Treatment Study of Personalized Augmented Cognitive Training with Intermittent Theta Burst Stimulation for Depression After Mild Traumatic Brain Injury in Adults

What this Trial Is About

Researchers are evaluating whether combining Personalized Augmented Cognitive Training PACT with intermittent theta burst stimulation iTBS can help treat depression in adults who have experienced a mild traumatic brain injury mTBI. This study involves Service Members, Veterans, and civilians and aims to compare the effects of PACT plus iTBS against PACT plus a sham placebo iTBS treatment. The goal is to see if the active combination leads to greater improvements in depression over an 8-week period. Participants receive six sessions of PACT over four weeks and twenty sessions of either real iTBS or sham iTBS applied to the left dorsolateral prefrontal cortex during the same time frame. The study groups are randomized, and both participants and researchers are blinded to which treatment is given. The study uses a device to deliver iTBS, and the sham group receives a simulated version to help measure the treatment effect. During the study, participants undergo assessments at the start, two weeks, four weeks, and eight weeks. These include depression rating scales, questionnaires on symptoms like PTSD and headaches, cognitive function tests, and quality of life measures. Safety screenings for MRI and TMS compatibility are conducted, and participants must be able to follow the treatment schedule and complete all procedures in English. The main outcome is the change in depression severity after 8 weeks, tracked using the Hamilton Rating Scale for Depression.

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression