Vivistim Registry for Paired VNS Therapy (GRASP)

Conditions

• Upper Extremity Problem

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vivistim System — DEVICE
  VNS Paired with rehabilitation movements

Study Details

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.

Key Dates

Start date

Mar 15, 2023

Status verified

May 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

1,000 participants (estimated)

Primary Outcome Measure

Fugl Meyer Assessment (FM-A) [ Time Frame: 6 months ]

Central Contacts

• Brent Tarver, BSEE
  8556289375
  [email protected]
• Diana Hansen
  8556289375
  [email protected]

Locations (15)

Find similar trials in Orlando, FL

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