Treatment and Recovery Monitoring of Post TBI Symptoms

Not Applicable

Completed

• Conditions: Brain Injuries, Traumatic
• Interventions: Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS); Device: Active repetitive Transcranial Magnetic Stimulation (rTMS)

• Registration Number: NCT02426749
• Lead Sponsor: University of Manitoba

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2015-04-16
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Study Start: 2015-09
• Status Verified: 2016-10
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Results First Submitted: 2019-09-27
• Results First Submitted QC: 2020-01-02
• Results First Posted: 2020-01-18
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham repetitive Transcranial Magnetic Stimulation (rTMS)	Participants of this arm will receive sham rTMS intervention (treatment).
Active Coil	Active repetitive Transcranial Magnetic Stimulation (rTMS)	Participants of this arm will receive active rTMS intervention (treatment).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in RPQ Score at Post-treatment Sessions	Immediately following treatment (4 weeks after baseline)	RPQ is the Rivermead Post Concussion Symptoms Questionnaire. Scale ranges from 0 to 64 points, with higher scores representing a greater number or severity of reported symptoms.
Change From Baseline in EVestG Field Potential's Features at Post Treatment Sessions	Immediately following treatment (4 weeks after baseline)	EVestG is the Electrovestibulography assessment, in which features of the neural field potential are extracted. The measurement here is a calculation of the area under the AP curve. The area is a product of the number of samples (1 / 41667 s each) and the normalized voltage (normalized so the field potential peak has a magnitude of 1). The result is summed over all detected field potentials. Due to the normalization, in a practical sense this value gives a metric of how wide or narrow the calculated field potential shape is.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in MADRS Score at Post-treatment Sessions	Immediately following treatment (4 weeks after baseline)	MADRS is the Montgomery Asberg Depression Rating Scale. Scores range from 0 to 60, with higher scores meaning that the subject has a higher degree of depression.
Change From Baseline in MoCA Score at Post-treatment Sessions.	Immediately following treatment (4 weeks after baseline)	MoCA is the Montreal Cognitive Assessment; the scale ranges from 0 to 30 points. Higher scores indicate a higher cognitive ability.

Trial Locations

Locations (1)

Riverview Health Center; 🇨🇦 Winnipeg, Manitoba, Canada