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

NCT02643836 | Withdrawn DMC

• 1 other identifier: 2014D006902
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Post Concussive Syndrome; Concussion

Outcome Measures

Primary Outcomes (1)

• Rivermead Post-Concussion Symptom Questionnaire

  basic post-concussion questionaire

  5 minutes

Secondary Outcomes (1)

• Ruff Neurobehavioral Inventory

  6 minutes

Study Arms (2)

Treatment PEMF

EXPERIMENTAL

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

Sham Treatment

SHAM COMPARATOR

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

Interventions

PEMF DEVICE

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.

Also known as: Pulsed Electromagnetic Field Therapy

Sham Treatment; Treatment PEMF

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Rio Grande Neurosciences: collaborator

Related Publications (1)

• 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.

  PMID: 16179657 RESULT

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Concussion

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Ross Zafonte, DO

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Physical Medicine and Rehabilitation, Harvard Medical School

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: December 31, 2015
• Study Start: September 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 9, 2018

Record last verified: 2018-05