NSI Pulsed Electromagnetic Field (PEMF) Biomarker Study

14-113 Nemoto: NSI PEMF Biomarker Study

Pulsed Electromagnetic Field (PEMF) Reduction of CSF and Serum Biomarkers After Traumatic Brain Injury (TBI).

The primary objective of this pilot study is to determine whether PEMF treatment (PEMF+) reduces the magnitude and duration of the increase in CSF and blood biomarkers after traumatic brain injury (TBI) compared to a PEMF untreated (PEMF-) group. Values in both groups are compared to uninjured brain CSF and blood biomarker levels obtained from hydrocephalus patients undergoing ventriculo-peritoneal shunt placement. A secondary objective of this pilot study is to determine whether PEMF treatment improves the physiologic status of the brain as evaluated by brain tissue monitors of thermal dilution cerebral blood flow (CBF), intracranial pressure (ICP), and tissue PO2 (PbtO2). Improved physiologic status would be reflected by increased CBF, PbtO2, and reduced ICP. Improved physiologic status may also be inferred from derived variables reflecting improved cerebrovascular and intracranial pressure autoregulation.

A tertiary objective of this pilot study is to obtain preliminary data on the relationship between the time course and magnitude of post-TBI CSF and blood biomarker levels as they relate to three month outcome by Glasgow outcome score extended (GOSE) and modified Rankin Score (mRS).

Study Overview

• Status: Withdrawn
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: SofPulse

Detailed Description

Investigators will enroll a total of 45 subjects, 30 after TBI and 15 patients with hydrocephalus having ventriculo-peritoneal shunts inserted. It is anticipated that in order to enroll 30 TBI participants investigators will need to screen approximately 50 subjects; and for the patients undergoing ventriculo-peritoneal shunt placement we will need to screen 30 patients in order to enroll 15. Of the 30 TBI patients, 15 will have PEMF+ and 15 will have PEMF-. PEMF+ means that the device will be in place and will be on, PEMF- means that the device will be in place but will not be turned on.

The study will be double blinded. The honest broker (HB) Dr. Amal Alchbli, will not be involved in the study except to turn on the PEMF device with the indicator light showing when the PEMF device is on , will be hidden from view by tape. The HB will keep a list of the patients treated with PEMF+ or not PEMF- along with their MRN# coded and the start and end times of PEMF treatment during their stay in the NSI. The nurses in the unit will be asked to indicate on the CNS monitor when the PEMF applicators are on or off the patient.

The subjects will participate in this study for up to one week while in the Neuroscience Intensive Care Unit (NSI). There will also be follow up on secondary clinical outcome measures at discharge, one and three months post discharge. The one and three month follow ups will be conducted over the phone.

The duration of enrollment is expected to be two years. The estimated date for the investigators to complete this study (complete primary analyses) is 3.0 years.

The estimated time for data retention is 5 years.

Table 1: Clinical evaluations throughout the study in both TBI and CVA patients.

Scored on TBI patients Admission Impact Score Daily for up to 7 days GCS Discharge GCS One and three months GOSE, DRS, mRS

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edwin M Nemoto, PhD; Phone Number: 505-272-5990; Email: Enemoto@salud.unm.edu
• Study Contact Backup: Name: Amal Alchbli, MD; Phone Number: 505-272-6094; Email: Aalchbli@salud.unm.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Age > 18 years old GCS <9 Male or Female Placement of multimodality monitoring Hummingbird device or an External Ventricular Drain as part of clinical treatment/care.

Multimodality monitoring as part of clinical treatment/care

Exclusion Criteria:

Pregnant Vulnerable population: Prisoners, No legally authorized representative (LAR). Patients with implanted metallic leads. Implants include cardiac pacemakers/defibrillators, cochlear implants, bone growth stimulators, deep brain stimulators, spinal cord stimulators and other nerve stimulators.

Patients without multimodality monitoring or an EVD/Hummingbird Device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SofPulse active; SofPulse active group. Patients who will be treated with the SofPulse activated on their heads for up to seven days in intensive care or as long as they are in the unit The PEMF device is kept on throughout and provides a 15 min pulsed treatment every hour.	Device: SofPulse; SofPulse PEMF device treatment of the brain after traumatic injury
Placebo Comparator: SofPulse inactive; SofPulse inactive. The SofPulse will be placed on the patient's head but not activated for as long as they are in intensive care.	Device: SofPulse; SofPulse PEMF device treatment of the brain after traumatic injury
Sham Comparator: Normal pressure hydrocephalus; CSF and serum samples from 15 normal pressure hydrocephalus patients will be used to compare CSF and serum biomarker levels in the 30 TBI patients.	Device: SofPulse; SofPulse PEMF device treatment of the brain after traumatic injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSF and serum biomarkers	CSF and serum biomarkers: Magnitude of increase and rate of decrease in patients treated with SofPulse active and Sofpulse inactive and both compared to CSF and serum biomarkers in control normal pressure hydrocephalus.	CSF and serum collection from Zero to 7 days after injury

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Coma Score	Coma severity based on Eye (4), Verbal (5), and Motor (6) criteria. Best Eye Response Eyes open spontaneously+4 Eye opening to verbal command+3 Eye opening to pain+2 No eye opening+1 Not assessable (Trauma, edema, etc)C Best Verbal Response Oriented+5 Confused+4 Inappropriate words+3 Incomprehensible sounds+2 No verbal response+1 IntubatedT; Best Motor Response Obeys commands+6 Localizes pain+5 Withdrawal from pain+4 Flexion to pain+3 Extension to pain+2 No motor response+1	Admission, daily for 7 days, discharge from hospital and one and three months
Glasgow Outcome Score Extended	The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOSE) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category: Table 1: Extended Glasgow Outcome Scale (GOSE) Use of the structured interview is recommended to facilitate consistency in ratings.; Death D; Vegetative state VS; Lower severe disability SD -; Upper severe disability SD +; Lower moderate disability MD -; Upper moderate disability MD +; Lower good recovery GR -; Upper good recovery GR	Admission, daily for 7 days, discharge from hospital and one and three months
Modified Rankin Scale	0 No symptoms at all; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	Admission, daily for 7 days, discharge from hospital and one and three months

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Edwin M Nemoto, PhD, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): April 7, 2020
• Study Completion (Actual): April 7, 2020

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Neurologic outcome; serum biomarkers; Pulsed Electromagnetic Field therapy; Cerebrospinal fluid biomarkers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 14-113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study data will be coded and de-identified and shared with the sponsor of the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes