NSI Pulsed Electromagnetic Field (PEMF) Biomarker Study

• ClinicalTrials.gov Identifier: NCT03654014
• Recruitment Status: Unknown
• First Posted: August 31, 2018
• Last Update Posted: August 31, 2018
• Sponsor: University of New Mexico
• Information provided by (Responsible Party): Edwin Nemoto, University of New Mexico

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury	Device: SofPulse	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blinded treatment with PEMF+ and PEMF- groups with CSF and serum biomarkers compared to values from patients with normal pressure hydrocephalus.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Honest broker will determine and record PEMF+ and PEMF- treated patients keeping investigator team blinded as to treatment until data analysis has been completed.
• Primary Purpose: Treatment
• Official Title: 14-113 Nemoto: NSI PEMF Biomarker Study
• Estimated Study Start Date: September 1, 2018
• Estimated Primary Completion Date: August 17, 2019
• Estimated Study Completion Date: November 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. CSF and serum biomarkers [ Time Frame: CSF and serum collection from Zero to 7 days after injury ]
   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.

Secondary Outcome Measures :

1. Glasgow Coma Score [ Time Frame: Admission, daily for 7 days, discharge from hospital and one and three months ]

   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

2. Glasgow Outcome Score Extended [ Time Frame: Admission, daily for 7 days, discharge from hospital and one and three months ]

   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.

   1. Death D
   2. Vegetative state VS
   3. Lower severe disability SD -
   4. Upper severe disability SD +
   5. Lower moderate disability MD -
   6. Upper moderate disability MD +
   7. Lower good recovery GR -
   8. Upper good recovery GR
3. Modified Rankin Scale [ Time Frame: Admission, daily for 7 days, discharge from hospital and one and three months ]

   0 No symptoms at all

   1. No significant disability despite symptoms; able to carry out all usual duties and activities
   2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
   3. Moderate disability; requiring some help, but able to walk without assistance
   4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
   5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention
   6. Dead

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Edwin M Nemoto, PhD; 505-272-5990; Enemoto@salud.unm.edu

Contact: Amal Alchbli, MD; 505-272-6094; Aalchbli@salud.unm.edu

Locations

United States, New Mexico

University of New Mexico; Recruiting

Albuquerque, New Mexico, United States, 87131

Contact: Edwin M Nemoto, PhD 505-272-5990 Enemoto@salud.unm.edu

Contact: Amal Alchbli, MD 505-272-6094 Aalchbli@salud.unm.edu

Sponsors and Collaborators

University of New Mexico

Investigators

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

More Information

• Responsible Party: Edwin Nemoto, Research Professor, University of New Mexico
• ClinicalTrials.gov Identifier: NCT03654014
• Other Study ID Numbers: 14-113
• First Posted: August 31, 2018
• Last Update Posted: August 31, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The study data will be coded and de-identified and shared with the sponsor of the study.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Edwin Nemoto, University of New Mexico:

Pulsed Electromagnetic Field therapy; Traumatic Brain Injury; Neurologic outcome; Cerebrospinal fluid biomarkers; serum biomarkers

Additional relevant MeSH terms:

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