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Behavioural Intervention
Active rTMS for Traumatic Brain Injury
N/A
Waitlist Available
Led By Theresa Pape, DrPH, MA
Research Sponsored by Edward Hines Jr. VA Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in docs-25 score at 7 days, 14 days, 21 days, 28 days and 50 days
Awards & highlights
Study Summary
This trial is studying the effects of a brain stimulation treatment called repetitive transcranial magnetic stimulation (rTMS) on people who have remained in a vegetative or minimally conscious state for 3-24 months after a severe traumatic brain injury (TBI).
Eligible Conditions
- Traumatic Brain Injury
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline in consciousness level at 7 days, 14 days, 21 days, 28 days and 50 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in consciousness level at 7 days, 14 days, 21 days, 28 days and 50 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disability Rating Scale
Secondary outcome measures
Coma Near Coma Scale
Coma Recovery Scale-Revised
Consciousness Screening Algorithm
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active rTMSExperimental Treatment1 Intervention
The intervention consists of 30 active rTMS sessions. Each session is comprised of 300 trains of paired pulses with the following parameters: 100µs paired pulses separated by 100ms inter-pulse-intervals and a five second inter-train-interval. Pulse intensity will be set at 110% of each participant's motor threshold. Active rTMS sessions will be provided two times per day with a 70mm figure-of-eight coil over the left dorsolateral prefrontal cortex. Two Magstim-2002 units and a Bistim2 module will be used to administer active rTMS. Participants assigned to the active rTMS group will receive a total of 1.8 seconds of stimulation. Active rTMS will be administered 2 times daily with the following weekly schedule: 2 days of rTMS, 1 day of rest, 2 days of rTMS, 2 days of rest.
Group II: Placebo rTMSPlacebo Group1 Intervention
The intervention consists of 30 placebo rTMS sessions. Each session is comprised of 300 paired-pulse trains with the following parameters: 100µs paired pulses separated by 100ms inter-pulse-intervals and a five second inter-train-interval. Placebo rTMS sessions will be provided two times per day with a 70mm figure-of-eight coil over the left DLPFC. Two Magstim-2002 units and a Bistim2 module will be used to administer placebo rTMS. The placebo coil simulates magnetic stimulation, but does not actually emit a pulse. Participants assigned to the placebo rTMS group will receive 0 seconds of stimulation. Placebo rTMS will be administered with the following weekly schedule: 2 days of rTMS, 1 day of rest, 2 days of rTMS, 2 days of rest.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rTMS
2016
Completed Phase 3
~840
Find a Location
Who is running the clinical trial?
Edward Hines Jr. VA HospitalLead Sponsor
14 Previous Clinical Trials
1,724 Total Patients Enrolled
Northwestern UniversityOTHER
1,591 Previous Clinical Trials
917,594 Total Patients Enrolled
Theresa Pape, DrPH, MAPrincipal Investigator - Edward Hines Jr. VA Hospital
Edward Hines Jr. VA Hospital
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