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The study was terminated because the investigational device could no longer be provided for study purposes, precluding further trial conduct.
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| The University of Texas at Dallas | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active VNS first, then Sham VNS | Experimental | Patients will undergo two 6-week intervention blocks, receiving active VNS first and sham VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with active VNS during the first block and paired with sham VNS during the second block. |
|
| Sham VNS first, then Active VNS | Experimental | Patients will undergo two 6-week intervention blocks, receiving sham VNS first and active VNS second. Blocks consist of three 90-minute sessions per week with a licensed occupational therapist (OT). During these sessions, patients will perform rehabilitation training activities paired with sham VNS during the first block and paired with active VNS during the second block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus Nerve Stimulation (VNS) Device | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent 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. | 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. | 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]) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Schambra, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States | ||
| The University of Texas at Dallas |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Heidi.schambra@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Heidi.schambra@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 23, 2025 | Jun 10, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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|
| Sham VNS Device | Device | 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. |
|
| Upper Extremity Rehabilitation | Behavioral | 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. |
|
| 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. |
| 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 | 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 | 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 | 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 | 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 | 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 | 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]) |
| Richardson |
| Texas |
| 75080 |
| United States |