In this mechanistic study, 40 individuals with chronic stroke will be implanted with a small vagus nerve stimulation (VNS) device. The study will use a randomized, blinded, crossover design to deliver two conditions in six-week blocks: active VNS or sham VNS, each paired with upper extremity (UE) motor rehabilitation. Assessment visits will occur before and after each block, and will examine neural pathway strength, functional connectivity, and motor and non-motor behaviors. Investigators will test for VNS-induced changes in motor, cognitive, and affective systems, and will identify biomarkers predictive of clinical response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
40
All patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers active VNS stimulation.
All patients will be implanted with the ReStore VNS device by an NYU neurosurgeon. During treatment sessions, study personnel will deliver a VNS burst at the completion of a training movement by pressing a button on a smart device, which wirelessly triggers sham VNS stimulation.
Rehabilitation training will be functional and activity-based, focusing on six task categories: reaching and grasping objects, gross movements with objects, flipping objects, inserting objects, self-feeding, and opening and closing containers. Three 90-minute training sessions per week will be administered by a licensed occupational therapist, over two six-week treatment blocks. Sessions will be paired with either active or sham VNS administration.
NYU Langone Health
New York, New York, United States
RECRUITINGThe University of Texas at Dallas
Richardson, Texas, United States
RECRUITINGPercent change in Ipsilesional CST MEP Size after Active VNS
Ipsilesional corticospinal tract (CST) motor evoked potential (MEP) size measured before and after the treatment block.
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent change in Ipsilesional CST MEP Size after Sham VNS
Ipsilesional corticospinal tract (CST) motor evoked potential (MEP) size measured before and after the treatment block.
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent change in Ipsilesional CReST MEP Size after Active VNS
Ipsilesional corticoreticulospinal tract (CReST) motor evoked potential (MEP) size measured before and after the treatment block.
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent change in Ipsilesional CReST MEP Size after Sham VNS
Ipsilesional corticoreticulospinal tract (CReST) motor evoked potential (MEP) size measured before and after the treatment block.
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent Change in Arm Strength after Active VNS
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent Change in Arm Strength after Sham VNS
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent Change in Motor Control after Active VNS
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent Change in Motor Control after Sham VNS
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
Percent Change in Individuation after Active VNS
Time frame: Pre-Active VNS Treatment Block (Week 0 [Arm 1] or Week 6 [Arm 2]), Post-Active VNS Treatment Block (Week 6 [Arm 1] or Week 12 [Arm 2])
Percent Change in Individuation after Sham VNS
Time frame: Pre-Sham VNS Treatment Block (Week 0 [Arm 2] or Week 6 [Arm 1]), Post-Sham VNS Treatment Block (Week 6 [Arm 2] or Week 12 [Arm 1])
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