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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - rate of completed treatment | Percent of participants who complete 4 out of the 5 treatment visits. | 4 weeks |
| Fidelity | Percent of participants who complete all sessions of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Explore pre-post changes concurrent with personalized TMS on PPCS - global post-concussion scale | Pre-post change in global post-concussion scale - Rivermead Post-Concussion Symptoms Questionnaire (RPQ) from baseline to 4- and 12-weeks post-enrollment. The RPQ consists of 16 questions about symptoms experienced after a head injury, rated on a scale of 0-4. Range [0-64]. A higher score indicates more severe symptoms. A positive change from pre to post (post score-pre score=change) indicates that symptoms get worse. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bhavani Kashyap, MBBS, PhD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
No identifiable data will be shared with other researchers.
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
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| 4 weeks |
| Safety - adverse events | Frequency of each adverse events. | 16 weeks |
| Acceptability | 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. | 4 weeks |
| 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 | Pre-post change in symptom specific profile scale (general anxiety disorder-7 (GAD7)) from baseline to 4- and 12-weeks post-enrollment. The GAD7 is a 7-item anxiety scale that is self-administered, valid, and an efficient tool for screening for GAD and assessing its severity in clinical practice and research. Range: [0-21] A higher score indicates more anxiety. A positive change from pre to post (post score-pre score=change) indicates that anxiety symptoms get worse. | 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 | Pre-post change in symptom specific profile scale (speed of forgetting (SoF)) from baseline to 4- and 12-weeks post-enrollment. The SOF quantifies the rate of episodic trace decay without the effects of learning. Content is presented as cue-pair associates and assessed through multiple-choice or verbal recall questions. This test is 8 minutes long. Range: [0-1]. A higher score indicates more memory impairment. A positive change from pre to post (post score-pre score=change) indicates that memory gets worse. | baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment |
| Explore pre-post changes concurrent with personalized TMS on PPCS - CP screen | Pre-post change in Concussion Clinical Profiles Screening (CP) from baseline to 4- and 12-weeks post-enrollment. The CP is a 29 item self report tool to assess clinical profiles associated with concussion. Range: [0-87]. A higher score indicates more severe symptoms. A positive change from pre to post (post score-pre score=change) indicates that symptoms get worse. | baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment |
| Explore pre-post changes concurrent with personalized TMS on PPCS - respond to treatment | Percent of participants that respond to treatment based on improvement in symptom specific scales at 1- 4- and 12-weeks post-enrollment, defined as either show minimally clinically important difference (MCID) ≥2 SD improvement from baseline at a given timepoint | baseline, 1 week post-treatment, 4 week post-treatment, 12 week post-treatment |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |