Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischemic Stroke
Condition: Acute Ischaemic Stroke; Autonomic Dysfunction
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Autonomic Nervous System Diseases; Primary Dysautonomias; Ischemia
Study type: Interventional

Summary: 
      This explorative prospective study aims to assess the effects of heart rate variability
      biofeedback (HRV biofeedback) in patients with acute ischaemic stroke. Furthermore, the
      investigators aim to examine the impact of the intervention on cardiac autonomic function and
      further autonomic parameters such as sudomotor (sympathetic perspiratory gland function) and
      vasomotor function (sympathetic arterial function). Patients testing is going to be conducted
      at the Department of Neurology, University Hospital Carl Gustave Carus, Dresden, Germany.
    

Detailed description: 
      Background:

      Ischaemic stroke is among the most common causes for severe disability and death in the
      industrialized world with steadily increasing prevalence due to the demographic change. Thus
      more than 795,000 people yearly have a stroke in the United States of America, of which circa
      610,000 people have new strokes or a stroke for the first time in their life (Benjamin, et
      al. 2017). Symptoms of ischaemic stroke patients include dysregulation of the autonomic
      nervous system such as cardiac and vascular autonomic dysfunction, which correlate with
      increased mortality and poor functional outcome. This study aims to assess the effects of
      heart rate variability biofeedback (HRV-Biofeedback) in patients with acute ischaemic stroke.
      Furthermore, the investigators aim to examine the impact of the intervention on cardiac
      autonomic function and further autonomic parameters such as sudomotor (sympathetic
      perspiratory gland function) and vasomotor function (sympathetic arterial function).

      Methods/design:

      An explorative prospective study is undertaken in 48 patients with acute ischaemic stroke who
      undergo either 9 x 10-minutes lasting biofeedback sessions over a period of 3 days, or
      sham-biofeedback (control-group) also over a period of 3 days under randomized controlled
      conditions.

      The HRV-biofeedback technique is based on the recording and visualization of heart rate
      variability, which is visible in real-time for the patient on a computer screen. In the
      training sessions, the patient is instructed to breath in a predefined frequency, which has
      been shown to yield optimal neurologic-cardiac regulation (respiratory sinus arrhythmia) with
      high heart rate variability. Sham-biofeedback takes place under identical testing and
      environmental conditions with subjects looking at a computer screen but not having heart rate
      variability recorded and visualized. Moreover, the patients do not follow any breathing
      instructions, which could possibly have any influence on the heart rate variability. The sham
      intervention is applied to rule out any placebo effect.

      Before the first and after the last biofeedback-session, measurements of heart rate
      variability and polygraphical recordings of further autonomic functions (sudomotor function
      and vasomotor function) are undertaken. Severity of the autonomic functions is captured by a
      specific survey (Survey of Autonomic Symptoms). The modified Rankin Scale is used to assess
      functional outcome after acute ischaemic stroke at baseline, with the conclusion of the
      biofeedback-sessions, and in the context of a telephone-interview after a period of 3 months.
      Furthermore, severity of common stroke related symptoms is recorded at baseline and after the
      last training session using the National Institutes of Health Stroke Scale. All assessments
      as well as all biofeedback training sessions take place at the Stroke Unit of the Department
      of Neurology, University Hospital Carl Gustave Carus Dresden, Germany.
    

Intervention name(s): Biofeedback; Sham-Biofeedback
Intervention type(s): Other; Other
Intervention description(s): 9 x 10 minutes biofeedback sessions over period of three days; 9 x 10 minutes sham-biofeedback sessions over period of three days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Ischaemic Stroke; Heart Rate Variability; Autonomic Nervous System; cardiac autonomic dysfunction; sudomotor function; vasomotor function