Traumatic Brain InjuryNCT03654014
NSI Pulsed Electromagnetic Field (PEMF) Biomarker Study
A study testing SofPulse in people with Traumatic Brain Injury, run by University of New Mexico at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- SofPulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2018to 7 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: 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).
Read the 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
- Conditions
- Traumatic Brain Injury
- Being tested
- SofPulse
- Keywords
- Pulsed Electromagnetic Field therapy, Traumatic Brain Injury, Neurologic outcome, Cerebrospinal fluid biomarkers, serum biomarkers
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofPulseDevice
SofPulse PEMF device treatment of the brain after traumatic injury
| Study group | Role | What they receive |
|---|---|---|
| SofPulse active | Experimental | 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. Receives: Device: SofPulse |
| SofPulse inactive | Placebo comparator | SofPulse inactive. The SofPulse will be placed on the patient's head but not activated for as long as they are in intensive care. Receives: Device: SofPulse |
| Normal pressure hydrocephalus | Sham comparator | 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. Receives: Device: SofPulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: CSF and serum collection from Zero to 7 days after injury
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Admission, daily for 7 days, discharge from hospital and one and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start12 Feb 2018
- Primary completion7 Apr 2020
- Study completion7 Apr 2020
Why it stopped: Changes in study personnel (PI retired) and the Sponsor terminated the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edwin Nemoto, University of New Mexico
- Investigators
- Edwin M Nemoto, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654014
- Sponsor's protocol ID
- 14-113
- Status last verified
- Aug 2018
- First submitted
- 25 Apr 2018
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The study data will be coded and de-identified and shared with the sponsor of the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 14-113 Nemoto: NSI PEMF Biomarker Study
- ClinicalTrials.gov ID
- NCT03654014
- Acronym / sponsor ID
- 14-113
- Conditions
- Traumatic Brain Injury
- Keywords
- Pulsed Electromagnetic Field therapy, Traumatic Brain Injury, Neurologic outcome, Cerebrospinal fluid biomarkers, serum biomarkers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in study personnel (PI retired) and the Sponsor terminated the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 7 Apr 2020 (actual)
- Study completion
- 7 Apr 2020 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double blinded treatment with PEMF+ and PEMF- groups with CSF and serum biomarkers compared to values from patients with normal pressure hydrocephalus.
| Arm | Type | Receives |
|---|---|---|
| SofPulse active | Experimental | Device: SofPulseSofPulse 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. |
| SofPulse inactive | Placebo comparator | Device: SofPulseSofPulse inactive. The SofPulse will be placed on the patient's head but not activated for as long as they are in intensive care. |
| Normal pressure hydrocephalus | Sham comparator | Device: SofPulseCSF and serum samples from 15 normal pressure hydrocephalus patients will be used to compare CSF and serum biomarker levels in the 30 TBI patients. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SofPulseSofPulse PEMF device treatment of the brain after traumatic injury | Device | Normal pressure hydrocephalus, SofPulse active, SofPulse inactive |
Primary outcome
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.
3 secondary outcomes
Glasgow Coma Score
Time frame: Admission, daily for 7 days, discharge from hospital and one and three months
Glasgow Outcome Score Extended
Time frame: Admission, daily for 7 days, discharge from hospital and one and three months
Modified Rankin Scale
Time frame: Admission, daily for 7 days, discharge from hospital and one and three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No. The study data will be coded and de-identified and shared with the sponsor of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin M Nemoto, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SofPulse in people with Traumatic Brain Injury, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF and serum biomarkers (time frame: CSF and serum collection from Zero to 7 days after injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.