Clinical trial NCT03654014: NSI Pulsed Electromagnetic Field (PEMF) Biomarker Study
Official title: 14-113 Nemoto: NSI PEMF Biomarker Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Pulsed Electromagnetic Field therapy
Traumatic Brain Injury
Neurologic outcome
Cerebrospinal fluid biomarkers
serum biomarkers
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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

Eligibility 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

Primary outcomes:
measure: CSF and serum biomarkers
timeFrame: CSF and serum collection from Zero to 7 days after injury
Secondary outcomes:
measure: Glasgow Coma Score
timeFrame: Admission, daily for 7 days, discharge from hospital and one and three months
measure: Glasgow Outcome Score Extended
timeFrame: Admission, daily for 7 days, discharge from hospital and one and three months
measure: Modified Rankin Scale
timeFrame: Admission, daily for 7 days, discharge from hospital and one and three months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Edwin M Nemoto, PhD
role: PRINCIPAL_INVESTIGATOR
References: