Health TrialsbyHealthPanel

Impact of VNS With Rehab on Gait Post-Stroke

ConditionsUpper Limb DeficitStroke Gait RehabilitationStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-80
SponsorState University of New York at Buffalo

About this trial

This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy

≥22 years and ≤ 80 years

Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits

Residual active movement in the affected limb's thumb and other 2 fingers

Disqualifiers

Intact lower limb functions (Fugl-Meyer score=34)

Not a candidate for VNS therapy according to FDA guidelines

Pregnant patients

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vagus Nerve Stimulation Therapy

    Device

    Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: VNS ONExperimental treatment 1 intervention
Group B: VNS OFFSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale

Absolute change in FMA-LE from baseline to 90 days

Time frame
90 days post-operation
2

Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale

Percent change in FMA-LE from baseline to 90 days

Time frame
90 days post-operation

Secondary outcomes

1

Absolute Change in Functional Assessment - 10-meter walk

Absolute change in gait function as assessed by the timed 10-meter walk from baseline to 90 days

Time frame
90 days post-operation
2

Percent Change in Functional Assessment - 10-meter walk

Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days

Time frame
90 days post-operation
3

Absolute Change in Functional Assessment - 6-minute walk

Absolute change in gait function as assessed by the 6-minute walk from baseline to 90 days

Time frame
90 days post-operation
4

Percent Change in Functional Assessment - 6-minute walk

Percent change in gait function as assessed by the 6-minute walk from baseline to 90 days

Time frame
90 days post-operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

State University of New York at Buffalo

Lead sponsor

Source ClinicalTrials.gov
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