Pilot TMS in Mild TBI

NCT ID: NCT06999304

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-18
• Study Completion Date: 2027-07-31

Brief Summary

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.

Conditions

Persistent Post Concussive Headache; Mild Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Theta burst stimulation

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.

Group Type: EXPERIMENTAL

Intermittent theta burst stimulation

Intervention Type: DEVICE

MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Intermittent theta burst - Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz; Continuous theta burst - Number of pulses per session: 1800 pulses; Pulse frequency in burst: 50 Hertz

Interventions

Intermittent theta burst stimulation

MagVenture TMS Therapy active coil with theta burst stimulation. Resting motor threshold: 80%; Intermittent theta burst - Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz; Continuous theta burst - Number of pulses per session: 1800 pulses; Pulse frequency in burst: 50 Hertz

Intervention Type: DEVICE

Other Intervention Names

Transmagnetic stimulation; MagVenture

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bhavani Kashyap, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

A24-141

Identifier Type: -

Identifier Source: org_study_id