Brave Initiative: Bringing Rehabilitation to American Veterans in an Enriched Environment — TBI  

Traumatic Brain Injury Clinical Trial

Official title: Harnessing Neuroplasticity to Promote Rehabilitation: Constraint-Induced (CI) Therapy for Traumatic Brain Injury (TBI)

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the value of Constraint-Induced Movement therapy (CIMT) for improving motor function and general fitness in adults with subacute and chronic traumatic brain injury (TBI), particularly TBI acquired during active military duty, in comparison to a Lakeshore Enriched Fitness Training (LEFT). The study will also test the effect of a set of enhanced versus "standard" procedures for transferring therapeutic gains from treatment setting to everyday life. Lastly, this study will determine whether any therapeutic effects observed are correlated with neuroplastic white matter or grey matter changes.

Clinical Trial Description

The proposed project is a prospective, randomized, controlled, single-blind study comparing the motor improvements resulting from Constraint-Induced Movement Therapy (CIMT) and Lakeshore Enriched Fitness Training (LEFT) for traumatic brain injury (TBI) in veterans and civilians. Over the course of two years, there will be a total of 80 subjects randomly assigned to 4 conditions. Treatment, testing, and follow-up testing will be carried out in the first 3 grant years and the 1-year follow-up will be completed in the fourth year. Clinical testing will be conducted at pre-treatment, post-treatment, and 1-year follow-up. Longitudinal neuroimaging studies to determine the treatment change in white matter, grey matter, and functional brain connectivity will be carried out across the above-noted time points by different diffusion tensor imaging (DTI) analysis variants, voxel-based morphometry (VBM) analysis of structural magnetic resonance imaging (MRI) scans, analysis of resting state functional MRI (fMRI), and analysis of fMRI during hand movement.

The 80 study participants will be randomly assigned in equal numbers to 1 of 4 arms: CIMT with Standard Transfer Package (sTP), CIMT with Enhanced Transfer Package (eTP), LEFT with sTP or LEFT with eTP. Forty volunteers will be tested on average per year. The patients will be classified into mild/moderate (Grade 2) and moderate motor deficits (Grades 3); a classification made at the impairment level based on standard active range of motion (AROM) criteria (further elaborated in "Eligibility Criteria").

The primary clinical outcome will be pre- to post-treatment change in a measure of use of the more-affected arm in daily life known as the Motor Activity Log. It is described in the outcomes section. As noted above, the response of the brain to the interventions will be examined using structural grey matter MRI analysis, DTI, and fMRI during resting state and during arm movement.

Each participant will have the option of being accompanied by a caregiver (travel and living expenses paid for by the project). The caregiver will be asked to complete the MAL independently of the participant. The same questionnaire administered to the patient will be administered to the caregiver. In addition, the caregiver will be shown how to help the patient carry out the home practice exercises so that they can do this during treatment and afterwards (if they remain in close contact with the participant). ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

• NCT number: NCT02339220
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Completion date: April 24, 2019