The Research Process
Deciding whether or not to participate in research is a big decision. Always remember, participation in research in voluntary. That means you can change your mind at any time!
- The main goal is to better understand brain connections, thought processes, and symptoms in veterans with both PTSD and depression.
- Everyone who participates in this study will complete baseline assessments, which include: interviews, surveys, MRand computer based thinking tasks. Afterwards everyone will undergo an MRI brain scan.
- There are 4 groups of participants, where 1 groups with undergo infusions and 3 groups will not. We won't know whether you qualify for the infusions or not until after you complete the baseline assessments.
- Participants with PTSD+MDD will undergo a series of baseline assessments including a baseline functional magnetic resonance imaging (fMRI) then be randomized to receive either 6 ketamine or 6 normal saline infusions on a Monday-Friday schedule over 3 weeks. On the day of infusion, participants will be required to stay at the clinical site for 2 hours after the infusion has been given. They will also be monitored via a phone call on the following day. After the infusion period has been completed participants will undergo a follow-up fMRI then 4 follow-up visits, up to 2 months.
- Additional participants will be enrolled in healthy control, depression only, and PTSD only groups and will only undergo baseline assessments, including a single fMRI.
- The baseline assessments take about 4 hours to complete and may be split into two 2 hours visits and the MRI brain scan will be a separate visit and will last around 2 hours. All visits take place at the Minneapolis VA except for the MRI scan, which takes place at the University of Minnesota Center for Magnetic Resonance Research.
We are looking for veterans of any era or military background between the ages of 18-75 years old to participate.
- The goal of this study is to see if TBS can be used to reduce chronic post-traumatic headaches.
- TMS is a non-invasive FDA- approved treatment to treat depression and a specific kind of migraine headache and is used as an investigational treatment for other disorders such as chronic pain, stroke, and substance use.
- Theta Burst Stimulation, or TBS, is a form of TMS which uses a short patterned stimulation. During a stimulation session, you sit in a comfortable chair and a coil is place near your forehead over an area of the brain called the prefrontal cortex.
- The prefrontal cortex is a part of the brain involved in thought, mood, and pain regulation. The coil delivers magnetic pulses that create a small amount of electricity and increase the activity of nerve cells in the prefrontal cortex. After repeated stimulation sessions, the increased activity can alter the way the brain communicates with itself by strengthening or creating new neural pathways.
- Participants will complete four weeks of pre-intervention headache assessment via Ecological Momentary Assessment (EMA). Participants will then receive TBS intervention three times a week for four weeks. TBS will be administered in 10-minute sessions, three times per day with 20 minutes between sessions. TBS intervention will be completed using the Magstim Horizon Performance Transcranial Magnetic Stimulation (Magstim Company, Ltd.) device or the MagVenture MagPro X100 with MagOption Transcranial Magnetic Stimulation device (MagVenture, Inc.). Both devices are FDA-cleared to provide TBS for the treatment of Major Depressive Disorder and will be used off-label for this study.
We are looking for veterans between the ages of 18-75 years old, who suffer from a traumatic brain injury and post-traumatic headaches.