Treatment and Recovery Monitoring of Post TBI Symptoms
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      This proposal aims to investigate the effect of a promising treatment for persistent post
      Traumatic Brain Injury (TBI) symptoms, and to monitor TBI patient's recovery by an objective
      technique along with standard clinical assessments. The treatment tool is the application of
      repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex
      (DLPFC) of the brain. The treatment efficacy and monitoring TBI patients' recovery will be
      objectively assessed using Electrovestibulography (EVestGTM); this will be in parallel with
      clinical and standard assessments.
    

Detailed description: 
      TBI is a significant health problem mainly because of its plausible prolonged sequelae and
      lack of objective measures for recovery. The conventional treatment after a TBI is physical
      rehabilitation that helps with motor functional recovery. However, there are usually some
      disabling persistent post-TBI symptoms (mostly neurological) that do not respond to the
      current clinical and physical rehabilitation. rTMS, on the other hand, is a promising,
      well-tolerated, non-invasive brain neuromodulation technique that has emerged as a
      therapeutic tool for a variety of neurological conditions. Thus, the researchers' aim to
      investigate the effect of rTMS treatment on post-TBI symptoms in patients identified by the
      medical collaborators (Drs. Mansouri and Salter). Equally important is to have an objective
      measure of treatment efficacy and patient's symptoms recovery. EVestGTM is a noninvasive
      technique to record neural activity from the vestibular apparatus and vestibular nuclei in
      the external ear. After a head injury, people commonly experience balance (vestibular)
      problems and dizziness, as well as confused thinking. Considering the well-known
      bidirectional anatomical links of the vestibular system, following an impact TBI, EVestG
      signals are expected to change, and our pilot studies show a great potential of EVestG to
      monitor the impact of TBI. Thus, the researchers aim to use EVestG as an objective measure to
      monitor the recovery path during and after the rTMS treatment in parallel to clinical and
      neuro-psychological assessments.
    

Intervention name(s): Active repetitive Transcranial Magnetic Stimulation (rTMS); Sham repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention type(s): Device; Device
Intervention description(s): The treatments will be administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups will undergo rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC bilaterally at 100% of the resting motor threshold. Thus, there will be a total of 1500 pulses per two sides of the brain per day, which is well within the safety limit of the rTMS application. During the intertrain intervals, the patients will be presented a series of objects and actions and asking to name them. The images will be projected on the wall in front of patient with duration of three seconds for each image. The aim is to keep the brain active while we stimulate it with rTMS.; Sham rTMS is similar to Active rTMS but instead of a real coil, it uses a coil that attenuates the pulses such that no current will be induced in the brain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment