Adults 22 to 80, any sex, with Cerebrovascular Stroke or Upper Extremity Paresis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average ChangePrimary· V5, One day after 6-weeks of therapy
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).
Group
Value
95% CI
VNS + Rehabilitation (1)
5.0
± 4.4
Control VNS
2.4
± 3.8
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average ChangeSecondary· V7, 90 days after 6-weeks of therapy
The 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).
Group
Value
95% CI
VNS + Rehabilitation (1)
5.8
± 6.0
Control VNS
2.8
± 5.2
Fugl-Meyer Assessment, Upper Limb (FMA-UE) ResponseSecondary· V7, 90 days after 6-weeks of therapy
The 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).
Group
Value
95% CI
VNS + Rehabilitation (1)
25
Control VNS
13
Wolf Motor Function Test (WMFT) Average ChangeSecondary· V7, 90 days after 6-weeks of therapy
The 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.
Group
Value
95% CI
VNS + Rehabilitation (1)
0.46
± 0.40
Control VNS
0.16
± 0.30
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment. The randomization will be stratified by age (\<30, \>30) and baseline FMA UE (20 to \<35; \>35 to 50). Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. 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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MicroTransponder Inc.
Last refreshed: 20 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03131960.