Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome (PEMF)
Post Concussive Syndrome, Concussion
About this trial
This is an interventional treatment trial for Post Concussive Syndrome
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Treatment PEMF
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 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.