- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01454557
The Effect of Auditory Stimuli on Heart Rate Variability (HRV) Among Patients With Acquired Brain Injury (ABI)
October 31, 2011 updated by: Dr. Ofer Keren, Sheba Medical Center
The Effect of Auditory Stimuli on Heart Rate Variability (HRV) During Resting and During Physical Activity Among Patients With Acquired Brain Injury (ABI)
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aba Ratner, MD
- Phone Number: 972-3-5305183
- Email: Aba.ratner@sheba.health.gov.il
Study Locations
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Ramat Gan, Israel
- Sheba Medical Center
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Contact:
- Aba Ratner, MD
- Phone Number: 972-3-5305183
- Email: Aba.ratner@sheba.health.gov.il
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 2-4 months from acceptance to rehabilitation medical stable
Exclusion Criteria:
- medical unstable a significant hearing deficit premorbid neurological or mental condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acquired Brain Injury
auditory stimuli for ABI group
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Auditory Stimuli during rest and during physical activity
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Experimental: Controls
Auditory stimuli for control group
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Auditory Stimuli during rest and during physical activity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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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).
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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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ofer Keren, MD, Sheba Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Anticipated)
November 1, 2012
Study Registration Dates
First Submitted
October 10, 2011
First Submitted That Met QC Criteria
October 17, 2011
First Posted (Estimate)
October 19, 2011
Study Record Updates
Last Update Posted (Estimate)
November 1, 2011
Last Update Submitted That Met QC Criteria
October 31, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-11-8846-OK-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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