We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Dr. Ofer Keren, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01454557
First Posted: October 19, 2011
Last Update Posted: November 1, 2011
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Ofer Keren, Sheba Medical Center
  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: None (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)

Further study details as provided by Dr. Ofer Keren, 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). ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

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
First Submitted: October 10, 2011
First Posted: October 19, 2011
Last Update Posted: November 1, 2011
Last Verified: October 2011

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

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