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Theta Burst Stimulation for Headaches After Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT04906603
Recruitment Status : Recruiting
First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Collaborators:
Minnesota Office of Higher Education
The Defense and Veterans Brain Injury Center
Information provided by (Responsible Party):
Cristina Sophia Albott, Minneapolis Veterans Affairs Medical Center

Brief Summary:
The purpose of this study is to evaluate if theta burst stimulation (TBS) can reduce chronic headaches caused by a traumatic brain injury (TBI). TBS is a safe, drug-free brain stimulation technique that uses magnets to create electricity and stimulate nerve cells in the brain. After repeated TBS sessions, the increased stimulation of nerve cells can alter the way the brain communicates with itself (by creating new neural pathways) which, in turn, can reduce pain symptoms. Participants in this study will complete a baseline assessment followed by four weeks of daily home headache assessment. Participants will then receive four weeks of TBS administered three times per day and three days per week. After TBS is completed, participants will complete an additional four weeks of daily home headache assessment and return for a one-month follow-up assessment. Participation is expected to last three months.

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Transcranial Magnetic Stimulation Brain Injuries, Traumatic Quality of Life Device: Theta Burst Stimulation Not Applicable

Detailed Description:

The primary objective of this study is to investigate the safety and efficacy of theta burst stimulation (TBS) for the management of post-traumatic headaches to improve outcomes and quality of life for individuals who have suffered a traumatic brain injury (TBI). To improve tolerability and logistical burden, we have developed a novel design whereby participants will receive three doses of TBS on alternate days of the week. This design will allow us to assess efficacy while leveraging an accelerated treatment course (nine stimulation sessions per week). We have three specific aims:

Specific Aim 1. To determine the efficacy and safety of TBS for the treatment of post-traumatic headache among individuals who have sustained a mild TBI. Hypothesis 1a: TBS will be safe, well-tolerated, and reduce the number of headache days. Hypothesis 1b: TBS will improve function and quality of life outcomes.

Specific Aim 2: To determine the efficacy and safety of an accelerated time-course of TBS for the management of post-traumatic headache. Hypothesis 2a: The accelerated-time course will be safe, well-tolerated, and improve quality of life outcomes. Hypothesis 2b: The accelerated time-course will produce greater and faster improvement in headache symptoms than that reported in the literature for standard repetitive transcranial magnetic stimulation (rTMS) protocols.

Specific Aim 3: To examine the durability of treatment response to accelerated TBS during a one-month observational period. Hypothesis 3: Accelerated TBS will result in enduring treatment response of post-traumatic headache symptoms over the follow-up period.

This study will be an open-label pilot study and will enroll 20. Participants will complete four weeks of pre-intervention headache assessment via Ecological Momentary Assessment (EMA). Participants will then receive TBS intervention three times a week for four weeks. TBS will be administered in 10-minute sessions, three times per day with 20 minutes between sessions. TBS intervention will be completed using the Magstim Horizon Performance Transcranial Magnetic Stimulation (Magstim Company, Ltd.) device or the MagVenture MagPro X100 with MagOption Transcranial Magnetic Stimulation device (MagVenture, Inc.). Both devices are FDA-cleared to provide TBS for the treatment of Major Depressive Disorder and will be used off-label for this study. After TBS intervention, participants will complete an additional four weeks of EMA headache assessment and return for a one-month follow-up assessment. Participants will be assessed with multiple instruments and at multiple timepoints including interviews, questionnaires, and cognitive functioning assessments.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Theta Burst Stimulation for Headaches After Traumatic Brain Injury
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TBS Headache Device: Theta Burst Stimulation
TBS will be administered three times per day and three days per week for four weeks (totaling 12 TBS intervention visits and 36 TBS intervention sessions). Each TBS intervention session will last approximately 10 minutes (stimulation parameters = 50 Hz, 3 pulses, 10 bursts, 10 second cycle time, 60 cycles, 1800 total pulses).




Primary Outcome Measures :
  1. Ecological Momentary Assessment (EMA) for Headache Frequency, Intensity, and Impairment [ Time Frame: Participants will take the daily headache assessment every day for 2 weeks pre-intervention, every day for 4 weeks during intervention, and every day for 4 weeks post-intervention to track their change in headache frequency, intensity, and impairment. ]
    EMA will be used for repeated real-time sampling of headaches symptoms prior to intervention, during intervention, and after intervention. Participants will access the EMA application (app) on their personal smartphones.

  2. World Health Organization Quality of Life Scale (WHOQOL-BREF) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]
    The WHOQOL-BREF is a 26-item self-report assessment of quality of life and will be used to assess changes in QOL over the course of the study. Items are rated on a scale from 1 (very poor) to 5 (very good).

  3. Migraine Disability Assessment (MIDAS) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]
    The MIDAS is a 5-item self-report assessment of headache disability and will be used to assess change in headache impairment over the course of the study. Participants are to respond with the number of days they have experienced various types of headache disability. The last question asks them to rate on a scale from 0 (no pain at all) to 10 (pain as bad as it can be).

  4. Patient-Reported Outcomes Measurement Information System - Pain Interference - Short Form 6b (PROMIS-SF6b) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]
    The PROMIS-SF6b is a 6-item self-report assessment of pain interference and will be used to assess change in universal (non-headache specific) pain over the course of the study. Items are rated on a 5 point scale from "Not at all" to "Very Much".


Secondary Outcome Measures :
  1. Barratt Impulsiveness Scale - Version 11 (BIS-11) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]
    The BIS-11 is a 30-item self-report measure of impulsivity and will be used to assess change in impulsive behavior over the course of the study. Items are rated on a 4 point scale from "Rarely or never" to "Almost always or always".

  2. Beck Anxiety Inventory (BAI) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]
    The BAI is a 21-item self report assessment of anxiety severity and will be used to assess change in mood over the course of the study. Items are rated on a 4 point scale from "Not at all" to "Severely---it bothered me a lot."

  3. Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]

    The QIDS-SR is a 16-item self-report assessment of depression severity and will be used to assess change in mood over the course of the study. Each item has 4 choices that specifically tie in to the question. For example:

    Question 1. Falling asleep

    1. I never take longer than 30 minutes to fall asleep
    2. I take at least 30 minutes to fall asleep, less than half the time.
    3. I take at least 30 minutes to fall asleep, more than half the time.
    4. I take more than 60 minutes to fall asleep, more than half the time.

  4. PTSD Checklist for DSM-V (PCL-5) [ Time Frame: Baseline visit, pre-intervention (2 weeks after baseline), post-intervention (4 weeks after pre-intervention), and at follow-up (1 month post-intervention). ]
    The PCL-5 is a 20-item self-report measure of post-traumatic stress disorder (PTSD) symptoms and severity and will be used to assess change in mood over the course of the study. Items are rated on a 5 point scale from "Not at all" to "Extremely".

  5. Dot Counting (Cognitive Task) [ Time Frame: The dot counting task will be administered at every stimulation visit during the 4 weeks of intervention (total of 12 times). ]
    The Dot Counting Task is a computerized measure of verbal working memory.

  6. N-Back (Cognitive Task) [ Time Frame: The N-Back task will be administered at every stimulation visit during the 4 weeks of intervention (a total of 12 times). ]
    The N-Back Task is a continuous performance test that is used to measure working memory and processing speed.

  7. Risk Task (Cognitive Task) [ Time Frame: The risk task will be administered at every stimulation visit during the 4 weeks of intervention ( a total of 12 times). ]
    The Risk Task is a computerized behavioral measure of the propensity for risk taking within a decision making task.

  8. Caffeine and Nicotine Use Questionnaire [ Time Frame: Baseline and daily for 10 weeks after baseline ]
    The Caffeine and Nicotine Use Questionnaire is a proprietary measure used to record typical patterns of caffeine and nicotine use at study baseline. Daily caffeine and nicotine use will then be tracked over the course of the study using EMA.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans receiving services through the MVAHCS
  • History of mild TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:

    • Loss of consciousness between 0-30 minutes
    • Post-traumatic amnesia between 0-24 hours
    • Alteration of consciousness/mental state up to 24 hours
    • Glasgow Coma Score between 13-15 (best available score within first 24 hours)
  • Post-traumatic headaches defined by International Classification for Headache Diagnosis 3rd Edition (ICHD-3) guidelines with the following criteria present:

    • Headaches developing within seven days following trauma or injury to the head and/or neck
    • Headaches persisting beyond three months
  • Chronic daily headaches defined by clinical standards with the following criterion present:

    o 15 or more headache days per month

  • Men and women 18-75 years of age
  • Possess a smartphone and agree to download and use the EMA application on their personal device
  • Capable and willing to provide voluntary informed consent

Exclusion Criteria:

  • History of moderate or severe TBI according to VA/DoD Clinical Practice Guidelines (2009) with one or more of the following criteria present after head injury:

    • Loss of consciousness greater than 30 minutes
    • Post-traumatic amnesia greater than 24 hours
    • Worst Glasgow Coma Scale less than 13 within the first 24 hours unless invalidated upon review (e.g., attributable to intoxication, sedation, systemic shock)
    • Abnormal structural imaging
  • Current (within six months of enrollment) psychosis and mania
  • Current (within one month of enrollment) substance dependence with the exclusion of opioids
  • Personal history of epilepsy or seizure disorder

    o Does not include seizures therapeutically-induced by ECT or identified as a single seizure event (based on the principal investigator's judgement)

  • Metal particles in the eye or head (exclusive of the mouth) (e.g., shrapnel, fragments from welding or metalwork, etc.)
  • Implanted medical device above the clavicle (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes, etc.)
  • Significant neurological disorder or insult that would impact risk (based on the principal investigator's judgement and research literature)
  • Current use of medications with significant potential for lowering seizure threshold
  • Current benzodiazepine usage at a dose higher than 3mg of lorazepam or equivalent
  • Electroconvulsive therapy (ECT) or cortical energy exposure within one month of enrollment (including participation in any other neuromodulation treatments or studies)
  • Current (within one month of enrollment) participation in another interventional study that would impact the results of this research
  • Inadequate communication (e.g., language barrier)
  • Women who are pregnant, trying to become pregnant, or breastfeeding
  • Women of childbearing age/potential who are not using a medically-accepted form of contraception when sexually active

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04906603


Contacts
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Contact: Katrina Friedrich 612-467-1811 katrina.friedrich@va.gov
Contact: Alyssa Krueger 612-467-1829 Alyssa.Krueger@va.gov

Locations
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United States, Minnesota
Minneapolis VA Health Care System Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Katrina Friedrich    612-467-1811    Katrina.Friedrich@va.gov   
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Minnesota Office of Higher Education
The Defense and Veterans Brain Injury Center
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Responsible Party: Cristina Sophia Albott, Physician, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT04906603    
Other Study ID Numbers: VAM-19-00458
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Final data sets may be made available upon written request and subject to sponsor approval.

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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
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Post-Traumatic Headache
Headache
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders