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

Acquired Brain Injury Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01454557
• Other study ID #: SHEBA-11-8846-OK-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 10, 2011
• Last updated: October 31, 2011
• Start date: November 2011

Study information

• Verified date: October 2011
• Source: Sheba Medical Center
• Contact: Ofer Keren, MD
• Phone: 972-3-5305183
• Email: ofer.keren[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries

Intervention

Other:
• Auditory Stimuli
Auditory Stimuli during rest and during physical activity

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability	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).	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).	No