Clinical trial NCT05809037: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Hemiplegia
Hemiparesis;Poststroke/CVA
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fugl-Meyer Assessment for Upper Extremity
timeFrame: Change from Baseline Fugl-Meyer Assessment for Upper Extremity at 4 weeks and 12 weeks
measure: Stroke-Specific Quality of Life Scale
timeFrame: Change from Baseline Stroke-Specific Quality of Life Scale at 4 weeks and 12 weeks
Secondary outcomes:
measure: Barthel Index
timeFrame: Change from Baseline Barthel Index at 4 weeks and 12 weeks
measure: Modified Ashworth Scale
timeFrame: Change from Baseline Modified Ashworth Scale at 4 weeks and 12 weeks
measure: Berg Balance Test
timeFrame: Change from Baseline Berg Balance Test at 4 weeks and 12 weeks
measure: Composite Autonomic Symptom Score (COMPASS-31)
timeFrame: Change from Baseline Composite Autonomic Symptom Score at 4 weeks and 12 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from Baseline Pittsburgh Sleep Quality Index at 4 weeks and 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training and research Hospital
Study officials:
affiliation: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
name: Selim Sezikli, MD
role: PRINCIPAL_INVESTIGATOR
References: