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

Stroke (CVA) or TIA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05771805
• Other study ID #: Irrij Javed Jadoon
• Status: Completed
• Phase: N/A
• Start date: March 25, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: July 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke (CVA) or TIA

Intervention

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

Locations

Country	Name	City	State
Pakistan	Women Institute of Rehabilitation Center and Jinnah international hospital, BBH	Abbottabad	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment Scale - Upper Extremity	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
Primary	Wolf Motor Function Test (WMFT)	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
Primary	Box and Block Test (BBT)	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
Primary	Nine Hole Peg Test (NHPT)	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