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Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischemic Stroke (Strokeback01)

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ClinicalTrials.gov Identifier: NCT03865225
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
University Hospital Carl Gustav Carus
Information provided by (Responsible Party):
Timo Siepmann, MD, University Hospital Carl Gustav Carus

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Ischaemic Stroke Autonomic Dysfunction Other: Biofeedback Other: Sham-Biofeedback Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischaemic Stroke: Protocol for Randomized Controlled Trial
Actual Study Start Date : November 25, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Sham Comparator: Control group acute ischaemic stroke
Acute ischaemic stroke patients receiving 9 x 10 minutes sham-biofeedback over a period of three days
Other: Sham-Biofeedback
9 x 10 minutes sham-biofeedback sessions over period of three days

Active Comparator: Treatment group acute ischaemic stroke
Acute ischaemic stroke patients receiving 9 x 10 minutes biofeedback sessions over period of three days
Other: Biofeedback
9 x 10 minutes biofeedback sessions over period of three days




Primary Outcome Measures :
  1. Heart rate variability in acute ischaemic stroke patients [ Time Frame: Change from Baseline Heart rate variability at 3 days ]
    Measurement of heart rate variability in acute ischaemic stroke patients

  2. Severity of autonomic symptoms [ Time Frame: Change from Baseline Severity of autonomic symptoms at 3 days and at 3 months ]
    Assessment of autonomic symptoms with Survey of Autonomic Symptoms

  3. Measurement of sudomotor and vasomotor function [ Time Frame: Change from Baseline Measurement of sudomotor and vasomotor function at 3 days ]
    Assessment of sudomotor and vasomotor function in patients with acute ischaemic stroke prior and after intervention


Secondary Outcome Measures :
  1. Severity of neurological stroke symptoms [ Time Frame: Change from Baseline Severity of neurological stroke symptoms at 3 days ]
    Assessment of severity of neurological symptoms in patients with acute ischaemic stroke with the National Institutes of Health Stroke Scale (range from 0 to 42)

  2. Degree of disability in patients with acute ischemic stroke [ Time Frame: Change from Baseline Functional Outcome at 3 days and at 3 months ]
    Assessment of functional outcome as the degree of disability in patients with acute ischaemic stroke with the modified Rankin Scale (range from 0 to 6)



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and female subjects aged between 18 and 90
  • written and oral informed consent
  • evidence of an ischaemic lesion on cranial computed tomography scan or magnetic resonance imaging

Exclusion Criteria:

  • intake of any tricyclic antidepressant within the last 14 days
  • atrial fibrillation
  • prior diagnosed autonomic neuropathy
  • malignant cerebral infarct or indication for treatment at intensive care unit
  • aphasia or cognitive deficit with resulted inability to participate in Heart rate variability-biofeedback training
  • respiratory insufficiency
  • blindness, deafness or other physical limitations with resulted inability to participate in heart rate variability-biofeedback training

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865225


Contacts
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Contact: Timo Siepmann, PD, MD +49 351 458 35 65 timo.siepmann@uniklinikum-dresden.de
Contact: Paulin Ohle paulin.ohle@mailbox.tu-dresden.de

Locations
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Germany
Department of Neurology, University Hospital Carl Gustav Carus Dresden, Germany Recruiting
Dresden, Saxony, Germany, 01307
Contact: Timo Siepmann, PD, MD    + 49 0351 ext 4583565    timo.siepmann@uniklinikum-dresden.de   
Sponsors and Collaborators
Technische Universität Dresden
Michael J. Fox Foundation for Parkinson's Research
University Hospital Carl Gustav Carus
Investigators
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Principal Investigator: Timo Siepmann, PD, MD University Hospital Carl Gustav Carus Dresden, Germany

Publications:
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Responsible Party: Timo Siepmann, MD, Assistant Professor, Doctor of Medicine, Principal Investigator, Head of neurological emergency room, University Hospital Carl Gustav Carus, University Hospital Carl Gustav Carus
ClinicalTrials.gov Identifier: NCT03865225     History of Changes
Other Study ID Numbers: EK389102018
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Timo Siepmann, MD, University Hospital Carl Gustav Carus:
Ischaemic Stroke
Heart Rate Variability
Autonomic Nervous System
cardiac autonomic dysfunction
sudomotor function
vasomotor function

Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebral Infarction
Autonomic Nervous System Diseases
Primary Dysautonomias
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia