Treatment Trial for Balance Deficit due to Traumatic Brain Injury

A Double-Blind, Randomized, Sham-Controlled Study of the Safety and Effectiveness of the Portable Neuromodulation Stimulator (PoNS) 4.0 Device for Cranial Nerve Noninvasive Neuromodulation (CN-NINM) Training in Subjects with a Chronic Balance Deficit due to Mild-to-Moderate Traumatic Brain Injury (TBI)

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Tan, Ciara Natasha

    Trial Phone: 321.841.4129

  • IRB No: 15.008.01

    Protocol Abbrev: TBI-PoNS

    Principal Investigator: Linda Papa, MD

    Sub Investigators: Giordano, Philip MD; Weber, Kurt MD; Anica, Iordanca MD; Atienza, Jason MD; Morgan, Elizabeth PhD; Rodriguez-Spengler, Kenia PsyD; Conrad, Marissa PT; Repetto, Mariel PT; Laloo, Marla PT; Hinds, Robyn PT; Santiago, Leslie PT

    Phase: Device: Non-significant Risk

    Age Group: Adult

    Secondary Protocol No: NHC-TBI-PoNS-RT001

    Treatment: Physical Therapy

    Applicable Disease Sites: Brain

    Therapies Involved: Portable Neuromodulation Stimulator (PoNs); Physical Therapy exercises ID: NCT02429167

  • Objective

    The purpose of the research study is to test a potential treatment that combines the use of a device called the Portable Neuromodulation Stimulator (PoNS), with physical therapy exercises, to improve balance and walking in patients with mild or moderate traumatic brain injury.

  • Key Eligibility

    You may be eligible if you have experienced a mild or moderate traumatic brain injury; have difficulty with balance and walking; are at least 1 year post injury; are between the ages 18 and 65; are able to walk for 20 minutes on a treadmill