Health Condition 1: I639- Cerebral infarction, unspecified
Conditions
Interventions
Intervention1: Trans-auricular Vagus Nerve Stimulator: Active TaVNS –the neuro-stimulation will be delivered through a programmable TENS(Transcutaneous Electrical Nerve Stimulation)device. Route - Cus
Sponsors
Indian Council of Medical Research(ICMR)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Consenting male or female patients with history of supratentorial ischemic stroke. 2. History of Ischemic stroke occurred at least four months but no more than five years before enrollment. 3. Age range from 30 to 70 years. 4. Ability to grip a cylindrical object. 5. At least 10 degrees of wrist extension, 10 degrees of thumb abduction/extension, and at least 10 degrees of extension in at least two additional digits. 6. Patients with clinical history and neuroimaging evidence of ischemic stroke. 7. Features of residual post-stroke upper-limb motor impairment. 8. Features of post-stroke residual gait difficulty. 9. Ability to walk with or without support/assistive device for at least 6 metress at a stretch. 10. Patients on stable treatment regimen for the study duration. 11. Patients likely to comply with experimental protocols including neuro-stimulation and the rehabilitation programme. 12. Consenting study partner for helping the patients.
Exclusion criteria
Exclusion criteria: 1. Wheelchair bound or bed-ridden patients. 2. History of hemorrhagic stroke. 3. Significant sensory loss (using FMA-UE light tough and proprioception 4. Concomitant neurological diseases (tumour, epilepsy, demyelination, vascular Parkinsonism, vascular dementia etc.). 5. A history of more than two strokes. 6. Two strokes in two different hemispheres. 7. Patient having uncontrolled systemic disease including cardiac arrhythmia. 8. History of intolerance to neurostimulation therapy in the past. 9. Pregnant and lactating mothers. 10. Uncontrolled and severe depression and suicidal tendency. 11. Patients with global aphasia, hearing or visual impairment. 12. Prior or current history of alcohol abuse, or drug abuse. 13. Patient receiving any therapy that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms: nonselective/centrally acting anticholinergics, adrenergic blockers). 14. Patient with a history of and/or treated for cardiac arrythmia. 15. Patients with uncontrolled systemic disease. 16. Prior injury to vagus nerve. 17. Severe depression (Beck Depression Scale > 29). 18. Severe spasticity of the upper and lower limb (Modified Ashworth >3). 19. Severe spastic inversion of the foot.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the changes in hand function, gait, sleep and cognition between add-on TaVNS and sham for evaluation of efficacy and safety of TaVNS.Timepoint: 0 day, 14 days, 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the changes in electrophysiological biomarkers between add-on TaVNS and sham to understand the mechanism of TaVNSTimepoint: 0 day, 28 days;Compare the changes in molecular biomarkers between add-on TaVNS and sham to understand the mechanism of TaVNSTimepoint: 0 day, 28 days;Compare the reported adverse event frequency and other safety parameters between add-on TaVNS and sham for evaluation of efficacy and safety of TaVNSTimepoint: 0 day, 2 days, 4 days, 6 days, 14 days, 28 days | — |
Countries
India
Contacts
Public ContactDr Supriyo Choudhury
Institute of Neurosciences Kolkata
Outcome results
None listed