Pilot TMS in Mild TBI

NCT06999304 | Enrolling By Invitation FDA Device

• 1 other identifier: A24-141
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

transmagnetic stimulation; functional MRI guided theta burst stimulation; intermittent theta burst stimulation

Outcome Measures

Primary Outcomes (4)

• Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS

  Percentage of participants matched with anomalous parcellations based on one of the 2 top ranked burdensome symptoms/symptom profile. If an anomalous parcellation matching one of the top 2 ranked symptom profiles can be identified in at least 16 out of 20 (80%) of participants, the trial will be considered a success.

  baseline

• Anomalous parcellations - developing the method of personalization of TMS targets for PPCS

  Names and number of anomalous parcellations identified using connectivity analysis and targets available to treat with TMS based on symptom profiles

  baseline

• Distribution of complaints for PPCS

  Distribution of chief symptom/complaints among participants measured by concussion clinical profile (CP) screen

  baseline

• Mapping of complaints to anomalous parcellations

  Mapping of chief symptom/complaints to parcellations based on literature and connective abnormalities

  baseline

Secondary Outcomes (4)

• Feasibility - rate of completed treatment

  4 weeks

• Fidelity

  4 weeks

• Safety - adverse events

  16 weeks

• Acceptability

  4 weeks

Other Outcomes (5)

• Explore pre-post changes concurrent with personalized TMS on PPCS - global post-concussion scale

  baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment

• Explore pre-post changes concurrent with personalized TMS on PPCS - generalized anxiety

  baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment

• Explore pre-post changes concurrent with personalized TMS on PPCS - speed of forgetting

  baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment

Study Arms (1)

Theta burst stimulation

EXPERIMENTAL

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.

Device: Intermittent theta burst stimulation

Interventions

Intermittent theta burst stimulation 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

Also known as: Transmagnetic stimulation, MagVenture

Theta burst stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of mTBI at least 4 weeks prior but not exceeding 12 months prior to the time of screening
• Age 18-65 years at the time of mTBI
• High burden of post concussive symptoms at time of screening, as measured by symptoms questionnaire (PCSS) ≥35\*

You may not qualify if:

• Inability to tolerate imaging; contraindication of imaging due to implants or metal
• Seizure disorder, active alcohol or substance use disorder
• Inability to speak and read English
• 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.
• Subject is pregnant or breast feeding
• Subject has participated in a clinical interventional trial in the last 3 months

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Bhavani Kashyap, MBBS, PhD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 31, 2025
• Study Start: June 18, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)