Pilot TMS in Mild TBI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittent theta burst stimulation.
- Who it may be relevant to
- Registry conditions: Persistent Post Concussive Headache, Mild Traumatic Brain Injury. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Personalized Accelerated Theta Burst Transcardial Magnetic Stimulation in Mild Traumatic Brain Injury
Overview
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.
Interventions
- Device 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
Primary outcome measures
- Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS [Time frame: baseline]
- Anomalous parcellations - developing the method of personalization of TMS targets for PPCS [Time frame: baseline]
- Distribution of complaints for PPCS [Time frame: baseline]
- Mapping of complaints to anomalous parcellations [Time frame: baseline]
Secondary outcome measures (4)
- Feasibility - rate of completed treatment [Time frame: 4 weeks]
- Fidelity [Time frame: 4 weeks]
- Safety - adverse events [Time frame: 16 weeks]
- Acceptability [Time frame: 4 weeks]
Eligibility criteria
Inclusion criteria
- 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\*
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- HealthPartners Neuroscience Center — Saint Paul
Identifiers
NCT: NCT06999304 · A24-141