Clinical trial NCT06999304: Pilot TMS in Mild TBI
Official title: Personalized Accelerated Theta Burst Transcardial Magnetic Stimulation in Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Persistent Post Concussive Headache
Mild Traumatic Brain Injury
Keywords: transmagnetic stimulation
functional MRI guided theta burst stimulation
intermittent theta burst stimulation
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS
timeFrame: baseline
measure: Anomalous parcellations - developing the method of personalization of TMS targets for PPCS
timeFrame: baseline
measure: Distribution of complaints for PPCS
timeFrame: baseline
measure: Mapping of complaints to anomalous parcellations
timeFrame: baseline
Secondary outcomes:
measure: Feasibility - rate of completed treatment
timeFrame: 4 weeks
measure: Fidelity
timeFrame: 4 weeks
measure: Safety - adverse events
timeFrame: 16 weeks
measure: Acceptability
timeFrame: 4 weeks
Other outcomes:
measure: Explore pre-post changes concurrent with personalized TMS on PPCS - global post-concussion scale
timeFrame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
measure: Explore pre-post changes concurrent with personalized TMS on PPCS - generalized anxiety
timeFrame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
measure: Explore pre-post changes concurrent with personalized TMS on PPCS - speed of forgetting
timeFrame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
measure: Explore pre-post changes concurrent with personalized TMS on PPCS - CP screen
timeFrame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
measure: Explore pre-post changes concurrent with personalized TMS on PPCS - respond to treatment
timeFrame: baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Bhavani Kashyap, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: