search
Back to results

Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome

Primary Purpose

Post Concussion Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent Theta-Burst Stimulation
Sham Intermittent Theta-Burst Stimulation
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Concussion Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Documented evidence of head trauma sufficiently severe to result in loss of consciousness, post-traumatic amnesia and/or acute altered mental status. At least three symptoms including headache, dizziness, fatigue, irritability, insomnia, memory difficulties, concentration difficulties, mood dysregulation. Onset of symptoms within 4 weeks following the head trauma. Age 18-60, inclusive. Persistence of PCS symptoms for at least 3 months but less than 12 months Able to provide informed consent and comply with the study protocol Patients will not be excluded solely on the basis of communication (i.e., non-English speaking) unless they have exclusion criteria that is the cause of the communication difficulties. Exclusion Criteria: Evidence of major structural neuroimaging abnormalities (e.g., intracranial hemorrhage, skull fracture or a large intracranial lesion) History of prior rTMS therapy, Contraindications to MRI (e.g., pacemaker, metallic implants etc.). Ferromagnetic, non-removable metallic implants from above the clavicle with the exception of dental work. Active personal injury litigation History of seizure disorder, not including febrile seizures in childhood Substance dependence within the last 6 months Pregnant Currently taking more than lorazepam 2 mg daily (or benzodiazepine equivalent) or any dose of an anticonvulsant (due to the potential to reduce rTMS efficacy) Currently taking an antiepileptic medication Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy) A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and/or psychosis at the time of study enrollment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Treatment

    Sham

    Arm Description

    Outcomes

    Primary Outcome Measures

    Rivermead Post Concussion Symptoms Questionnaire
    RPQ, a validated measure of subjective global PCS symptoms.
    Rivermead Post Concussion Symptoms Questionnaire
    RPQ, a validated measure of subjective global PCS symptoms.
    Rivermead Post Concussion Symptoms Questionnaire
    RPQ, a validated measure of subjective global PCS symptoms.

    Secondary Outcome Measures

    Montgomery-Åsberg Depression Rating Scale
    Montgomery-Åsberg Depression Rating Scale is a widely used clinician-rated measure of depressive severity
    Repeatable Battery for the Assessment of Neuropsychological Status
    RBANS is a brief, individually administered battery to measure cognitive decline or improvement
    The Behavior Rating Inventory of Executive Function
    BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
    Headache Impact Test
    HIT is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations.

    Full Information

    First Posted
    June 20, 2023
    Last Updated
    September 7, 2023
    Sponsor
    Sunnybrook Health Sciences Centre
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06031662
    Brief Title
    Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome
    Official Title
    Image-guided, Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sunnybrook Health Sciences Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    TMS has been safely and reliably delivered at the Harquail Centre for over 5 years, with a primary focus on conventional rTMS protocols for treatment-resistant depression. Recently, the investgator team has gained the capability to deliver sham-controlled intermittent theta-burst stimulation (iTBS) rTMS. Unlike conventional high frequency rTMS, which was used in the previous sham-controlled rTMS PCS pilot study, iTBS is a patterned form of stimulation that recapitulates endogenous activity patterns of neural circuits pairing gamma frequency (50Hz) burst pulses coupled in a theta frequency rhythm (5Hz).12 iTBS delivers 600 pulses in just over 3 minutes with similar or greater effects on neural plasticity compared to conventional rTMS (taking over 30-45 minutes) and similar tolerability and efficacy in trials of depression. Furthermore, novel accelerated iTBS protocols stimulating the left dorsolateral prefrontal cortex (dlPFC) over 8-10 treatments, 50 minutes apart over a 5 day interval has recently demonstrated robust efficacy in depression and received recent FDA approval. Thus, accelerated iTBS can be delivered in a single week of treatment compared to 6 weeks with conventional rTMS methods. Finally, the investigators recently acquired the technology to integrate MRI neuroimage-guided stimulation, which would allow to target specific brain regions/networks implicated in PCS at high spatial resolution. No studies to date have investigated image-guided accelerated iTBS rTMS for the treatment of PCS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Concussion Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    26 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Title
    Sham
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Intermittent Theta-Burst Stimulation
    Intervention Description
    Accelerated course of left dlPFC iTBS, consisting of 600 pulses/session, 50 minutes intersession interval, 8 session/day for 5 days) at 90% resting MT
    Intervention Type
    Device
    Intervention Name(s)
    Sham Intermittent Theta-Burst Stimulation
    Intervention Description
    Magventure Active/Placebo B70 coil specifically designed for randomized clinical trials with TMS. This system uses electrodes placed on the scalp to provide stimulation mimicking the active treatment condition
    Primary Outcome Measure Information:
    Title
    Rivermead Post Concussion Symptoms Questionnaire
    Description
    RPQ, a validated measure of subjective global PCS symptoms.
    Time Frame
    Baseline, change from baseline to immediately before the first iTBS treatment
    Title
    Rivermead Post Concussion Symptoms Questionnaire
    Description
    RPQ, a validated measure of subjective global PCS symptoms.
    Time Frame
    5 days
    Title
    Rivermead Post Concussion Symptoms Questionnaire
    Description
    RPQ, a validated measure of subjective global PCS symptoms.
    Time Frame
    1 month post-treatment
    Secondary Outcome Measure Information:
    Title
    Montgomery-Åsberg Depression Rating Scale
    Description
    Montgomery-Åsberg Depression Rating Scale is a widely used clinician-rated measure of depressive severity
    Time Frame
    Baseline, post treatment day 5, and post treatment 1 month
    Title
    Repeatable Battery for the Assessment of Neuropsychological Status
    Description
    RBANS is a brief, individually administered battery to measure cognitive decline or improvement
    Time Frame
    Baseline and post treatment 1 month
    Title
    The Behavior Rating Inventory of Executive Function
    Description
    BRIEF-A is a standardized measure that captures views of an adult's executive functions or self-regulation in his or her everyday environment.
    Time Frame
    Baseline, post treatment day 5, and post treatment 1 month
    Title
    Headache Impact Test
    Description
    HIT is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations.
    Time Frame
    Baseline and post treatment 1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented evidence of head trauma sufficiently severe to result in loss of consciousness, post-traumatic amnesia and/or acute altered mental status. At least three symptoms including headache, dizziness, fatigue, irritability, insomnia, memory difficulties, concentration difficulties, mood dysregulation. Onset of symptoms within 4 weeks following the head trauma. Age 18-60, inclusive. Persistence of PCS symptoms for at least 3 months but less than 12 months Able to provide informed consent and comply with the study protocol Patients will not be excluded solely on the basis of communication (i.e., non-English speaking) unless they have exclusion criteria that is the cause of the communication difficulties. Exclusion Criteria: Evidence of major structural neuroimaging abnormalities (e.g., intracranial hemorrhage, skull fracture or a large intracranial lesion) History of prior rTMS therapy, Contraindications to MRI (e.g., pacemaker, metallic implants etc.). Ferromagnetic, non-removable metallic implants from above the clavicle with the exception of dental work. Active personal injury litigation History of seizure disorder, not including febrile seizures in childhood Substance dependence within the last 6 months Pregnant Currently taking more than lorazepam 2 mg daily (or benzodiazepine equivalent) or any dose of an anticonvulsant (due to the potential to reduce rTMS efficacy) Currently taking an antiepileptic medication Mild and major comorbid medical conditions (as determined by investigators - e.g., neurological diseases, uncontrolled hypertension or diabetes, malignancy) A major comorbid psychiatric disorder (as determined by investigators - e.g., schizophrenia or bipolar disorder) and/or psychosis at the time of study enrollment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sean Nestor, PhD, MD, FRCPC
    Phone
    416-480-4085
    Email
    sean.nestor@sunnybrook.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matthew Burke, MD, FRCPC
    Phone
    416-480-4216
    Email
    matthew.burke@sunnybrook.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome

    We'll reach out to this number within 24 hrs