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

Browse trials for

• Ischemic Stroke 2,653
• Hemiplegia 390

Ischemic Stroke

2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.

This study's planned enrollment of 80 is below the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 123 studies on the registry; 26 are open to participants now.

Study arms

• Active comparator
  Active Stimulation for right hemiparesis patients

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

  Device: transcutaneous auricular vagus nerve stimulation

• Sham comparator
  Sham Stimulation for right hemiparesis patients

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

  Device: Sham stimulation

• Active comparator
  Active Stimulation for left hemiparesis patients

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

  Device: transcutaneous auricular vagus nerve stimulation

• Sham comparator
  Sham Stimulation for left hemiparesis patients

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

  Device: Sham stimulation

Interventions

• Devicetranscutaneous auricular vagus nerve stimulation

  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.

• DeviceSham stimulation

  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 outcomes

1. 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).

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

2. 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.

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

Secondary outcomes

1. 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.

   Time frame: Change from Baseline Barthel Index at 4 weeks and 12 weeks

2. 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

   Time frame: Change from Baseline Modified Ashworth Scale at 4 weeks and 12 weeks

3. 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.

   Time frame: Change from Baseline Berg Balance Test at 4 weeks and 12 weeks

4. 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.

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

5. 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.

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