Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischemic Stroke (Strokeback01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03865225|
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischaemic Stroke Autonomic Dysfunction||Other: Biofeedback Other: Sham-Biofeedback||Not Applicable|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Sham Comparator: Control group acute ischaemic stroke
Acute ischaemic stroke patients receiving 9 x 10 minutes sham-biofeedback over a period of three days
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
9 x 10 minutes biofeedback sessions over period of three days
- 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
- 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
- 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
- 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)
- 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)
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
|Contact: Timo Siepmann, PD, MD||+49 351 458 35 email@example.com|
|Contact: Paulin Ohlefirstname.lastname@example.org|
|Department of Neurology, University Hospital Carl Gustav Carus Dresden, Germany||Recruiting|
|Dresden, Saxony, Germany, 01307|
|Contact: Timo Siepmann, PD, MD + 49 0351 ext 4583565 email@example.com|
|Principal Investigator:||Timo Siepmann, PD, MD||University Hospital Carl Gustav Carus Dresden, Germany|