NCT04534556Enrolling by invitation
Wireless Nerve Stimulation Device To Enhance Recovery After Stroke
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
Texas Biomedical Device Center (TxBDC) has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Preclinical findings demonstrate that VNS paired with rehabilitative training enhances recovery in multiple models of neurological injury, including stroke, spinal cord injury, intracerebral hemorrhage, and traumatic brain injury. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, two initial studies and a recently completed Phase 3 clinical trial using a commercially available device demonstrates that paired VNS with rehabilitation is safe and improves motor recovery after stroke. The purpose of this study is to extend these findings and evaluate whether VNS delivered with the new device paired with rehabilitation represents a safe and feasible strategy to improve recovery of motor and sensory function in participants with stroke.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 18 Aug 2020
- Start date
- 24 Sept 2021
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Baylor Research Institute
- Diseases
- Stroke
- NCT number
- NCT04534556
What you commit to
- Study type: Interventional
- Planned participants: 42
- From 24 Sept 2021 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)
- Prior injury to vagus nerve
- Clinical complications that hinder or contraindicate the surgical procedure
Other illness
- Participants with sickle cell, lupus, clotting disorders or active neoplastic disease.
- Participants with any any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
- Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
- Recent history of syncope
- Recent history of dysphagia
- Uncontrolled hypertension
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Deficits in language or attention that interfere with study participation
- Severe spasticity (Modified Ashworth ≥ 3)
- Medical or mental instability that would likely interfere with study protocol
- Presence of any other implanted electrical stimulation device
- Lactating, pregnant, or plan to become pregnant
- Participation in another interventional clinical trial
- Abusive use of alcohol and/or illegal substances use
- Current or anticipated requirement for diathermy
- Diagnosed with Cerebral amyloid angiopathy
Who the study is looking for
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Adult, aged 22-79
- Ischemic or hemorrhagic stroke that occurred ≥ 12 months prior to enrollment
- UEFM score of 20 to 50
- Modified Rankin Score of 2, 3, or 4
- Right vocal cord has normal movement when assessed by laryngoscopy
- Women of reproductive potential must use contraceptive protection
- Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist
Age in the registry: 22 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor Scott & White Institute for Rehabilitation Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.