N/A
N=22
Treatment and Recovery Monitoring of Post TBI Symptoms
Brain Injuries, Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT02426749 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change From Baseline in RPQ Score at Post-treatment Sessions — -4.6; -3.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active repetitive Transcranial Magnetic Stimulation (rTMS) (Device); Sham repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Manitoba
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in RPQ Score at Post-treatment Sessions |
-4.6; -3.4 | — |
| PRIMARY Change From Baseline in EVestG Field Potential's Features at Post Treatment Sessions |
5.64; 3.08 | — |
| SECONDARY Change From Baseline in MoCA Score at Post-treatment Sessions. |
0.33; 0.67 | — |
| SECONDARY Change From Baseline in MADRS Score at Post-treatment Sessions |
-3.22; -2.33 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria for patients:
- 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
- Use of neuro- or psycho-active medications as published in recommendations
- Active use of illicit drugs
- History of epilepsy
- History of any other brain lesions including tumors, infectious, vascular, or metabolic lesions
- Severe or recent heart diseases
- Alcoholism
- Pregnancy
- 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].
- Lack of ability to adequately communicate (understand, read, speak) in English and understand the experimental protocol.
- Pending litigation (i.e., patients with pending actions regarding disability reports, litigation, or other kinds of financial compensation).
Data sourced from ClinicalTrials.gov (NCT02426749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.