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

NCT03865225 | Completed

• 1 other identifier: EK389102018
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischaemic Stroke; Autonomic Dysfunction

Keywords

Ischaemic Stroke; Heart Rate Variability; Autonomic Nervous System; cardiac autonomic dysfunction; sudomotor function; vasomotor function

Outcome Measures

Primary Outcomes (3)

• Heart rate variability in acute ischaemic stroke patients

  Measurement of heart rate variability in acute ischaemic stroke patients

  Change from Baseline Heart rate variability at 3 days

• Severity of autonomic symptoms

  Assessment of autonomic symptoms with Survey of Autonomic Symptoms

  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

  Change from Baseline Measurement of sudomotor and vasomotor function at 3 days

Secondary Outcomes (2)

• Severity of neurological stroke symptoms

  Change from Baseline Severity of neurological stroke symptoms at 3 days

• Degree of disability in patients with acute ischemic stroke

  Change from Baseline Functional Outcome at 3 days and at 3 months

Study Arms (2)

Control group acute ischaemic stroke

SHAM COMPARATOR

Acute ischaemic stroke patients receiving 9 x 10 minutes sham-biofeedback over a period of three days

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

Other: Biofeedback

Interventions

Biofeedback OTHER

9 x 10 minutes biofeedback sessions over period of three days

Treatment group acute ischaemic stroke

Sham-Biofeedback OTHER

9 x 10 minutes sham-biofeedback sessions over period of three days

Control group acute ischaemic stroke

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• University Hospital Carl Gustav Carus: collaborator

Study Sites (1)

Department of Neurology, University Hospital Carl Gustav Carus Dresden, Germany

Dresden, Saxony, 01307, Germany

Location

Related Publications (2)

• 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. Erratum In: Circulation. 2017 Mar 7;135(10):e646. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 BACKGROUND

• Siepmann 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.

  PMID: 34122314 DERIVED

MeSH Terms

Conditions

Primary Dysautonomias; Ischemic Stroke

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Timo Siepmann, PD, MD

  University Hospital Carl Gustav Carus Dresden, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham biofeedback intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Doctor of Medicine, Principal Investigator, Head of neurological emergency room, University Hospital Carl Gustav Carus

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 6, 2019
• Study Start: November 25, 2018
• Primary Completion: August 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

DE (1)