search
Back to results

Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke

Primary Purpose

Stroke, Ischemic, Hemiplegia, Hemiparesis;Poststroke/CVA

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
transcutaneous auricular vagus nerve stimulation
Sham stimulation
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: History of subacute-chronic ischemic stroke (3-12 months) Exclusion Criteria: Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy). Severe depression (Beck Depression Scale > 29) Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline. Pregnancy or planning to become pregnant or breastfeed during the study period. Botox injections or hemiplegia rehabilitation within 6 months before treatment. Having a history of hemorrhagic stroke Presence of ongoing dysphagia or aspiration difficulties.

Sites / Locations

  • Istanbul Physical Medicine and Rehabilitation Training and research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

Active Stimulation for right hemiparesis patients

Sham Stimulation for right hemiparesis patients

Active Stimulation for left hemiparesis patients

Sham Stimulation for left hemiparesis patients

Arm Description

Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis

Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis

Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis

Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment for Upper Extremity
It is considered as gold standard and is the only impairment level measure recommended for stroke trials. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).
Stroke-Specific Quality of Life Scale
The Stroke-Specific Quality of Life Scale assesses health-related quality of life specific to stroke survivors. 49 questions under 12 subscales. Scores range from 49-245. Higher scores indicate better functioning.

Secondary Outcome Measures

Barthel Index
Barthel Index is used to measure the disability experienced by the patient in performing activities of daily living. It comprises 10 items regarding activities of daily living and mobility and assesses feeding, transfer from wheelchair to bed and back, self-care, bathing, walking, climbing stairs, dressing, and bladder and bowel continence. Scoring is based on whether the patient requires help or not in performing any of the above mentioned activities. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.
Modified Ashworth Scale
Modified Ashworth Scale (MAS) is used to assess spasticity. Scoring: 0: No increase in tone; 1: slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension; 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ); 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed; 3: considerable increase in tone, passive movement difficult and, 4: limb rigid in flexion or extension
Berg Balance Test
Berg Balance Test is consisting of 14 items and measures the ability of individuals to maintain balance while performing functional tasks. Each task is scored from 0 (cannot perform independently) to 4 (stated best performance). 0-20 points are interpreted as high risk of falling, between 21-40 points as medium risk of falling, and between 41-56 points as low risk.
Composite Autonomic Symptom Score (COMPASS-31)
The test has 6 domains looking at autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. The six domain scores sum to a total COMPASS 31 score of 0 to 100, and a higher COMPASS 31 score indicates more severe autonomic symptoms.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Full Information

First Posted
March 30, 2023
Last Updated
April 11, 2023
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05809037
Brief Title
Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke
Official Title
Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
December 27, 2023 (Anticipated)
Study Completion Date
March 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study, the effectiveness of vagus nerve stimulation in patients with right and left hemiparesis will be compared with each other and with the sham application.
Detailed Description
This prospective study will include 80 participants with a diagnosis of ischemic stroke who meet the inclusion criteria. In addition to the conventional rehabilitation program, non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, noninvasive auricular stimulation will be applied, stimulation frequency is 10 Hz, the pulse width is 300 µs, biphasic. In the study, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. The study will be completed when the evaluation of the participants is made in the 1st and 3rd months after the last intervention. The upper extremity functions of the patients participating in the study were determined by Fugl-Meyer upper extremity test and box and block test, upper and lower extremity spasticities by modified Ashworth scale, and sleep quality by Pittsburgh sleep quality index. Quality of life will be evaluated with the stroke-specific quality of life scale, balance functions with the Berg balance test, dependency levels in daily activities with the Barthel index, and sympathetic dysfunctions with COMPASS-31. Participants' blood pressure and pulse values will be evaluated before and after each session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Hemiplegia, Hemiparesis;Poststroke/CVA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Stimulation for right hemiparesis patients
Arm Type
Active Comparator
Arm Description
Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis
Arm Title
Sham Stimulation for right hemiparesis patients
Arm Type
Sham Comparator
Arm Description
Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke right hemiparesis
Arm Title
Active Stimulation for left hemiparesis patients
Arm Type
Active Comparator
Arm Description
Active non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis
Arm Title
Sham Stimulation for left hemiparesis patients
Arm Type
Sham Comparator
Arm Description
Sham non-invasive transauricular vagus nerve stimulation over left ear in post-stroke left hemiparesis
Intervention Type
Device
Intervention Name(s)
transcutaneous auricular vagus nerve stimulation
Intervention Description
In addition to the conventional rehabilitation program, non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, noninvasive auricular stimulation will be applied, stimulation frequency is 10 Hz, pulse width is 300 µs, and biphasic.
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
In addition to the conventional rehabilitation program, sham vagus nerve stimulation (0 mA) will be applied to the participants in the control group. Non-invasive vagus nerve stimulation will be applied to the participants through the left ear with the Vagustim™-Ear tens electrode. As a vagus stimulation protocol, 10 sessions, 30 minutes, and noninvasive auricular stimulation will be applied.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment for Upper Extremity
Description
It is considered as gold standard and is the only impairment level measure recommended for stroke trials. It consists of 30 items assessing motor function and 3 items assessing reflex function. The score most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).
Time Frame
Change from Baseline Fugl-Meyer Assessment for Upper Extremity at 4 weeks and 12 weeks
Title
Stroke-Specific Quality of Life Scale
Description
The Stroke-Specific Quality of Life Scale assesses health-related quality of life specific to stroke survivors. 49 questions under 12 subscales. Scores range from 49-245. Higher scores indicate better functioning.
Time Frame
Change from Baseline Stroke-Specific Quality of Life Scale at 4 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Barthel Index
Description
Barthel Index is used to measure the disability experienced by the patient in performing activities of daily living. It comprises 10 items regarding activities of daily living and mobility and assesses feeding, transfer from wheelchair to bed and back, self-care, bathing, walking, climbing stairs, dressing, and bladder and bowel continence. Scoring is based on whether the patient requires help or not in performing any of the above mentioned activities. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.
Time Frame
Change from Baseline Barthel Index at 4 weeks and 12 weeks
Title
Modified Ashworth Scale
Description
Modified Ashworth Scale (MAS) is used to assess spasticity. Scoring: 0: No increase in tone; 1: slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension; 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ); 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed; 3: considerable increase in tone, passive movement difficult and, 4: limb rigid in flexion or extension
Time Frame
Change from Baseline Modified Ashworth Scale at 4 weeks and 12 weeks
Title
Berg Balance Test
Description
Berg Balance Test is consisting of 14 items and measures the ability of individuals to maintain balance while performing functional tasks. Each task is scored from 0 (cannot perform independently) to 4 (stated best performance). 0-20 points are interpreted as high risk of falling, between 21-40 points as medium risk of falling, and between 41-56 points as low risk.
Time Frame
Change from Baseline Berg Balance Test at 4 weeks and 12 weeks
Title
Composite Autonomic Symptom Score (COMPASS-31)
Description
The test has 6 domains looking at autonomic symptoms: orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder and pupillomotor. The six domain scores sum to a total COMPASS 31 score of 0 to 100, and a higher COMPASS 31 score indicates more severe autonomic symptoms.
Time Frame
Change from Baseline Composite Autonomic Symptom Score at 4 weeks and 12 weeks
Title
Pittsburgh Sleep Quality Index
Description
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Time Frame
Change from Baseline Pittsburgh Sleep Quality Index at 4 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of subacute-chronic ischemic stroke (3-12 months) Exclusion Criteria: Bilateral or unilateral previous injury to the vagus nerve (eg injury during carotid endarterectomy). Severe depression (Beck Depression Scale > 29) Current use of any other stimulation device, such as a pacemaker or other neurostimulator; current use of any other investigational device or drug. Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from following the protocol timeline. Pregnancy or planning to become pregnant or breastfeed during the study period. Botox injections or hemiplegia rehabilitation within 6 months before treatment. Having a history of hemorrhagic stroke Presence of ongoing dysphagia or aspiration difficulties.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Selim Sezikli, MD
Phone
+902124965000
Email
selimsezikli@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selim Sezikli, MD
Organizational Affiliation
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine and Rehabilitation Training and research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selim Sezikli, MD
Phone
+902124965000
Email
selimsezikli@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Noninvasive Vagus Nerve Stimulation on Functional Status in Ischemic Stroke

We'll reach out to this number within 24 hrs