Acute Ischaemic StrokeStrokeback01NCT03865225
Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischemic Stroke
A study testing Biofeedback in people with Acute Ischaemic Stroke and Autonomic Dysfunction, run by Technische Universität Dresden at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Ischaemic Stroke, Autonomic Dysfunction
- What is being tested?
- Biofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 25 Nov 2018to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, University Hospital Carl Gustav Carus Dresden, Germany
Dresden, Saxony, 01307
About this study
Official title: Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischaemic Stroke: Protocol for Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Acute Ischaemic Stroke, Autonomic Dysfunction
- Being tested
- Biofeedback, Sham-Biofeedback
- Keywords
- Ischaemic Stroke, Heart Rate Variability, Autonomic Nervous System, cardiac autonomic dysfunction, sudomotor function, vasomotor function
- Medical subject headings
- Primary Dysautonomias, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackOther
9 x 10 minutes biofeedback sessions over period of three days
Sham-BiofeedbackOther
9 x 10 minutes sham-biofeedback sessions over period of three days
| Study group | Role | What they receive |
|---|---|---|
| Control group acute ischaemic stroke | Sham comparator | Acute ischaemic stroke patients receiving 9 x 10 minutes sham-biofeedback over a period of three days Receives: Other: Sham-Biofeedback |
| Treatment group acute ischaemic stroke | Active comparator | Acute ischaemic stroke patients receiving 9 x 10 minutes biofeedback sessions over period of three days Receives: Other: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability in acute ischaemic stroke patients
Measurement of heart rate variability in acute ischaemic stroke patients
Measured: Change from Baseline Heart rate variability at 3 days
Severity of autonomic symptoms
Assessment of autonomic symptoms with Survey of Autonomic Symptoms
Measured: Change from Baseline Severity of autonomic symptoms at 3 days and at 3 months
Measurement of sudomotor and vasomotor function
Assessment of sudomotor and vasomotor function in patients with acute ischaemic stroke prior and after intervention
Measured: Change from Baseline Measurement of sudomotor and vasomotor function at 3 days
Secondary outcomes (2)
Severity of neurological stroke symptoms
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)
Measured: Change from Baseline Severity of neurological stroke symptoms at 3 days
Degree of disability in patients with acute ischemic stroke
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)
Measured: Change from Baseline Functional Outcome at 3 days and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start25 Nov 2018
- Primary completion1 Aug 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Ischaemic StrokeStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, University Hospital Carl Gustav Carus
- Responsible party
- Principal investigator, Timo Siepmann, MD, University Hospital Carl Gustav Carus
- Investigators
- Timo Siepmann, PD, MD, Principal investigator, University Hospital Carl Gustav Carus Dresden, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865225
- Sponsor's protocol ID
- EK389102018
- Acronym
- Strokeback01
- Status last verified
- Jan 2021
- First submitted
- 3 Mar 2019
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
PubMed 28122885Siepmann T, Ohle P, Sedghi A, Simon E, Arndt M, Pallesen LP, Ritschel G, Barlinn J, Reichmann H, Puetz V, Barlinn K. Randomized Sham-Controlled Pilot Study of Neurocardiac Function in Patients With Acute Ischaemic Stroke Undergoing Heart Rate Variability Biofeedback. Front Neurol. 2021 May 26;12:669843. doi: 10.3389/fneur.2021.669843. eCollection 2021.
PubMed 34122314
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heart Rate Variability Biofeedback in Patients With Acute Ischaemic Stroke: Protocol for Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03865225
- Acronym / sponsor ID
- Strokeback01 / EK389102018
- Conditions
- Acute Ischaemic Stroke, Autonomic Dysfunction
- Keywords
- Ischaemic Stroke, Heart Rate Variability, Autonomic Nervous System, cardiac autonomic dysfunction, sudomotor function, vasomotor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, University Hospital Carl Gustav Carus
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group acute ischaemic stroke | Sham comparator | Other: Sham-BiofeedbackAcute ischaemic stroke patients receiving 9 x 10 minutes sham-biofeedback over a period of three days |
| Treatment group acute ischaemic stroke | Active comparator | Other: BiofeedbackAcute ischaemic stroke patients receiving 9 x 10 minutes biofeedback sessions over period of three days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofeedback9 x 10 minutes biofeedback sessions over period of three days | Other | Treatment group acute ischaemic stroke |
| Sham-Biofeedback9 x 10 minutes sham-biofeedback sessions over period of three days | Other | Control group acute ischaemic stroke |
Primary outcome
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
2 secondary outcomes
Severity of neurological stroke symptoms
Time frame: Change from Baseline Severity of neurological stroke symptoms at 3 days
Degree of disability in patients with acute ischemic stroke
Time frame: Change from Baseline Functional Outcome at 3 days and at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Background: PubMed 28122885Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.
- Derived from this study: PubMed 34122314Siepmann T, Ohle P, Sedghi A, Simon E, Arndt M, Pallesen LP, Ritschel G, Barlinn J, Reichmann H, Puetz V, Barlinn K. Randomized Sham-Controlled Pilot Study of Neurocardiac Function in Patients With Acute Ischaemic Stroke Undergoing Heart Rate Variability Biofeedback. Front Neurol. 2021 May 26;12:669843. doi: 10.3389/fneur.2021.669843. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo Siepmann, PD, MD principal investigator
University Hospital Carl Gustav Carus Dresden, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Acute Ischaemic Stroke and Autonomic Dysfunction, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability in acute ischaemic stroke patients (time frame: Change from Baseline Heart rate variability at 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865225, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.