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Lost funding from sponsor
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| Name | Class |
|---|---|
| Innovative Health Solutions | INDUSTRY |
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The purpose of this study is to evaluate the ability of Neuro-Stim System, a non-pharmacologic alternative for pain management, to reduce pain and treat insomnia. Neuro-Stim System uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system.
Pain is a complex problem that complicates recovery and rehabilitation after traumatic injury and surgery. The physician must balance pain management therapies against the potential for side effects and complications. Most of the treatment options for pain are pharmacological and have the potential for serious side effects and drug interactions. A non-pharmacological treatment would reduce the risk of adverse events and likely enhance the overall multimodal pain plan. The purpose of this study is to evaluate the effectiveness of Neuro-Stim System (NSS), a non-pharmacological option that uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system, to treat pain and improve sleep. Pain patients will be asked to participate in a study to evaluate the ability of Neuro-Stim System to reduce pain and to treat insomnia. NSS is a Federal Drug Administration (FDA) approved device intended to be used for chronic and acute pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Neurostim System (Sham NSS) | Sham Comparator | In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device. |
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| Working Neurostim System (Working NSS) | Experimental | In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental NSS | Device | 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS) | The primary outcome is pain measured by the Defense and Veterans Pain Rating Scale (DVPRS) from 0-10 at baseline, 15 minutes, and daily for 5 days after application. Rate the severity of your CURRENT pain: 0 - No Pain
Higher values represent worse outcomes | baseline to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Modified PROMIS for Pain Intensity | Use the scale to answer the following questions for Pain Intensity in the past 24 hours, 1=had no pain 2=Mild 3= Moderate 4= Severe 5=Very Severe
Higher values represent worse outcomes | baseline to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Modified PROMIS for Pain Interference | Use the following scale to to answer the questions about Pain Interference in the last 24 hours 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much
| baseline to 10 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chester Buckenmaier, MD | Uniformed Services University of the Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham NSS | In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device. Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear. |
| FG001 | NSS (Working Device) | In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device. Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Study lost funding in the early stages therefore we were unable to collect enough data to do any analyzing.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham NSS | In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device. Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Measured Via the Defense and Veterans Pain Scale v2.0 (DVPRS) | The primary outcome is pain measured by the Defense and Veterans Pain Rating Scale (DVPRS) from 0-10 at baseline, 15 minutes, and daily for 5 days after application. Rate the severity of your CURRENT pain: 0 - No Pain
Higher values represent worse outcomes | Sufficient data was not collected and the study was terminated. No data analysis was done due to loss of funding in the early stages of project. | Posted | baseline to 5 days |
|
STUDY LOST FUNDING IN THE EARLY STAGES The total duration of this study was 3 months, we did not have any adverse events to report.
We did not have any adverse events to report for the duration of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham NSS | In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device. Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear. |
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Early termination leading to small numbers of subjects analyzed. Lost funding in the early stages of the project which ended recruitment to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary McDuffie | Defense and Veterans Center for Integrative Pain Management | 301-400-4242 | mmcduffie@dvcipm.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Sham NSS | Device | (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear. |
|
| Modified PROMIS for Sleep Disturbance | Use the scale to answer the following question regarding Sleep Disturbance in the past 24 hours 1=Very Poor 2=Poor 3= Fair 4= Good 5=Very Good 1. My sleep quality was... Use the scale to answer the following questions regarding Sleep Disturbance in the past 24 hours 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much
| baseline to 10 days |
| BG001 | NSS (Working Device) | In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device. Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device.
Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear.
| OG001 | Sham NSS | In this arm, the subject will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive a sham Neuro-Stim System device that will only be active for five minutes. Identical to the active device in placement, labeling, and packaging. It will remain on the subject's ear for 5 days at which point the subject may discard the device. Sham NSS: (5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear. |
|
| Secondary | Modified PROMIS for Pain Intensity | Use the scale to answer the following questions for Pain Intensity in the past 24 hours, 1=had no pain 2=Mild 3= Moderate 4= Severe 5=Very Severe
Higher values represent worse outcomes | Sufficient data was not collected and the study was terminated. No data analysis was done due to loss of funding in the early stages of project. | Posted | baseline to 10 days |
|
|
| Other Pre-specified | Modified PROMIS for Pain Interference | Use the following scale to to answer the questions about Pain Interference in the last 24 hours 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much
| No data analysis was done due to loss of funding in the early stages of project. | Posted | baseline to 10 days |
|
|
| Other Pre-specified | Modified PROMIS for Sleep Disturbance | Use the scale to answer the following question regarding Sleep Disturbance in the past 24 hours 1=Very Poor 2=Poor 3= Fair 4= Good 5=Very Good 1. My sleep quality was... Use the scale to answer the following questions regarding Sleep Disturbance in the past 24 hours 1=Not at all 2=A little bit 3= Somewhat 4= Quite a bit 5=Very much
| No data analysis was done due to loss of funding in the early stages of project. | Posted | baseline to 10 days |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | NSS (Working Device) | In this arm, the patient will receive the standard-of-care with regard to his pain management (which may or may not include opioids such as morphine). Additionally, the subject will receive an active Neuro-Stim System that generates electrical impulses that stimulate the neurovascular bundles in the ear. It will remain on subject's ear for 5 days at which point the subject may discard the device. Experimental NSS: 5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear. | 0 | 8 | 0 | 8 | 0 | 8 |
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