Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury (The CONNECT-TBI Trial)
Abstract
Rationale: Mild traumatic brain injury (mTBI) is the most common injury of our returning Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn Service members and Veterans. Although most patients with mTBI will experience full recovery within three months, a great number will still have significant ongoing difficulty with their memory, attention, and planning. Only recently have scientists been able to detect how the brain is functioning abnormally after an mTBI; our group of scientists has found evidence that the brain is less efficient after an mTBI and has a harder time doing normal things. Unfortunately, the treatment methods we have available only result in mild benefit and require significant time and resources. We think that a very promising treatment for mTBI is brain stimulation: using gentle electricity and magnetic fields to help the brain function more normally. Therefore, we propose a clinical trial called CONNECT-TBI. Objectives: CONNECT-TBI will investigate whether training can be boosted for Veterans with mTBI and cognitive problems. We plan to combine two types of brain stimulation, repetitive transcranial magnetic stimulation (rTMS), and high-definition transcranial direct current stimulation (HD-tDCS) with standard cognitive training. Both of these brain stimulation methods generate electrical currents in the brain and cause brain regions to behave and interact differently. It is our hypothesis that they will improve attention and planning abilities, reduce symptoms from mTBI, and improve quality of life. We will use brain scans to tell us where to place the stimulators on each person’s head, so that they are sending electrical currents to the places that are most important for attention. Study Design: We plan to recruit 108 Veterans with mTBI and problems with attention for the study. We will first gather information about their background, their performance on tests of attention, mTBI symptoms, and quality of life. Then all participants will undergo magnetic resonance imaging (MRI) to provide a detailed picture of the brain while it is paying attention as well as during rest. This will indicate where exactly malfunctions are occurring. Next, the participants will all receive Attention Process Training, a type of rehabilitation program, four times a week, for 4 weeks. While they are doing the training, they will receive HD-tDCS, rTMS, or sham (no real stimulation). After the stimulation sessions are completed, we will gather the same information and scans as before to see what the different stimulation types had on these tests. Applicability/Impact of the Clinical Trial: Type of patients helped, how it will help them: Our study is focused on military personnel with cognitive symptoms from mTBI. In order to make our results as widely applicable to military populations, we will recruit Veterans from two different cities, Minneapolis, MN, and Albuquerque, NM. We expect that the two types of brain stimulation will both be able to reduce cognitive symptoms PCS and will also improve function and quality of life. We also expect that, after active brain stimulation, brain activity on MRI will look more like normal, indicating that the brain is becoming more efficient. Potential Clinical Applications, Benefits, Risks: If successful, this study will show that a new treatment for cognitive problems after mTBI exists that has the potential to profoundly change the approach to mTBI. This would be of great benefit to the military as well as the civilian population, given the large numbers of mTBIs that occur yearly, the controversy regarding the mechanisms of symptoms, and how little research exists investigating effective treatments. Brain stimulation generates only weak electrical currents that cause mild sensations, and it does not involve anesthesia or convulsions. It is safe, portable, and well-tolerated, making it useful as a treatment in any setting, including
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010928
Entities
People
- Davin Quinn
Organizations
- Health Sciences Center, University of New Mexico
- United States Army