Trial Outcomes & Findings for Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage (NCT NCT04126408)
NCT ID: NCT04126408
Last Updated: 2024-01-09
Results Overview
Daily morphine equivalence dosage will be calculated and compared between the active and Sham group
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
up to 14 days of admission
Results posted on
2024-01-09
Participant Flow
Participant milestones
| Measure |
Sham Arm
gammaCore sham device which will not provide stimulation of the vagus nerve
gammaCore: The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.
|
Treatment Group
Active gammaCore device that supplies non-invasive stimulation of the cervical branch of the Vagus nerve
gammaCore: The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
Baseline characteristics by cohort
| Measure |
Active
n=19 Participants
active VNS group
|
Sham
n=21 Participants
sham group ( no real stimulation)
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Continuous
|
54 years
STANDARD_DEVIATION 13 • n=5 Participants
|
51 years
STANDARD_DEVIATION 11 • n=7 Participants
|
52.5 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
mfs
MFS1
|
4 participants
n=5 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
2 participants
n=7 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
6 participants
n=5 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
|
mfs
MFS2
|
1 participants
n=5 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
2 participants
n=7 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
3 participants
n=5 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
|
mfs
MFS3
|
8 participants
n=5 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
9 participants
n=7 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
17 participants
n=5 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
|
mfs
MFS4
|
6 participants
n=5 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
8 participants
n=7 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
14 participants
n=5 Participants • MODIFIED RANKIN SCALE IS A RANK FROM 1-4 1. MEANS THIN BLOOD WITH NO IVH 2. MEANS THIN BLOOD WITH IVH 3. MEANS THICK CLOOD WITH IVH 4. MEANS THICK BLOOD WITH IVH THE HIGHEST THE mFS the more blood there
|
|
HHS
hhs1
|
5 participants
n=5 Participants • 40 overall , 21 in sham and 19 in active
|
7 participants
n=7 Participants • 40 overall , 21 in sham and 19 in active
|
12 participants
n=5 Participants • 40 overall , 21 in sham and 19 in active
|
|
HHS
hhs2
|
10 participants
n=5 Participants • 40 overall , 21 in sham and 19 in active
|
11 participants
n=7 Participants • 40 overall , 21 in sham and 19 in active
|
21 participants
n=5 Participants • 40 overall , 21 in sham and 19 in active
|
|
HHS
hhs3
|
2 participants
n=5 Participants • 40 overall , 21 in sham and 19 in active
|
2 participants
n=7 Participants • 40 overall , 21 in sham and 19 in active
|
4 participants
n=5 Participants • 40 overall , 21 in sham and 19 in active
|
|
HHS
hhs4
|
2 participants
n=5 Participants • 40 overall , 21 in sham and 19 in active
|
1 participants
n=7 Participants • 40 overall , 21 in sham and 19 in active
|
3 participants
n=5 Participants • 40 overall , 21 in sham and 19 in active
|
PRIMARY outcome
Timeframe: up to 14 days of admissionPopulation: 4O PARTICIPANTS , 19 IN ACTIVE GROUP AND 21 IN SHAM GROUP
Daily morphine equivalence dosage will be calculated and compared between the active and Sham group
Outcome measures
| Measure |
Active Device
n=19 Participants
received stimulation
|
Sham
n=21 Participants
did not receive real stimulation
|
|---|---|---|
|
The Difference Between the Active and Sham Treatment Groups in Morphine Equivalence Dosage PER DAY
|
0.058 mg
Standard Deviation 0.31
|
0.24 mg
Standard Deviation 0.29
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PRIMARY outcome
Timeframe: baseline and 7 daysdifference in mean morphine equivalent dosage at 7 days between active and sham group
Outcome measures
| Measure |
Active Device
n=19 Participants
received stimulation
|
Sham
n=21 Participants
did not receive real stimulation
|
|---|---|---|
|
Overall Difference in MED at 7 Days
|
21.99 mg
Standard Deviation 21.41
|
24.29 mg
Standard Deviation 14.5
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SECONDARY outcome
Timeframe: up to 14 days of admissionPopulation: 40, 19 ACtIVE AND 21 SHAM
Headache intensity is measured every 4 hours per standard of care. The pain intensity is reported using a 0 to 10 numeric rating scale, o being no pain, and 10 being severe pain. least mean square difference between the 2 groups between the pre and post stimulation pain score
Outcome measures
| Measure |
Active Device
n=19 Participants
received stimulation
|
Sham
n=21 Participants
did not receive real stimulation
|
|---|---|---|
|
The Difference Between the Active and Sham Treatment Groups in the Mean Daily Headache Intensity Pre and Post Stimulation
|
-0.59 units on a scale
Standard Error 0.11
|
-0.13 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: up to 14 days of admissionPopulation: between sham and active hear rate
difference in change in Heart rate between the 2 groups from before to after stimulation
Outcome measures
| Measure |
Active Device
n=19 Participants
received stimulation
|
Sham
n=21 Participants
did not receive real stimulation
|
|---|---|---|
|
The Difference in Device Related Heart Rate Change Before and After Stimulation
|
-1.73 beats per min
Standard Error 1.13
|
-0.76 beats per min
Standard Error 1.18
|
SECONDARY outcome
Timeframe: before and after stimulation, up to 14 daysdifference between pre and post stimulation SBP between the 2 groups
Outcome measures
| Measure |
Active Device
n=19 Participants
received stimulation
|
Sham
n=21 Participants
did not receive real stimulation
|
|---|---|---|
|
Change in SBP Between Active and Sham Group
|
-2.20 millimeters of mercury
Standard Error 0.88
|
-1.64 millimeters of mercury
Standard Error 1.05
|
Adverse Events
Sham Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Treatment Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sham Arm
n=21 participants at risk
gammaCore sham device which will not provide stimulation of the vagus nerve
gammaCore: The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.
|
Treatment Group
n=19 participants at risk
Active gammaCore device that supplies non-invasive stimulation of the cervical branch of the Vagus nerve
gammaCore: The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.
|
|---|---|---|
|
General disorders
site discomfort
|
0.00%
0/21 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
31.6%
6/19 • Number of events 6 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
General disorders
tingling sensation
|
23.8%
5/21 • Number of events 5 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
47.4%
9/19 • Number of events 9 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
General disorders
pain at stimulation
|
9.5%
2/21 • Number of events 2 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
31.6%
6/19 • Number of events 6 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
General disorders
muscle twitching
|
9.5%
2/21 • Number of events 2 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
42.1%
8/19 • Number of events 8 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
General disorders
transient facial droop
|
0.00%
0/21 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
31.6%
6/19 • Number of events 6 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
Nervous system disorders
dizziness
|
0.00%
0/21 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
10.5%
2/19 • Number of events 2 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
Ear and labyrinth disorders
hoarseness
|
0.00%
0/21 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
0.00%
0/19 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
General disorders
dysgusia
|
0.00%
0/21 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
0.00%
0/19 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
General disorders
dyspnea
|
0.00%
0/21 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
5.3%
1/19 • Number of events 1 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/21 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
21.1%
4/19 • Number of events 4 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
|
Respiratory, thoracic and mediastinal disorders
coughing
|
0.00%
0/21 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
0.00%
0/19 • through study completion, up to 14 days
Difference in Heart rate, SBP, DBP between the active and sham between before and after stimulation rate of VNS related side effects: skin irritation, hoarseness, dyspepsia, shortness of breath , arrhythmia between the two groups
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place