Pilot TMS in Mild TBI

Launched by HEALTHPARTNERS INSTITUTE · May 22, 2025

Keywords

ClinConnect Summary

This is a small, early-stage study testing a personalized brain-stimulation approach to help people who have persistent symptoms after a mild traumatic brain injury (concussion). The researchers use a noninvasive technique called theta burst stimulation (a fast sequence of magnetic pulses) guided by each person’s brain MRI to target brain areas most tied to their symptoms. The goal is to see if matching stimulation targets to a person’s symptom profile is feasible and safe, and to learn how symptoms progress with treatment. The study will enroll about 20 adults aged 18 to 65 who had a mild brain injury 4 weeks to 12 months ago and have significant post-concussion symptoms (a PCSS score of 35 or higher).

Participants will receive 25 stimulation sessions over about two weeks, spread across five treatment visits. The treatment is done with a device placed on the head and targets two brain regions: a standard left-side area and a personalized region chosen from imaging and symptoms. The study will look at safety and acceptability, as well as changes in symptoms such as post-concussion symptoms, anxiety, and memory, with follow-up assessments up to 12 weeks after enrollment. This is a research protocol conducted at HealthPartners Institute in Saint Paul, Minnesota, and results are not available yet. Identifiable data will not be shared outside the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinical diagnosis of mTBI at least 4 weeks prior but not exceeding 12 months prior to the time of screening
• • 2. Age 18-65 years at the time of mTBI
• • 3. High burden of post concussive symptoms at time of screening, as measured by symptoms questionnaire (PCSS) ≥35\*
• Exclusion Criteria:
• • 1. Inability to tolerate imaging; contraindication of imaging due to implants or metal
• • 2. Seizure disorder, active alcohol or substance use disorder
• • 3. Inability to speak and read English
• • 4. Anything else that, in the opinion of the PI/study physician, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
• • 5. Subject is pregnant or breast feeding
• • 6. Subject has participated in a clinical interventional trial in the last 3 months