<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03007420</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00025021</org_study_id>
    <nct_id>NCT03007420</nct_id>
  </id_info>
  <brief_title>A Prospective Controlled Treatment Trial for Post-Traumatic Headaches</brief_title>
  <official_title>A Prospective Controlled Treatment Trial for Post-Traumatic Headaches</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury,&#xD;
      possibly generated by a number of stressors to the trigeminovascular and cervical plexus&#xD;
      networks, including inflammation of the high cervical facet joints, traumatic cranial&#xD;
      neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for&#xD;
      PTH management except for conservative modalities, such as cognitive rest, physical therapy,&#xD;
      and neuropathic pain medications, all of which have minimal evidence to support them.&#xD;
&#xD;
      The investigators propose a randomized, controlled, clinical trial and prospective follow-up&#xD;
      study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and&#xD;
      cervical medial branch block (CMBB) in the management of PTH.&#xD;
&#xD;
      Adolescents and adults (14-45 years of age) will be recruited from Boston Children's Hospital&#xD;
      and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache&#xD;
      clinics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Headaches and neck pain following a concussion are potentially treatable and resolve over&#xD;
      time. Nerve blockade may enhance the recovery of appropriate neural circuits involved in the&#xD;
      pathophysiology of a chronic headache. Currently, no evidence-based guidelines exist for&#xD;
      treatment of PTH. Adoption of &quot;brain rest&quot; for 1-2 weeks, followed by gradual return to&#xD;
      activity and avoiding &quot;second-impact syndrome&quot; are current practice. The use of medications&#xD;
      controlling neuropathic pain is of partial benefit for some. Adverse effects like sedation,&#xD;
      mood changes, cardiac side effects of pharmacologic agents are often not compatible with the&#xD;
      demands of athletics. For those patients where sports performance is paramount, they may&#xD;
      therefore not be able to tolerate regular medications. The incidence of chronic&#xD;
      post-concussive headaches (&gt; 3 months) at one year is 8.4% - 35% and at four years is up to&#xD;
      25%. Therefore, patients can have a significant disability from their post-traumatic&#xD;
      headaches for many years after their injury. Without appropriate treatment, these headaches&#xD;
      can remain as chronic headaches. Over-the-counter and other symptomatic medication overuse&#xD;
      can exacerbate and prolong PTH significantly, secondary to rebound headaches. Successful&#xD;
      treatment is essential since PTH limits return to sports as well as more general activities&#xD;
      of living, such as work and school. Most interventions currently in use partially help and&#xD;
      take several weeks to months for a noticeable benefit. PTH interventions, including ONB and&#xD;
      CMBB, are employed in the treatment of primary headache disorders and neck pain from cervical&#xD;
      arthritis and may provide more improved, faster and more sustained pain relief in many&#xD;
      patients. Also, given that most of the action of the nerve blocks is local, there are&#xD;
      significantly fewer side effects than in more standard headache medications. Injections that&#xD;
      use corticosteroids may be beneficial in a post-traumatic headache by reducing inflammation&#xD;
      and therefore mechanical allodynia. Injection of corticosteroids in the cervical facet joint&#xD;
      area has shown up to 13 months of pain relief. This prolonged effect may be secondary to&#xD;
      central pain modulation. Ultimately, nerve blocks may be a more effective and efficient&#xD;
      post-traumatic headache given the onset of effect and the minimal side effects.&#xD;
&#xD;
      To date, there have been no prospective studies of procedural treatments for medically&#xD;
      refractory PTH and none in the adolescent and young adult population in whom football&#xD;
      injuries are common. Despite the frequent clinical practice of using ONB and CMBB for&#xD;
      occipital neuralgia, cervical arthritis, and cervicogenic headaches, there has been no&#xD;
      adequate scientific investigation into the use of these interventions for PTH. Given that PTH&#xD;
      is typically felt to be secondary to an inflammatory reaction to trauma, the use of injection&#xD;
      of corticosteroids may be more effective in PTH than in common headache disorders.&#xD;
&#xD;
      The investigators propose a randomized, prospective, controlled treatment trial to evaluate&#xD;
      the efficacy of minimally invasive nerve block interventions (ONB and CMBB) as treatments for&#xD;
      PTH and neck pain in adolescents and adults aged 14-45 years of age with PTH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain intensity scores using the numerical rating scale (NRS)</measure>
    <time_frame>Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Headache Frequency assessed by Migraine Disability Assessment (MIDAS)</measure>
    <time_frame>Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)</time_frame>
    <description>Self-administered questionnaire to quantify headache-related disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache Frequency assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)</measure>
    <time_frame>Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)</time_frame>
    <description>Self-administered questionnaire to quantify headache-related disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache severity assessed by Migraine Disability Assessment (MIDAS)</measure>
    <time_frame>Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)</time_frame>
    <description>Self-administered questionnaire to quantify headache-related disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache severity assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)</measure>
    <time_frame>Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)</time_frame>
    <description>Self-administered questionnaire to quantify headache-related disability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Disability Scores</measure>
    <time_frame>Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)</time_frame>
    <description>Assessed using the Functional Disability Inventory (FDI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment assessed by Quality of Life Assessment (QL)</measure>
    <time_frame>Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)</time_frame>
    <description>Standardized questionnaire that assess adult patients perceptions of health-related quality of life (HRQOL) with chronic health conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Assessment assessed by the Pediatric QL (PedsQL)</measure>
    <time_frame>Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)</time_frame>
    <description>Standardized questionnaire that assess a pediatric patients/parent's perceptions of health-related quality of life (HRQOL) with chronic health conditions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">63</enrollment>
  <condition>Post-Traumatic Headaches</condition>
  <arm_group>
    <arm_group_label>Occipital Nerve Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a &gt; or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.&#xD;
If patients exhibit &lt; 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cervical Medial Branch Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a &gt; or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.&#xD;
If patients exhibit &lt; 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Occipital Nerve Block (ONB) using lidocaine and dexamethosone</intervention_name>
    <description>Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites.</description>
    <arm_group_label>Occipital Nerve Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone</intervention_name>
    <description>Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side.</description>
    <arm_group_label>Cervical Medial Branch Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 14 - 45 years&#xD;
&#xD;
          -  History of post-traumatic headache or neck pain following a concussion or head injury&#xD;
             within the last 12 months&#xD;
&#xD;
          -  Self-reported lack of meaningful benefit with at least one previous treatment trial.&#xD;
             Previous treatment could include a migraine prophylactic medication, a neuropathic&#xD;
             pain medication, a physical intervention, or a cognitive-behavioral intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant underlying psychological concerns, as determined by study psychologist up&#xD;
             on review of standardized assessment&#xD;
&#xD;
          -  Lack of parental consent and child assent (if patient age &lt;18 years) or lack of&#xD;
             consent (if patient age &gt;18 years). Unable to complete the questionnaire, based on&#xD;
             parental or patient estimation of cognitive or language limitations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pradeep Dinakar, MD</last_name>
    <phone>857-218-3556</phone>
    <email>Pradeep.Dinakar@childrens.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kimberly Lobo, MPH</last_name>
    <phone>857-218-3556</phone>
    <email>Kimberly.Lobo@childrens.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kimberly Lobo, MPH</last_name>
      <phone>857-218-3556</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandra Stillman, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>September 21, 2022</last_update_submitted>
  <last_update_submitted_qc>September 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Pradeep Dinakar, MD, MS, FAAP</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology, Harvard Medical School; Staff Physician, Boston Children's Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Post-Traumatic Headache</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators do not plan to share any IPD collected during the study with other researchers not included in the protocol.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03007420
org study id: IRB-P00025021
nct id: NCT03007420
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury,
      possibly generated by a number of stressors to the trigeminovascular and cervical plexus
      networks, including inflammation of the high cervical facet joints, traumatic cranial
      neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for
      PTH management except for conservative modalities, such as cognitive rest, physical therapy,
      and neuropathic pain medications, all of which have minimal evidence to support them.

      The investigators propose a randomized, controlled, clinical trial and prospective follow-up
      study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and
      cervical medial branch block (CMBB) in the management of PTH.

      Adolescents and adults (14-45 years of age) will be recruited from Boston Children's Hospital
      and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache
      clinics.
Headaches and neck pain following a concussion are potentially treatable and resolve over
      time. Nerve blockade may enhance the recovery of appropriate neural circuits involved in the
      pathophysiology of a chronic headache. Currently, no evidence-based guidelines exist for
      treatment of PTH. Adoption of "brain rest" for 1-2 weeks, followed by gradual return to
      activity and avoiding "second-impact syndrome" are current practice. The use of medications
      controlling neuropathic pain is of partial benefit for some. Adverse effects like sedation,
      mood changes, cardiac side effects of pharmacologic agents are often not compatible with the
      demands of athletics. For those patients where sports performance is paramount, they may
      therefore not be able to tolerate regular medications. The incidence of chronic
      post-concussive headaches (> 3 months) at one year is 8.4% - 35% and at four years is up to
      25%. Therefore, patients can have a significant disability from their post-traumatic
      headaches for many years after their injury. Without appropriate treatment, these headaches
      can remain as chronic headaches. Over-the-counter and other symptomatic medication overuse
      can exacerbate and prolong PTH significantly, secondary to rebound headaches. Successful
      treatment is essential since PTH limits return to sports as well as more general activities
      of living, such as work and school. Most interventions currently in use partially help and
      take several weeks to months for a noticeable benefit. PTH interventions, including ONB and
      CMBB, are employed in the treatment of primary headache disorders and neck pain from cervical
      arthritis and may provide more improved, faster and more sustained pain relief in many
      patients. Also, given that most of the action of the nerve blocks is local, there are
      significantly fewer side effects than in more standard headache medications. Injections that
      use corticosteroids may be beneficial in a post-traumatic headache by reducing inflammation
      and therefore mechanical allodynia. Injection of corticosteroids in the cervical facet joint
      area has shown up to 13 months of pain relief. This prolonged effect may be secondary to
      central pain modulation. Ultimately, nerve blocks may be a more effective and efficient
      post-traumatic headache given the onset of effect and the minimal side effects.

      To date, there have been no prospective studies of procedural treatments for medically
      refractory PTH and none in the adolescent and young adult population in whom football
      injuries are common. Despite the frequent clinical practice of using ONB and CMBB for
      occipital neuralgia, cervical arthritis, and cervicogenic headaches, there has been no
      adequate scientific investigation into the use of these interventions for PTH. Given that PTH
      is typically felt to be secondary to an inflammatory reaction to trauma, the use of injection
      of corticosteroids may be more effective in PTH than in common headache disorders.

      The investigators propose a randomized, prospective, controlled treatment trial to evaluate
      the efficacy of minimally invasive nerve block interventions (ONB and CMBB) as treatments for
      PTH and neck pain in adolescents and adults aged 14-45 years of age with PTH.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in pain intensity scores using the numerical rating scale (NRS)
time frame: Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
measure: Headache Frequency assessed by Migraine Disability Assessment (MIDAS)
time frame: Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
description: Self-administered questionnaire to quantify headache-related disability
measure: Headache Frequency assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
time frame: Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
description: Self-administered questionnaire to quantify headache-related disability
measure: Headache severity assessed by Migraine Disability Assessment (MIDAS)
time frame: Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
description: Self-administered questionnaire to quantify headache-related disability
measure: Headache severity assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
time frame: Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
description: Self-administered questionnaire to quantify headache-related disability
measure: Functional Disability Scores
time frame: Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
description: Assessed using the Functional Disability Inventory (FDI)
measure: Quality of Life Assessment assessed by Quality of Life Assessment (QL)
time frame: Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
description: Standardized questionnaire that assess adult patients perceptions of health-related quality of life (HRQOL) with chronic health conditions.
measure: Quality of Life Assessment assessed by the Pediatric QL (PedsQL)
time frame: Baseline, weekly for a period of 2 months from the start of the study, and then bi-weekly for an additional 10 month period (total of 12 months)
description: Standardized questionnaire that assess a pediatric patients/parent's perceptions of health-related quality of life (HRQOL) with chronic health conditions.
arm group label: Occipital Nerve Block
arm group type: Experimental
description: After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a > or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.
If patients exhibit < 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
arm group label: Cervical Medial Branch Block
arm group type: Experimental
description: After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a > or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months.
If patients exhibit < 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
intervention type: Drug
intervention name: Occipital Nerve Block (ONB) using lidocaine and dexamethosone
description: Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites.
arm group label: Occipital Nerve Block
intervention type: Drug
intervention name: Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone
description: Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side.
arm group label: Cervical Medial Branch Block
criteria: 
gender: All
minimum age: 14 Years
maximum age: 45 Years
healthy volunteers: No
last name: Pradeep Dinakar, MD
phone: 857-218-3556
email: Pradeep.Dinakar@childrens.harvard.edu
last name: Kimberly Lobo, MPH
phone: 857-218-3556
email: Kimberly.Lobo@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Pradeep Dinakar, MD, MS, FAAP
investigator title: Assistant Professor of Anesthesiology, Harvard Medical School; Staff Physician, Boston Children's Hospital
mesh term: Post-Traumatic Headache
mesh term: Headache
mesh term: Lidocaine
sharing ipd: No
ipd description: The investigators do not plan to share any IPD collected during the study with other researchers not included in the protocol.