The Effect of Auditory Stimuli on Heart Rate Variability (HRV) Among Patients With Acquired Brain Injury (ABI)
This study is not yet open for participant recruitment.
Verified October 2011 by Sheba Medical Center
Sponsor:
Sheba Medical Center
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
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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
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 Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013