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Brain Stimulation for Concussion

Primary Purpose

Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Neuropsychological Tests

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure)
Sponsored by
The Mind Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Neuropsychological Tests, Traumatic Brain Injury, Post-Concussion Syndrome, TMS, Theta-burst, Diffusion magnetic resonance spectroscopy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult age at inclusion 18-64 years. mTBI as defined by an altered mental status at time of injury, and LOC of max 30 min, GCS 13-15 (after 30 min), and PTA max 24 hrs. Persistent post-traumatic symptoms in chronic phase (>3 months post-injury). Exclusion Criteria: History of developmental, neurological (e.g., epilepsy) or serious mental health disorders (e.g., schizophrenia, bipolar disorder) prior to TBI onset. History of a previous substance use disorder except for alcohol, or a currently active substance use disorder (within last 6 months.) Contraindications for MRI (e.g., any implanted ferromagnetic materials, claustrophobia, pregnancy) or iTBS (e.g., history of seizures).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Waitlist-control-treatment-group

    Arm Description

    After a 2-week control waitlist period, patient receive 30 treatments.

    Outcomes

    Primary Outcome Measures

    Post-concussive symptoms
    Rivermead post concussion symptoms questionnaire (16 items, rated 0-4, higher number indicating more symptoms, max score of 64; decrease of the score means improvement of symptoms)
    Neurometabolite diffusion related to neuronal function and inflammation
    As measured with diffusion MRS (diffusion of neurometabolites computed as the apparent diffusion coefficient (ADC)).

    Secondary Outcome Measures

    Cognitive functioning
    Neuropsychological test scores (attention measured using Stroop interference test: T scores, 0-100, higher scores indicating better performance; processing speed measured using the Symbol search test, also T-scores). Increase in score means clinical improvement.
    Functional outcome
    Glasgow Outcome Scale Extended (range 1-8, 1=dead, 8=complete recovery; increase in score means clinical improvement).
    Brain network functioning
    As measured with advanced MRI (e.g., improvement on the multimodal attention task can be reflected by a change in percent signal change in the dorsolateral prefrontal cortices of the executive network, which can be either an increase or decrease).

    Full Information

    First Posted
    May 9, 2023
    Last Updated
    October 19, 2023
    Sponsor
    The Mind Research Network
    Collaborators
    University of New Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05889117
    Brief Title
    Brain Stimulation for Concussion
    Official Title
    Neurometabolic Effects of Theta-burst Treatment in Mild Traumatic Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Mind Research Network
    Collaborators
    University of New Mexico

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to test a new type of magnetic brain stimulation in patients with persistent post-concussive symptoms. Participants will undergo detailed MRI scans before and after 30 treatment sessions (of 3-10 minutes each). The main questions the study aims to answer are: Will this new type of treatment result in fewer symptoms and better daily functioning? What are the effects of this treatment on brain functioning?
    Detailed Description
    Repetitive transcranial magnetic stimulation (rTMS) seems a promising treatment option for patients with persistent post-concussive symptoms (PPCS). Traditional rTMS sessions are relatively long in duration and can be exhaustive for patients with PPCS. Intermittent theta-burst stimulation (iTBS) is a newer and more rapid form of rTMS, which only takes up to 10 minutes per session. However, little is known about the effects of iTBS in patients with PPCS. Furthermore, there is a pressing need for methods that reliably measure the effects of TMS treatments in-vivo. Using diffusion magnetic resonance spectroscopy (dMRS) changes in neural and glial cell morphology can be quantified, which makes it possible to disentangle neurometabolic changes related to neural injury and neuroinflammation, two key elements in the pathophysiology of mTBI. In the current study, 15 patients with chronic (>3 months after mTBI) PPCS will undergo a total of 30 iTBS sessions. After a baseline scan, patients will enter a 2-week control waitlist period. Following the waitlist control, a pre-treatment scan is acquired, followed by the stimulation sessions, and final post-treatment scan. The scanning protocol includes T1 and T2 imaging, dMRS, multi-shell diffusion MRI (dMRI), as well as a demanding executive function fMRI task, and resting-state fMRI (rs-fMRI). A comprehensive battery of clinical tests will be administered at all time points, which includes cognitive testing, self-report of symptoms and emotional distress. Long-term outcome is determined three months after start of the study. Specific study aims are: Aim 1: To determine the effects of a precision-medicine iTBS guided approach applied to the left dorsolateral prefrontal cortex (DLPFC) on clinical recovery in patients with PPCS relative to waitlist control. Aim 2: To determine the neurometabolic effects of iTBS in both the left and right DLPFC as measured with dMRS in patients with PPS, and to untangle differential effects on pathophysiological processes (e.g., neural plasticity vs. anti-inflammatory effects). Aim 3: To determine the relationship of these neurometabolic effects and the integrity of major frontoparietal white matter tracts (as measured with dMRI), as well as activation and functional connectivity of key large-scale cognitive and emotional networks (i.e., executive, default mode, and salience network), measured using task-based and resting-state fMRI.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Neuropsychological Tests, Traumatic Brain Injury, Post-Concussion Syndrome
    Keywords
    Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, Neuropsychological Tests, Traumatic Brain Injury, Post-Concussion Syndrome, TMS, Theta-burst, Diffusion magnetic resonance spectroscopy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single group waitlist-control
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Waitlist-control-treatment-group
    Arm Type
    Experimental
    Arm Description
    After a 2-week control waitlist period, patient receive 30 treatments.
    Intervention Type
    Device
    Intervention Name(s)
    Intermittent theta-burst treatment (iTBS) using MagPro Transcranial Magnetic Stimulator (manufacturer: Magventure)
    Other Intervention Name(s)
    transcranial magnetic stimulation (TMS)
    Intervention Description
    3-10 minute sessions of brain stimulation applied to the left dorsolateral prefrontal cortex, up to 10 sessions a day, 30 sessions in total, planned within 2 weeks.
    Primary Outcome Measure Information:
    Title
    Post-concussive symptoms
    Description
    Rivermead post concussion symptoms questionnaire (16 items, rated 0-4, higher number indicating more symptoms, max score of 64; decrease of the score means improvement of symptoms)
    Time Frame
    Post-treatment (after completion of all sessions, at ~4 weeks), and at 3 months after start of the study for the individual participant. Data will be reported at the conclusion of the study for all participants.
    Title
    Neurometabolite diffusion related to neuronal function and inflammation
    Description
    As measured with diffusion MRS (diffusion of neurometabolites computed as the apparent diffusion coefficient (ADC)).
    Time Frame
    Post-treatment for the individual participant (~4 weeks). Data will be reported at the conclusion of the study for all participants.
    Secondary Outcome Measure Information:
    Title
    Cognitive functioning
    Description
    Neuropsychological test scores (attention measured using Stroop interference test: T scores, 0-100, higher scores indicating better performance; processing speed measured using the Symbol search test, also T-scores). Increase in score means clinical improvement.
    Time Frame
    Post-treatment for the individual participant (~4 weeks). Data will be reported at the conclusion of the study for all participants.
    Title
    Functional outcome
    Description
    Glasgow Outcome Scale Extended (range 1-8, 1=dead, 8=complete recovery; increase in score means clinical improvement).
    Time Frame
    At 3 months after start of the study for the individual participant. Data will be reported at the conclusion of the study for all participants.
    Title
    Brain network functioning
    Description
    As measured with advanced MRI (e.g., improvement on the multimodal attention task can be reflected by a change in percent signal change in the dorsolateral prefrontal cortices of the executive network, which can be either an increase or decrease).
    Time Frame
    Post-treatment for the individual participant (~ 4 weeks). Data will be reported at the conclusion of the study for all participants.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult age at inclusion 18-64 years. mTBI as defined by an altered mental status at time of injury, and LOC of max 30 min, GCS 13-15 (after 30 min), and PTA max 24 hrs. Persistent post-traumatic symptoms in chronic phase (>3 months post-injury). Exclusion Criteria: History of developmental, neurological (e.g., epilepsy) or serious mental health disorders (e.g., schizophrenia, bipolar disorder) prior to TBI onset. History of a previous substance use disorder except for alcohol, or a currently active substance use disorder (within last 6 months.) Contraindications for MRI (e.g., any implanted ferromagnetic materials, claustrophobia, pregnancy) or iTBS (e.g., history of seizures).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jody Roberts, MS
    Phone
    505-272-5028
    Email
    jroberts@mrn.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Harm J van der Horn, MD PhD
    Organizational Affiliation
    Mind Research Network
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Demographic, clinical, structural MRI, functional MRI, diffusion MRI, and diffusion MRS data will de-identified, linked to a global unique identifier (GUID) and uploaded to The Federal Interagency Traumatic Brain Injury Research (FITBIR) system. These data will be collected on 15 patients with mild traumatic brain injury. All data are exported in industry-specific, but standardized, formats to promote future research endeavors based on FAIR (Findable, Accessible, Interoperable, and Reusable) Data Principles.

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    Brain Stimulation for Concussion

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