Pilot TMS in Mild TBI

HealthPartners Institute

Status: Invitation-only

Conditions: Mild Traumatic Brain Injury; Persistent Post Concussive Headache

Treatments: Device: Intermittent theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06999304

A24-141

Details and patient eligibility

About

Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS; however, the current one-size-fits-all approach does not address the heterogeneity of symptoms. We propose utilization of resting state functional MRI (rs-fMRI) guided rTMS to target personalized brain networks burdened with PPCS.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Theta burst stimulation

Experimental group

Description:

There will be a total of 25 theta burst sessions across 5 treatment visits (5 sessions per treatment visit), over a two-week period. Treatment will be applied to 2 brain regions of interest or parcellations: (1) Left 8AV; 2) A personalized region based on imaging and symptom profile.

Treatment:

Device: Intermittent theta burst stimulation