Pilot TMS in Mild TBI

N/AEnrolling By InvitationNCT06999304

HealthPartners Institute20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Persistent Post Concussive Headache Mild Traumatic Brain Injury

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: baseline

Distribution of complaints for PPCS

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

Time frame: baseline

Mapping of complaints to anomalous parcellations

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

Time frame: baseline

Secondary Outcomes

Feasibility - rate of completed treatment

Percent of participants who complete 4 out of the 5 treatment visits.

Time frame: 4 weeks

Fidelity

Percent of participants who complete all sessions of treatment.

Time frame: 4 weeks

Safety - adverse events

Frequency of each adverse events.

Time frame: 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.

Time frame: 4 weeks

Pilot TMS in Mild TBI

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes