Trial Outcomes & Findings for Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms (NCT NCT05924945)
NCT ID: NCT05924945
Last Updated: 2025-10-28
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
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
Results posted on
2025-10-28
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
Impact of Bridge™ Device to Treat Opioid Withdrawal Symptoms
Baseline characteristics by cohort
| Measure |
Bridge™ Active Device
n=6 Participants
The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Bridge™ active device: Bridge is a percutaneous nerve field stimulation device
|
Bridge™ Sham Device
n=7 Participants
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.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device usePopulation: 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.
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.
Outcome measures
| Measure |
Bridge™ Active Device
n=3 Participants
The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Bridge™ active device: Bridge is a percutaneous nerve field stimulation device
|
Bridge™ Sham Device
n=3 Participants
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.
|
|---|---|---|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 1 COWS score pre-device placement, 0 min device use (raw data)
|
—
|
18 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 1 COWS score device use 30 min (raw data)
|
—
|
5 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 1 COWS score device use 60 min (raw data)
|
—
|
3 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 1 COWS score device use 120 min (raw data)
|
—
|
6 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 1 COWS score device use 2 days (raw data)
|
—
|
10 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 1 COWS score device use 3 days (raw data)
|
—
|
8 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 1 COWS score device use 4 days (raw data)
|
—
|
0 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 1 COWS score device use 5 days (raw data)
|
—
|
7 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 2 COWS score pre-device placement, 0 min device use (raw data)
|
—
|
15 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 2 COWS score device use 30 min (raw data)
|
—
|
7 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 2 COWS score device use 60 min (raw data)
|
—
|
3 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 2 COWS score device use 120 min (raw data)
|
—
|
5 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 2 COWS score device use 2 days (raw data)
|
—
|
9 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 2 COWS score device use 3 days (raw data)
|
—
|
13 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 2 COWS score device use 4 days (raw data)
|
—
|
15 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 2 COWS score device use 5 days (raw data)
|
—
|
13 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 3 COWS score pre-device placement, 0 min device use (raw data)
|
—
|
17 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 3 COWS score device use 30 min (raw data)
|
—
|
14 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 3 COWS score device use 60 min (raw data)
|
—
|
10 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 3 COWS score device use 120 min (raw data)
|
—
|
9 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 3 COWS score device use 2 days (raw data)
|
—
|
16 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 3 COWS score device use 3 days (raw data)
|
—
|
3 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 3 COWS score device use 4 days (raw data)
|
—
|
3 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 3 COWS score device use 5 days (raw data)
|
—
|
5 score on a scale
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 4 COWS score pre-device placement, 0 min device use (raw data)
|
16 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 4 COWS score device use 30 min (raw data)
|
8 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 4 COWS score device use 60 min (raw data)
|
6 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 4 COWS score device use 120 min (raw data)
|
5 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 4 COWS score device use 2 days (raw data)
|
4 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 4 COWS score device use 3 days (raw data)
|
6 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 4 COWS score device use 4 days (raw data)
|
5 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 4 COWS score device use 5 days (raw data)
|
3 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 5 COWS score pre-device placement, 0 min device use (raw data)
|
20 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 5 COWS score device use 30 min (raw data)
|
7 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 5 COWS score device use 60 min (raw data)
|
7 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 5 COWS score device use 120 min (raw data)
|
2 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 5 COWS score device use 2 days (raw data)
|
4 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 5 COWS score device use 3 days (raw data)
|
2 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 5 COWS score device use 4 days (raw data)
|
1 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 6 COWS score pre-device placement, 0 min device use (raw data)
|
16 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 6 COWS score device use 30 min (raw data)
|
11 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 6 COWS score device use 60 min (raw data)
|
10 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 6 COWS score device use 120 min (raw data)
|
8 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 6 COWS score device use 3 days (raw data)
|
8 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 6 COWS score device use 4 days (raw data)
|
9 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 6 COWS score device use 5 days (raw data)
|
4 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 5 COWS score device use 5 days (raw data)
|
0 score on a scale
|
—
|
|
Assess Change in Clinical Opiate Withdrawal Scale (COWS) Score
Subject 6 COWS score device use 2 days (raw data)
|
8 score on a scale
|
—
|
SECONDARY outcome
Timeframe: prior to device placement (0 min), 30 min, 60 min, 120 min, 2nd day, 3rd day, 4th day and 5th day of continuous device usePopulation: 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.
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.
Outcome measures
| Measure |
Bridge™ Active Device
n=3 Participants
The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Bridge™ active device: Bridge is a percutaneous nerve field stimulation device
|
Bridge™ Sham Device
n=3 Participants
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.
|
|---|---|---|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 1 SOWS score pre-device placement, 0 min device use (raw data)
|
—
|
40 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 1 SOWS score device use 30 min (raw data)
|
—
|
42 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 1 SOWS score device use 60 min (raw data)
|
—
|
NA score on a scale
score at this time point not obtained
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 1 SOWS score device use 120 min (raw data)
|
—
|
24 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 1 SOWS score device use 2 days (raw data)
|
—
|
38 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 1 SOWS score device use 3 days (raw data)
|
—
|
28 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 1 SOWS score device use 4 days (raw data)
|
—
|
19 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 1 SOWS score device use 5 days (raw data)
|
—
|
28 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 2 SOWS score pre-device placement, 0 min device use (raw data)
|
—
|
23 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 2 SOWS score device use 30 min (raw data)
|
—
|
10 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 2 SOWS score device use 60 min (raw data)
|
—
|
10 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 2 SOWS score device use 120 min (raw data)
|
—
|
10 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 2 SOWS score device use 2 days (raw data)
|
—
|
16 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 2 SOWS score device use 3 days (raw data)
|
—
|
19 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 2 SOWS score device use 4 days (raw data)
|
—
|
32 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 2 SOWS score device use 5 days (raw data)
|
—
|
34 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 3 SOWS score pre-device placement, 0 min device use (raw data)
|
—
|
46 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 3 SOWS score device use 30 min (raw data)
|
—
|
49 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 3 SOWS score device use 60 min (raw data)
|
—
|
35 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 3 SOWS score device use 120 min (raw data)
|
—
|
37 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 3 SOWS score device use 2 days (raw data)
|
—
|
43 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 3 SOWS score device use 3 days (raw data)
|
—
|
18 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 3 SOWS score device use 4 days (raw data)
|
—
|
9 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 3 SOWS score device use 5 days (raw data)
|
—
|
9 score on a scale
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 4 SOWS score pre-device placement, 0 min device use (raw data)
|
32 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 4 SOWS score device use 30 min (raw data)
|
12 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 4 SOWS score device use 60 min (raw data)
|
10 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 4 SOWS score device use 120 min (raw data)
|
9 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 4 SOWS score device use 2 days (raw data)
|
11 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 4 SOWS score device use 3 days (raw data)
|
11 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 4 SOWS score device use 4 days (raw data)
|
6 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 4 SOWS score device use 5 days (raw data)
|
5 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 5 SOWS score pre-device placement, 0 min device use (raw data)
|
47 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 5 SOWS score device use 30 min (raw data)
|
26 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 5 SOWS score device use 120 min (raw data)
|
14 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 5 SOWS score device use 2 days (raw data)
|
12 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 5 SOWS score device use 3 days (raw data)
|
10 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 5 SOWS score device use 4 days (raw data)
|
4 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 6 SOWS score pre-device placement, 0 min device use (raw data)
|
36 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 6 SOWS score device use 30 min (raw data)
|
25 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 6 SOWS score device use 60 min (raw data)
|
24 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 6 SOWS score device use 120 min (raw data)
|
19 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 6 SOWS score device use 2 days (raw data)
|
17 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 6 SOWS score device use 3 days (raw data)
|
11 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 6 SOWS score device use 4 days (raw data)
|
8 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 6 SOWS score device use 5 days (raw data)
|
6 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 5 SOWS score device use 60 min (raw data)
|
22 score on a scale
|
—
|
|
Assess Change in Subjective Opiate Withdrawal Scale (SOWS) Score
Subject 5 SOWS score device use 5 days (raw data)
|
4 score on a scale
|
—
|
Adverse Events
Bridge™ Active Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bridge™ Sham Device
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bridge™ Active Device
n=3 participants at risk
The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Bridge™ active device: Bridge is a percutaneous nerve field stimulation device
|
Bridge™ Sham Device
n=3 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Pain
|
0.00%
0/3 • Through end of study participation (approximately 3 weeks)
|
33.3%
1/3 • Number of events 1 • Through end of study participation (approximately 3 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60