Mild Traumatic Brain Injury, Persistent Post Concussive Headache
Conditions
Keywords
transmagnetic stimulation, functional MRI guided theta burst stimulation, intermittent theta burst stimulation
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.
Interventions
DEVICEIntermittent 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
Sponsors
HealthPartners Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with anomalous parcellations - developing the method of personalization of TMS for PPCS | baseline | 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. |
| Anomalous parcellations - developing the method of personalization of TMS targets for PPCS | baseline | Names and number of anomalous parcellations identified using connectivity analysis and targets available to treat with TMS based on symptom profiles |
| Distribution of complaints for PPCS | baseline | Distribution of chief symptom/complaints among participants measured by concussion clinical profile (CP) screen |
| Mapping of complaints to anomalous parcellations | baseline | Mapping of chief symptom/complaints to parcellations based on literature and connective abnormalities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - rate of completed treatment | 4 weeks | Percent of participants who complete 4 out of the 5 treatment visits. |
| Fidelity | 4 weeks | Percent of participants who complete all sessions of treatment. |
| Safety - adverse events | 16 weeks | Frequency of each adverse events. |
| Acceptability | 4 weeks | This survey will be used to understand the subject's experience with TMS and whether they feel it is an acceptable form of treatment. Questions will be both open-ended and quantitative (Likert scale). In this study, participants will be asked about their level of satisfaction with various aspects of the treatment. This survey is not standardized. Scores presented as percent of subject responses. Range: \[0-100\]. Higher percentage indicates more acceptability to this form of treatment. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBhavani Kashyap, MBBS, PhD
HealthPartners Institute
Outcome results
None listed