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Sponsor Decision
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The purpose of this prospective study is to investigate the efficacy of the Bridge™ device in reducing the symptoms of opioid withdrawal in a blind comparison to a sham device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bridge™ active device | Active Comparator | The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. |
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| Bridge™ sham device | Sham Comparator | The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bridge™ active device | Device | Bridge is a percutaneous nerve field stimulation device |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Score Range: The COWS score can range from 0 to 48. Interpretation: 0-4: No withdrawal 5-12: Mild withdrawal 13-24: Moderate withdrawal 25-36: Moderately severe withdrawal 37-48: Severe withdrawal High scores mean more severe withdrawal. | prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. High scores mean worse symptom intensity. | prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caron Treatment Centers | Wernersville | Pennsylvania | 19565 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bridge™ Active Device | The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge™ active device: Bridge is a percutaneous nerve field stimulation device |
| FG001 | Bridge™ Sham Device | The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Bridge™ sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bridge™ Active Device | The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge™ active device: Bridge is a percutaneous nerve field stimulation device |
| BG001 | Bridge™ Sham Device |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score | The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale designed to be administered by a clinician. This tool can be used in both inpatient and outpatient settings to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. Score Range: The COWS score can range from 0 to 48. Interpretation: 0-4: No withdrawal 5-12: Mild withdrawal 13-24: Moderate withdrawal 25-36: Moderately severe withdrawal 37-48: Severe withdrawal High scores mean more severe withdrawal. | The study was terminated prematurely due to sponsor decision with no clinical rationale for the termination. This was a prospective study investigating the test device. Of 13 subjects using the device, only 6 completed the study. The sample size is well below the threshold needed to perform reliable statistical comparisons. We reported all demographic data and outcome measure data from the limited sample. Further data reporting would be statistically inappropriate due to the sample size. | Posted | Number | score on a scale | prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use |
Through end of study participation (approximately 3 weeks)
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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 | Bridge™ Active Device | The active Bridge device delivers electrical stimulation to the cranial and occipital nerves. Bridge™ active device: Bridge is a percutaneous nerve field stimulation device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Nervous system disorders | Non-systematic Assessment | Pain or discomfort at the site of device application |
The study was terminated prematurely due to sponsor decision with no clinical rationale for termination. This prospective study investigated a test device deemed "end-of-life" by the manufacturer. Only 13 subjects used devices of 48 anticipated; 6 subjects completed the study (3 with active device, 3 with shame device).
We reported all demographic data and outcome measure data from the limited sample size. Further data reporting would be statistically inappropriate due to the sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo Corporation | 9492977000 | clinicalresearchdept@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Rev B | Jun 21, 2024 | Sep 16, 2025 | Prot_SAP_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Rev A | Nov 1, 2022 | Sep 16, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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A randomization table will be kept with the sponsor. Subjects and study site staff (investigators, researchers, care providers) will be blinded to the group assignment.
| Bridge™ sham device | Device | The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses. |
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The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses
Bridge™ sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score | The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. High scores mean worse symptom intensity. | The study was terminated prematurely due to sponsor decision with no clinical rationale for the termination. This was a prospective study investigating the test device. Of 13 subjects using the device, only 6 completed the study. The sample size is well below the threshold needed to perform reliable statistical comparisons. We reported all demographic data and outcome measure data from the limited sample. Further data reporting would be statistically inappropriate due to the sample size. | Posted | Number | score on a scale | prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device use |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Bridge™ Sham Device | The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses Bridge™ sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses. | 0 | 3 | 0 | 3 | 1 | 3 |
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| Subject 1 SOWS score device use 30 min (raw data) |
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| Subject 1 SOWS score device use 60 min (raw data) |
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| Subject 1 SOWS score device use 120 min (raw data) |
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| Subject 1 SOWS score device use 2 days (raw data) |
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| Subject 1 SOWS score device use 3 days (raw data) |
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| Subject 1 SOWS score device use 4 days (raw data) |
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| Subject 1 SOWS score device use 5 days (raw data) |
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| Subject 2 SOWS score pre-device placement, 0 min device use (raw data) |
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| Subject 2 SOWS score device use 30 min (raw data) |
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| Subject 2 SOWS score device use 60 min (raw data) |
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| Subject 2 SOWS score device use 120 min (raw data) |
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| Subject 2 SOWS score device use 2 days (raw data) |
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| Subject 2 SOWS score device use 3 days (raw data) |
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| Subject 2 SOWS score device use 4 days (raw data) |
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| Subject 2 SOWS score device use 5 days (raw data) |
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| Subject 3 SOWS score pre-device placement, 0 min device use (raw data) |
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| Subject 3 SOWS score device use 30 min (raw data) |
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| Subject 3 SOWS score device use 60 min (raw data) |
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| Subject 3 SOWS score device use 120 min (raw data) |
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| Subject 3 SOWS score device use 2 days (raw data) |
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| Subject 3 SOWS score device use 3 days (raw data) |
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| Subject 3 SOWS score device use 4 days (raw data) |
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| Subject 3 SOWS score device use 5 days (raw data) |
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| Subject 4 SOWS score pre-device placement, 0 min device use (raw data) |
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| Subject 4 SOWS score device use 30 min (raw data) |
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| Subject 4 SOWS score device use 60 min (raw data) |
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| Subject 4 SOWS score device use 120 min (raw data) |
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| Subject 4 SOWS score device use 2 days (raw data) |
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| Subject 4 SOWS score device use 3 days (raw data) |
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| Subject 4 SOWS score device use 4 days (raw data) |
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| Subject 4 SOWS score device use 5 days (raw data) |
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| Subject 5 SOWS score pre-device placement, 0 min device use (raw data) |
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| Subject 5 SOWS score device use 30 min (raw data) |
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| Subject 5 SOWS score device use 60 min (raw data) |
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| Subject 5 SOWS score device use 120 min (raw data) |
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| Subject 5 SOWS score device use 2 days (raw data) |
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| Subject 5 SOWS score device use 3 days (raw data) |
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| Subject 5 SOWS score device use 4 days (raw data) |
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| Subject 5 SOWS score device use 5 days (raw data) |
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| Subject 6 SOWS score pre-device placement, 0 min device use (raw data) |
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| Subject 6 SOWS score device use 30 min (raw data) |
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| Subject 6 SOWS score device use 60 min (raw data) |
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| Subject 6 SOWS score device use 120 min (raw data) |
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| Subject 6 SOWS score device use 2 days (raw data) |
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| Subject 6 SOWS score device use 3 days (raw data) |
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| Subject 6 SOWS score device use 4 days (raw data) |
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| Subject 6 SOWS score device use 5 days (raw data) |
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