Clinical trial NCT02426749: Treatment and Recovery Monitoring of Post TBI Symptoms
Official title: Treatment and Recovery Monitoring of Post Traumatic Brain Injury (TBI) Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-04-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria for patients:

1. Participants must be of age 18-70 years, and have had TBI in the last 12 months prior to inclusion and presence of persistent TBI symptoms at the time of inclusion as confirmed by the co-investigator physicians.

Exclusion Criteria:

1. Use of neuro- or psycho-active medications as published in recommendations
2. Active use of illicit drugs
3. History of epilepsy
4. History of any other brain lesions including tumors, infectious, vascular, or metabolic lesions
5. Severe or recent heart diseases
6. Alcoholism
7. Pregnancy
8. The presence of metallic objects in the body; dental implants are fine but people with pacemakers are to be excluded; anything that is unsafe under MRI would be considered unsafe for TMS \[26\].
9. Lack of ability to adequately communicate (understand, read, speak) in English and understand the experimental protocol.
10. Pending litigation (i.e., patients with pending actions regarding disability reports, litigation, or other kinds of financial compensation).

Primary outcomes:
measure: Change From Baseline in RPQ Score at Post-treatment Sessions
timeFrame: Immediately following treatment (4 weeks after baseline)
measure: Change From Baseline in EVestG Field Potential's Features at Post Treatment Sessions
timeFrame: Immediately following treatment (4 weeks after baseline)
Secondary outcomes:
measure: Change From Baseline in MoCA Score at Post-treatment Sessions.
timeFrame: Immediately following treatment (4 weeks after baseline)
measure: Change From Baseline in MADRS Score at Post-treatment Sessions
timeFrame: Immediately following treatment (4 weeks after baseline)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Riverview Health Center
state: Manitoba
Study officials:
References:
citation: Moussavi Z, Suleiman A, Rutherford G, Ranjbar Pouya O, Dastgheib Z, Zhang W, Salter J, Wang X, Mansouri B, Lithgow B. A Pilot Randomised Double-Blind Study of the Tolerability and efficacy of repetitive Transcranial Magnetic Stimulation on Persistent Post-Concussion Syndrome. Sci Rep. 2019 Apr 2;9(1):5498. doi: 10.1038/s41598-019-41923-6.