The Effect of Auditory Stimuli on Heart Rate Variability (HRV) Among Patients With Acquired Brain Injury (ABI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Ofer Keren, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01454557
First received: October 10, 2011
Last updated: October 31, 2011
Last verified: October 2011
  Purpose

Heart Rate Variability (HRV) reflects the responsiveness of the autonomic system to an external stimuli. The aim of this system is to maintain homeostasis.The variability implies on the interaction between the sympathetic and the parasympathetic systems to maintain the ongoing changes of the autonomic system. Following Acquired Brain Injury (ABI), there can be a damage to the Central Nervous System (CNS) function. The damages described in the literature are cognitive, motor and behavioural function, while there is less relation to the autonomic system. The autonomic system can influence the ability of patient with ABI to participate in the rehabilitation program. The aim of this work is to investigate the activity of the autonomic system activity as manifested by HRV among patients with ABI in different conditions: resting, during activity and while listening to different auditory stimuli.


Condition Intervention
Acquired Brain Injury
Other: Auditory Stimuli

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Auditory Stimuli on Heart Rate Variability (HRV) During Resting and During Physical Activity Among Patients With Acquired Brain Injury (ABI)

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Heart Rate Variability [ Time Frame: first measurement: 2 weeks to 2 months from hospitalization to the department: 24 hours EKG follow up for HRV base line. Last measurement: before the release from rehabilitation (up to 12 months). ] [ Designated as safety issue: No ]
    Heart Rate Variability as measured by HOLTER EKG during the 4 different conditions: first measuerement 2-8 weeks from hospitalization in the TBI rehabilitation department-24 hours detection for HRV baseline. Second measurement: a week after: EKG during the 4 conditions. Third measurement:a month after the first measure, Fourth measurement: 2 months after the first one. Last measurement: Before the release home from rehabilitation (up to one year from the first measurement).


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acquired Brain Injury
auditory stimuli for ABI group
Other: Auditory Stimuli
Auditory Stimuli during rest and during physical activity
Experimental: Controls
Auditory stimuli for control group
Other: Auditory Stimuli
Auditory Stimuli during rest and during physical activity

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 2-4 months from acceptance to rehabilitation medical stable

Exclusion Criteria:

  • medical unstable a significant hearing deficit premorbid neurological or mental condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454557

Contacts
Contact: Ofer Keren, MD 972-3-5305183 ofer.keren@sheba.health.gov.il
Contact: Aba Ratner, MD 972-3-5305183 Aba.Ratner@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel
Contact: Aba Ratner, MD    972-3-5305183    Aba.ratner@sheba.health.gov.il   
Contact: Ofer Keren, MD    972-3-5305183    ofer.keren@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Ofer Keren, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: Dr. Ofer Keren, The head of the TBI rehabilitation department, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01454557     History of Changes
Other Study ID Numbers: SHEBA-11-8846-OK-CTIL
Study First Received: October 10, 2011
Last Updated: October 31, 2011
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Sheba Medical Center:
Acquired Brain Injury
Heart Rate Variability (HRV)
Auditory Stimuli
Physical Activity

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 14, 2014