Concussion Clinical Trial
Official title:
Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome
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.
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.
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