Trial Outcomes & Findings for Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB) (NCT NCT03131960)
NCT ID: NCT03131960
Last Updated: 2022-07-20
Results Overview
The Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for difference in average change at 1-day after 6-weeks of therapy compared to baseline (Difference in average change in FM-A from baseline \[V4\] to one day after therapy \[V5\]). The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
V5, One day after 6-weeks of therapy
Results posted on
2022-07-20
Participant Flow
Participant milestones
| Measure |
VNS + Rehabilitation (1)
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Control VNS
Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
55
|
|
Overall Study
COMPLETED
|
53
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
VNS + Rehabilitation (1)
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Control VNS
Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Pivotal Study of VNS During Rehab After Stroke (VNS-REHAB)
Baseline characteristics by cohort
| Measure |
VNS + Rehabilitation (1)
n=53 Participants
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Control VNS
n=55 Participants
Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Total
n=108 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
|
30 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
FMA-UE Baseline Score
|
34.4 units on a scale
STANDARD_DEVIATION 8.2 • n=5 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 7.8 • n=7 Participants
|
35.1 units on a scale
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
WMFT Baseline Score
|
2.71 units on a scale
STANDARD_DEVIATION 0.70 • n=5 Participants
|
2.83 units on a scale
STANDARD_DEVIATION 0.65 • n=7 Participants
|
2.76 units on a scale
STANDARD_DEVIATION 0.67 • n=5 Participants
|
PRIMARY outcome
Timeframe: V5, One day after 6-weeks of therapyThe Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for difference in average change at 1-day after 6-weeks of therapy compared to baseline (Difference in average change in FM-A from baseline \[V4\] to one day after therapy \[V5\]). The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Outcome measures
| Measure |
VNS + Rehabilitation (1)
n=53 Participants
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Control VNS
n=55 Participants
Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
|---|---|---|
|
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change
|
5.0 units on a scale
Standard Deviation 4.4
|
2.4 units on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: V7, 90 days after 6-weeks of therapyThe Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for change in average score at 90-days after 6-weeks of therapy (change in average FMA-UE from baseline \[V4\] to 90 days after therapy \[V7\]). The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Outcome measures
| Measure |
VNS + Rehabilitation (1)
n=53 Participants
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Control VNS
n=55 Participants
Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
|---|---|---|
|
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change
|
5.8 units on a scale
Standard Deviation 6.0
|
2.8 units on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: V7, 90 days after 6-weeks of therapyThe Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response is the percent of patients with a 6 point or greater improvement on the (FMA-UE). The percent of patients with the 6-point change is calculated at 90-days after 6-weeks of therapy compared to baseline (V4). The upper extremity portion of the Fugl-Meyer Assessment (FMA-UE) was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Outcome measures
| Measure |
VNS + Rehabilitation (1)
n=53 Participants
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Control VNS
n=55 Participants
Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
|---|---|---|
|
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response
|
25 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: V7, 90 days after 6-weeks of therapyThe Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal). WMFT 90-day - is a measure of the functional assessment change from baseline to 90 days after 6-weeks of therapy.
Outcome measures
| Measure |
VNS + Rehabilitation (1)
n=53 Participants
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Control VNS
n=55 Participants
Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) Average Change
|
0.46 units on a scale
Standard Deviation 0.40
|
0.16 units on a scale
Standard Deviation 0.30
|
Adverse Events
VNS + Rehabilitation (1)
Serious events: 5 serious events
Other events: 43 other events
Deaths: 0 deaths
Control VNS
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VNS + Rehabilitation (1)
n=53 participants at risk
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Control VNS
n=55 participants at risk
Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
|---|---|---|
|
Nervous system disorders
Seizure
|
1.9%
1/53 • Number of events 1 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
0.00%
0/55 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Renal and urinary disorders
Acute Kidney Injury (AKI)/ chronic kidney disease (CKD)
|
0.00%
0/53 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Renal and urinary disorders
Urinary Tract Infection (UTI)
|
1.9%
1/53 • Number of events 1 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
0.00%
0/55 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Injury, poisoning and procedural complications
Dysphonia
|
0.00%
0/53 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Injury, poisoning and procedural complications
Fall
|
3.8%
2/53 • Number of events 2 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
1.8%
1/55 • Number of events 1 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Gastrointestinal disorders
Colinic Diverticular Abscess
|
1.9%
1/53 • Number of events 1 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
0.00%
0/55 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
Other adverse events
| Measure |
VNS + Rehabilitation (1)
n=53 participants at risk
Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation.
Paired Vagus Nerve Stimulation: Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
Control VNS
n=55 participants at risk
Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.
Rehabilitation: Rehabilitation movements to improve upper limb function after stroke
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.8%
2/53 • Number of events 2 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
12.7%
7/55 • Number of events 7 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
General disorders
Pain
|
9.4%
5/53 • Number of events 5 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
12.7%
7/55 • Number of events 7 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Injury, poisoning and procedural complications
Coughing/Hoarseness
|
15.1%
8/53 • Number of events 8 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
18.2%
10/55 • Number of events 10 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Nervous system disorders
Dizziness
|
5.7%
3/53 • Number of events 3 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
5.5%
3/55 • Number of events 3 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Psychiatric disorders
Low Mood
|
9.4%
5/53 • Number of events 5 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
7.3%
4/55 • Number of events 4 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Injury, poisoning and procedural complications
Bruise
|
15.1%
8/53 • Number of events 8 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
7.3%
4/55 • Number of events 4 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
3/53 • Number of events 3 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
0.00%
0/55 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
General disorders
Fatigue
|
5.7%
3/53 • Number of events 3 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
3.6%
2/55 • Number of events 2 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Injury, poisoning and procedural complications
Local Throat Irritation
|
5.7%
3/53 • Number of events 3 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
5.5%
3/55 • Number of events 3 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
|
Vascular disorders
Headache
|
5.7%
3/53 • Number of events 3 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
3.6%
2/55 • Number of events 2 • Adverse events were collected over the course of the randomized study (enrollment, 4-week baseline, implant, 2-week recover, 6-week therapy, 90-day follow-up) and reported here.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place