Vivistim Registry for Paired VNS Therapy (GRASP)
ConditionUpper Extremity Problem
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorMicroTransponder Inc.
About this trial
The purpose of the Vivistim Registry for Paired VNS Therapy (GRASP) is to gather real-world information on patients with arm and hand deficits post-stroke who are considering Vivistim System treatment. Before and after Vivistim System implant, patient data will be collected and reported throughout the therapy process. Physicians or sites will receive appropriate remuneration for the effort and cost involved in collecting and transmitting this data to MicroTransponder Inc.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke
Disqualifiers
Not eligible for surgery
Trial population
Ischemic stroke patients implanted with the Vivistim System
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Vivistim System
DeviceVNS Paired with rehabilitation movements
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Fugl Meyer Assessment (FM-A)
Change in Fugl Meyer Assessment score
Time frame
6 months2
Wolf Motor Function Test (WMFT)
Change in Wolf Motor Function Test score
Time frame
6 monthsSecondary outcomes
1
Stroke Impact Scale (SIS)
Change in Stroke Impact Scale
Time frame
6 months2
Motor Activity Log (MAL)
Change in Motor Activity Log
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov