An interventional study of Active-VNS and Sham VNS in Spontaneous Intracerebral Hemorrhage, Motor Function and Upper Extremity Injury, sponsored by First Affiliated Hospital of Fujian Medical University. Not yet recruiting. Open to participants aged 22 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by First Affiliated Hospital of Fujian Medical University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to investigate the efficacy and safety of vagus nerve stimulation (VNS) combined with rehabilitation in improving upper extremity motor function after spontaneous intracerebral hemorrhage (ICH).
Researchers will evaluate the efficacy and safety of VNS by comparing the improvements of arm motor function post-ICH in the active VNS combined rehabilitation group with that in the sham VNS combined rehabilitation group (actual intensity 0 mA).
Participants in this study will undergo a surgical procedure to implant the VNS system and will subsequently recieve a 6 weeks in-clinic therapy, followed by an additional 6 weeks home exercise. During the final 6 weeks, participants will either recieve in-clinic therapy or maintain their home exercise, depending on their assigned group.
There are 6 follow-up timepoints in this trial:
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's planned enrollment of 10 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.
Browse Cerebral Hemorrhage studies →First Affiliated Hospital of Fujian Medical University is the lead sponsor of 92 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active VNS paired with rehabilitation Device: VNS A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve. Other: Rehabilitation Rehabilitation movements to improve upper limb function after stroke.
Device: Active-VNS
Sham VNS paired with rehabilitation Device: Sham VNS A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA. Other: Rehabilitation Rehabilitation movements to improve upper limb function after stroke.
Device: Sham VNS
A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve.
A neuromodulation treatment that delivers electrical impulses to the brain via the vagus nerve, the actual intensity is 0 mA.
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change
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). The FMA-UE will be analyzed for difference in average change at Clinic rehabilitation follow-up timepoint compared to Baseline follow-up timepoint (Difference in average change in FMA-UE from V3 to V4).
Time frame: V4, 6 weeks after baseline follow-up timepoint
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response
The Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Response is the percent of patients with a 6 point or greater improvement on the FMA-UE.
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint
Upper Extremity Motor Section of the Fugl-Meyer Assessment (FMA-UE) Average Change
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).
Time frame: V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Wolf Motor Function Test (WMFT) Average Change
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).
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Wolf Motor Function Test (WMFT) Response
Wolf Motor Function Test (WMFT) Response is the percent of patients with a 0.4 point or greater improvement on the WMFT.
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint
EQ-5D-3L Average Change
The EQ-5D-3L is a general measure of health outcomes in any population. It is a self-report questionnaire which provides a simple descriptive profile and a single index value for health status.
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
Incidence of Adverse Events
The incidence of adverse events occurred during the clinical trial, whether or not related to the device.
Time frame: V4, 6 weeks after Baseline follow-up timepoint; V5, 6 weeks after Clinic rehabilitation follow-up timepoint; V6, 6 weeks after Home exercise follow-up timepoint
No study locations are listed for this record.
Plan to share: Undecided — Deidentified case data are available from the authors upon reasonable request, after request in writing to the corresponding authors and after approval by the study committee and principal investigators from each site.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Fujian Medical University