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Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome (PEMF)

Primary Purpose

Post Concussive Syndrome, Concussion

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PEMF
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Concussive Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of a mild or moderate traumatic brain injury in the previous 6 months related to a sports injury
  • Symptomatic Rivermead Postconcussion Symptom Questionnaire (RPQ) scores (RPQ 3 > 3, RPQ 13 >8)
  • Age 18-30
  • Willing and able to sign informed consent
  • Willing and able to attend all study assessments

Exclusion Criteria:

  • Severe traumatic brain injury defined by a post-injury Glasgow Coma Scale score ≤ 8 greater than 30 minutes following the injury or post-traumatic amnesia lasting longer than 1 week
  • Time since injury less than 4 weeks or greater than 6 months
  • Any concussion that is not sustained during sports activity
  • Concussions sustained during mixed martial arts or boxing activities
  • Positive CT scan or MRI related to brain injury
  • Recently beginning methylphenidate or amphetamine-dextroamphetamine treatment within two months
  • Pre-existing diagnosis of learning disability or neurodevelopmental disorder (other than ADD/ADHD)
  • Pre-existing significant neurological disorder (e.g., seizures, CNS neoplasms) or history of neurosurgical intervention
  • Prior psychiatric hospitalization
  • Current substance abuse or dependence (AUDIT-C)
  • Pacemaker
  • Implanted stimulation devices
  • Pregnant
  • Unstable medical conditions
  • Unable to read and/or understand the purpose and participating conditions of the study
  • Any condition that would prevent participation in study procedures or condition the investigator believes would make the subject unsuitable for participation in the study.
  • Non-English speaking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Treatment PEMF

    Sham Treatment

    Arm Description

    The investigators will recruit and enroll 76 patients (between 18 and 30 years of age) who have had persistent symptoms consistent with PCS for at least 4 weeks, but not more than 6 months, after the initial injury. The experimental group will contain 38 subjects. Each study subject will receive two hats, which contain the integrated PEMF device, this will be done to ensure continuity of treatment in case that one of the hats stops working due to the battery running out. The subjects will receive PEMF treatment for 15 minutes three times per day for 6 weeks. Upon enrollment and at the end of the 6-week treatment period, all subjects will undergo a comprehensive assessment that will include symptom inventories, neuropsychological tests, qEEG measurement and near-infrared spectroscopy. The investigators will conduct a 3-month follow-up to assess longer-term outcomes.

    The investigators will recruit and enroll 76 patients (between 18 and 30 years of age) who have had persistent symptoms consistent with PCS for at least 4 weeks, but not more than 6 months, after the initial injury. The sham group will contain 38 subjects. Each study subject will receive two hats, which contain a de-activated PEMF device, the device will still be blinking to show sham treatment activity. The sham subjects will receive the sham treatment for 15 minutes three times per day for 6 weeks. Upon enrollment and at the end of the 6-week treatment period, all subjects will undergo a comprehensive assessment that will include symptom inventories, neuropsychological tests, qEEG measurement and near-infrared spectroscopy. The investigators will conduct a 3-month follow-up to assess longer-term outcomes.

    Outcomes

    Primary Outcome Measures

    Rivermead Post-Concussion Symptom Questionnaire
    basic post-concussion questionaire

    Secondary Outcome Measures

    Ruff Neurobehavioral Inventory
    basic neurobehavioral inventory

    Full Information

    First Posted
    October 8, 2015
    Last Updated
    May 3, 2018
    Sponsor
    Spaulding Rehabilitation Hospital
    Collaborators
    Rio Grande Neurosciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02643836
    Brief Title
    Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome
    Acronym
    PEMF
    Official Title
    Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    September 1, 2016 (Actual)
    Study Completion Date
    September 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Spaulding Rehabilitation Hospital
    Collaborators
    Rio Grande Neurosciences

    4. Oversight

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

    5. Study Description

    Brief Summary
    The objectives are to evaluate impact of Pulsed electromagnetic field (PEMF) therapy on patients with Post-Concussive Syndrome with Rivermead Post Concussion Symptom Questionnaire (RPQ) as a primary outcome, followed by fatigue and mood as second and tertiary outcomes respectively. The investigators will also investigate brain tissue activity and oxygenation by evaluating brain wave activity via non-invasive quantitative electroencephalogram and near infrared spectroscopy testing pre and post study to better understand the metabolic effect of the PEMF intervention. The investigators hypothesize that the PEMF treatment will have an effect on improvement of brain metabolism as measured by Near Infrared Spectroscopy which will in turn assist with improvement of the chronic symptoms of cognitive deficits, mood and fatigue as related to Post-Concussive Syndrome.
    Detailed Description
    76 subjects will be enrolled for this experiment. Each subject will go through the screening procedure as outlined above. After consent and screening are complete each subject will receive a hat that delivers three 15 minute stimulations per day for the duration of 6 weeks. Each study subject will receive two hats, which contain the integrated PEMF device, this will be done to ensure continuity of treatment in case that one of the hats stops working due to the battery running out. The PEMF device to be used will be an investigational, battery powered custom-made stimulator able to deliver an electromagnetic field. This device operates at very low amplitude (0.05 gauss magnetic field strength) and requires only watch batteries for power, which allows the technology to be portable (e.g., used at home), versatile, inexpensive, and safe, (vi) we have integrated the PEMF device into a wearable baseball hat to improve tolerance and compliance and can also monitor patient use in this configuration. The study device consists of a printed circuit board PEMF signal generator and an AAA battery-driven power supply encased in high density plastic, a solid wire-loop antenna covered in medical grade silicone, all of which are built into a standard baseball-style cap, with the antenna fitted around its largest internal circumference. The device was designed to be easily used and is activated by donning the cap. Once donned, a 15-minute treatment cycle starts and stops automatically. The device requires at least 2 hours between treatments, and cannot be activated again until that period has elapsed. A light on the power supply blinks while the unit is active. EEG and NIR will be obtained at visits 1, 2 and at three month follow up to better evaluate brain oxygenation and metabolism.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment PEMF
    Arm Type
    Experimental
    Arm Description
    The investigators will recruit and enroll 76 patients (between 18 and 30 years of age) who have had persistent symptoms consistent with PCS for at least 4 weeks, but not more than 6 months, after the initial injury. The experimental group will contain 38 subjects. Each study subject will receive two hats, which contain the integrated PEMF device, this will be done to ensure continuity of treatment in case that one of the hats stops working due to the battery running out. The subjects will receive PEMF treatment for 15 minutes three times per day for 6 weeks. Upon enrollment and at the end of the 6-week treatment period, all subjects will undergo a comprehensive assessment that will include symptom inventories, neuropsychological tests, qEEG measurement and near-infrared spectroscopy. The investigators will conduct a 3-month follow-up to assess longer-term outcomes.
    Arm Title
    Sham Treatment
    Arm Type
    Sham Comparator
    Arm Description
    The investigators will recruit and enroll 76 patients (between 18 and 30 years of age) who have had persistent symptoms consistent with PCS for at least 4 weeks, but not more than 6 months, after the initial injury. The sham group will contain 38 subjects. Each study subject will receive two hats, which contain a de-activated PEMF device, the device will still be blinking to show sham treatment activity. The sham subjects will receive the sham treatment for 15 minutes three times per day for 6 weeks. Upon enrollment and at the end of the 6-week treatment period, all subjects will undergo a comprehensive assessment that will include symptom inventories, neuropsychological tests, qEEG measurement and near-infrared spectroscopy. The investigators will conduct a 3-month follow-up to assess longer-term outcomes.
    Intervention Type
    Device
    Intervention Name(s)
    PEMF
    Other Intervention Name(s)
    Pulsed Electromagnetic Field Therapy
    Intervention Description
    The PEMF device (Rio Grande Neurosciences - RGN) the investigators would be testing has been shown to have significant anti-inflammatory effects in animals and humans and an excellent safety profile in several clinical studies. Key findings demonstrated that PEMF-treated rodents with a closed-head TBI exhibited a 5-fold decrease in IL-1b in the cerebral spinal fluid, an outcome associated with decreased neuropathology and improved function.
    Primary Outcome Measure Information:
    Title
    Rivermead Post-Concussion Symptom Questionnaire
    Description
    basic post-concussion questionaire
    Time Frame
    5 minutes
    Secondary Outcome Measure Information:
    Title
    Ruff Neurobehavioral Inventory
    Description
    basic neurobehavioral inventory
    Time Frame
    6 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of a mild or moderate traumatic brain injury in the previous 6 months related to a sports injury Symptomatic Rivermead Postconcussion Symptom Questionnaire (RPQ) scores (RPQ 3 > 3, RPQ 13 >8) Age 18-30 Willing and able to sign informed consent Willing and able to attend all study assessments Exclusion Criteria: Severe traumatic brain injury defined by a post-injury Glasgow Coma Scale score ≤ 8 greater than 30 minutes following the injury or post-traumatic amnesia lasting longer than 1 week Time since injury less than 4 weeks or greater than 6 months Any concussion that is not sustained during sports activity Concussions sustained during mixed martial arts or boxing activities Positive CT scan or MRI related to brain injury Recently beginning methylphenidate or amphetamine-dextroamphetamine treatment within two months Pre-existing diagnosis of learning disability or neurodevelopmental disorder (other than ADD/ADHD) Pre-existing significant neurological disorder (e.g., seizures, CNS neoplasms) or history of neurosurgical intervention Prior psychiatric hospitalization Current substance abuse or dependence (AUDIT-C) Pacemaker Implanted stimulation devices Pregnant Unstable medical conditions Unable to read and/or understand the purpose and participating conditions of the study Any condition that would prevent participation in study procedures or condition the investigator believes would make the subject unsuitable for participation in the study. Non-English speaking
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ross Zafonte, DO
    Organizational Affiliation
    Spaulding Rehabilitation Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16179657
    Citation
    Boake C, McCauley SR, Levin HS, Pedroza C, Contant CF, Song JX, Brown SA, Goodman H, Brundage SI, Diaz-Marchan PJ. Diagnostic criteria for postconcussional syndrome after mild to moderate traumatic brain injury. J Neuropsychiatry Clin Neurosci. 2005 Summer;17(3):350-6. doi: 10.1176/jnp.17.3.350.
    Results Reference
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    Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome

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