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

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.

Study Overview

• Status: Withdrawn
• Conditions: Concussion; Post Concussive Syndrome
• Intervention / Treatment: Device: PEMF

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment PEMF; 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.	Device: PEMF; 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.; Other Names: Pulsed Electromagnetic Field Therapy
Sham Comparator: Sham Treatment; 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.	Device: PEMF; 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.; Other Names: Pulsed Electromagnetic Field Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rivermead Post-Concussion Symptom Questionnaire	basic post-concussion questionaire	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ruff Neurobehavioral Inventory	basic neurobehavioral inventory	6 minutes

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Collaborators: Rio Grande Neurosciences
• Investigators: Principal Investigator: Ross Zafonte, DO, Spaulding Rehabilitation Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Craniocerebral Trauma; Trauma, Nervous System; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Syndrome; Post-Concussion Syndrome
• Other Study ID Numbers: 2014D006902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No