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

NCT05809037 | Unknown DMC

• 1 other identifier: 2022/382
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic; Hemiplegia; Hemiparesis;Poststroke/CVA

Outcome Measures

Primary Outcomes (2)

• 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).

  Change from Baseline Fugl-Meyer Assessment for Upper Extremity at 4 weeks and 12 weeks

• 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.

  Change from Baseline Stroke-Specific Quality of Life Scale at 4 weeks and 12 weeks

Secondary Outcomes (5)

• Barthel Index

  Change from Baseline Barthel Index at 4 weeks and 12 weeks

• Modified Ashworth Scale

  Change from Baseline Modified Ashworth Scale at 4 weeks and 12 weeks

• Berg Balance Test

  Change from Baseline Berg Balance Test at 4 weeks and 12 weeks

• Composite Autonomic Symptom Score (COMPASS-31)

  Change from Baseline Composite Autonomic Symptom Score at 4 weeks and 12 weeks

• Pittsburgh Sleep Quality Index

  Change from Baseline Pittsburgh Sleep Quality Index at 4 weeks and 12 weeks

Study Arms (4)

Active Stimulation for right hemiparesis patients

ACTIVE COMPARATOR

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

Device: transcutaneous auricular vagus nerve stimulation

Sham Stimulation for right hemiparesis patients

SHAM COMPARATOR

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

Device: Sham stimulation

Active Stimulation for left hemiparesis patients

ACTIVE COMPARATOR

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

Device: transcutaneous auricular vagus nerve stimulation

Sham Stimulation for left hemiparesis patients

SHAM COMPARATOR

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

Device: Sham stimulation

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

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.

Active Stimulation for left hemiparesis patients; Active Stimulation for right hemiparesis patients

Sham stimulation DEVICE

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.

Sham Stimulation for left hemiparesis patients; Sham Stimulation for right hemiparesis patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of subacute-chronic ischemic stroke (3-12 months)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selim Sezikli, MD

  Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selim Sezikli, MD

CONTACT

+902124965000; selimsezikli@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: March 27, 2023
• Primary Completion: December 27, 2023
• Study Completion: March 27, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

TU (1)