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

Not Applicable

• Conditions: Acquired Brain Injury
• Interventions: Other: Auditory Stimuli

• Registration Number: NCT01454557
• Lead Sponsor: Sheba Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-19
• Last Update Submitted: 2011-10-31
• Study Start: 2011-11
• Last Update Posted: 2011-11-01
• Primary Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acquired Brain Injury	Auditory Stimuli	auditory stimuli for ABI group
Controls	Auditory Stimuli	Auditory stimuli for control group

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	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).

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel