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

NCT02643836 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-05-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Rio Grande Neurosciences

    collaborator INDUSTRY

  • Spaulding Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Ross Zafonte, DO · Spaulding Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2016-09-01
Completion
2016-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02643836 on ClinicalTrials.gov