Clinical Trial: Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome
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 Summary:
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.
Sponsor: Spaulding Rehabilitation Hospital
Current Primary Outcome: Rivermead Post-Concussion Symptom Questionnaire [ Time Frame: 5 minutes ]
Original Primary Outcome: Rivermead Post-Concussion Symptom Questionnaire [ Time Frame: 5 minutes ]
Current Secondary Outcome: Ruff Neurobehavioral Inventory [ Time Frame: 6 minutes ]
Original Secondary Outcome: Ruff Neurobehavioral Inventory [ Time Frame: 6 minutes ]
Information By: Spaulding Rehabilitation Hospital
Dates:
Date Received: October 8, 2015
Date Started: January 2017
Date Completion: January 2019
Last Updated: August 10, 2016
Last Verified: August 2016
