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

July 23, 2023 updated by: Riphah International University

Additional Effects of Vagus Nerve Stimulation With Task-oriented Training on Motor Functions of Upper-limb in 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • KPK
      • Abbottabad, KPK, Pakistan, 22010
        • Women Institute of Rehabilitation Center and Jinnah international hospital, BBH
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irrij Jadoon, MS-NMPT*
        • Sub-Investigator:
          • Dr Abrish Abbasi, MS-NMPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  • Previous surgical intervention on vagus nerve
  • Severe pain in upper extremity
  • MoCA score of less than 10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vagus nerve stimulation with task oriented training
Other: 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.
Active Comparator: Task oriented training
Task oriented training alone
Other: Task oriented training
Task oriented group will receive task oriented training and placebo effect with vagus nerve stimulator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl Meyer Assessment Scale - Upper Extremity
Time Frame: 12 weeks
It is now widely used for clinical assessment of motor function. This is an impairment-based test with items organized by sequential recovery stages. A three-point ordinal scale is used to measure impairments of volitional movement with grades ranging from 0 (item cannot be performed) to 2 (item can be fully performed).Specific descriptions for performance accompany individual test items. Subtests exist for UE function, LE function, balance, sensation, ROM, and pain. The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., UE maximum score is 66, LE score 34; balance score 14). This instrument has good construct validity and high reliability (r 0.99) for determining motor function. Quantifiable outcome data allow this instrument to be accurately used for research purposes (a gold standard) and document recovery over time.
12 weeks
Wolf Motor Function Test (WMFT)
Time Frame: 12 weeks

Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. The original version consisted of 21 item; the widely used version of the WMFT consists of 17 items Composed of 3 parts:

  • Time
  • Functional ability
  • Strength Includes 15 function-based tasks and 2 strength based tasks Performance time is referred to as WMFT-TIME. Functional ability is referred to as WMFT-FAS. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. The WMFT is an instrument with high interrater reliability, internal consistency, test-retest reliability, and adequate stability
12 weeks
Box and Block Test (BBT)
Time Frame: 12 weeks

Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The test-retest reliability for the BBT was reported as excellent (ICC = 0.97; ICC = 0.96) for the right and left hand, respectively.

Inter-rater reliability for the BBT, as calculated using the ICC and Spearman rho correlation, was excellent (ICC = 0.99 and r = 0.99).
12 weeks
Nine Hole Peg Test (NHPT)
Time Frame: 12 weeks
Nine Hole Peg Test (NHPT) was developed to measure finger dexterity, also known as fine manual dexterity. It can be used with a wide range of populations, including clients with stroke. The NHPT is composed of a square board with 9 pegs. At one end of the board are holes for the pegs to fit in to, and at the other end is a shallow round dish to store the pegs. The NHPT is administered by asking the client to take the pegs from a container, one by one, and placing them into the holes on the board, as quickly as possible. Clients must then remove the pegs from the holes, one by one, and replace them back into the container.On average, healthy male adults complete the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy female adults, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hand, respectively.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Arshad Nawaz Malik, PhD, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2023

Primary Completion (Actual)

July 15, 2023

Study Completion (Actual)

July 15, 2023

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

March 15, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Irrij Javed Jadoon

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke (CVA) or TIA

Clinical Trials on Vagus nerve stimulation with task oriented training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe