Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits

Korábbi kezelés

• Botox injections 12 weeks prior to or during therapy
• Participants who have had a craniectomy:
  • Without replacement of bone flap
  • With bone flap replaced < 6 months prior to initiation of study activities

Más betegség

• Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous
• Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease
• Participant has a fever or shows clinical signs concerning for an infectious disease
• Other neurologic or musculoskeletal diseases that could interfere with the assessments of this study
• Low heart rate (<60 bpm) from a cardiac conduction block or related etiology
• Participant has a history of trigeminal neuralgia
• Participant has a history of Bell's Palsy
• History of cranial nerve neuropathy (including facial nerve injury), carotid surgery, vagotomy, or other surgical intervention on the vagus nerve
• History of recurrent syncopal events
• Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days

Egyéb

• Participant with any implanted metallic device at or near the stimulation sites (forehead and ears).
• Participant with an implanted or active stimulator (ex. Deep brain stimulator, pacemaker, vagus nerve stimulator, defibrillator)
• Known or newly-discovered aneurysm or arteriovenous malformation

• History of unilateral supratentorial ischemic, intracerebral hemorrhagic, subarachnoid hemorrhagic, or a heterogeneous lesion stroke that occurred at least 6 months but not more than 15 years prior to enrollment.
• Age >30 years and <85 years.
• Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 10 to 56 (inclusive of 10 and 56).
• Ability to communicate, understand, and provide appropriate consent. Subjects should be able to follow two-step commands.
• Right- or left-sided weakness of the upper extremity.