Additional Effects of Vagus Nerve Stimulation on Motor Functions of Upper-limb in Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-25

Study Completion Date

2023-07-15

Brief Summary

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The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke

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Detailed Description

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Stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours or leading to death with no apparent cause. Nerve stimulation paired with rehabilitation is a novel potential treatment option for people with long-term moderate-to-severe arm impairment after stroke. The study aims to determine the additional effects of vagus nerve stimulation with task-oriented training on motor functions of upper-limb in stroke. The idea of stimulating the vagus nerve to modify central brain activity has been pursued. Vagus nerve stimulation (VNS) paired with rehabilitative training enhances recovery of function in models of stroke and is currently under investigation for use in chronic stroke patients. Compared to traditional stimulation, noninvasive VNS seems to be safer and more tolerable.

Conditions

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Stroke (CVA) or TIA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vagus nerve stimulation with task oriented training

Group Type EXPERIMENTAL

Vagus nerve stimulation with task oriented training

Intervention Type OTHER

VNS Group will receive non-invasive vagus nerve stimulation at left auricle of ear for 30 mins during the task-oriented training. Subjects will receive protocol 3 days per week for 12 weeks.

Task oriented training

Task oriented training alone

Group Type ACTIVE_COMPARATOR

Task oriented training

Intervention Type OTHER

Task oriented group will receive task oriented training and placebo effect with vagus nerve stimulator.

Interventions

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Vagus nerve stimulation with task oriented training

VNS Group will receive non-invasive vagus nerve stimulation at left auricle of ear for 30 mins during the task-oriented training. Subjects will receive protocol 3 days per week for 12 weeks.

Intervention Type OTHER

Task oriented training

Task oriented group will receive task oriented training and placebo effect with vagus nerve stimulator.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Sub-Acute stroke (3 months to 6 months)
* Between grade 0 and grade 2 on modified Ashworth scale.
* Patients who will be able to walk without assisted devices and can stand for 2 minutes.
* Either type Ischemic or Hemorrhagic
* Age bracket 40-60 Years