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

NCT01454557 | Unknown

• 1 other identifier: SHEBA-11-8846-OK-CTIL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury

Keywords

Acquired Brain Injury; Heart Rate Variability (HRV); Auditory Stimuli; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (2)

Acquired Brain Injury

EXPERIMENTAL

auditory stimuli for ABI group

Other: Auditory Stimuli

Controls

EXPERIMENTAL

Auditory stimuli for control group

Other: Auditory Stimuli

Interventions

Auditory Stimuli OTHER

Auditory Stimuli during rest and during physical activity

Acquired Brain Injury; Controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• months from acceptance to rehabilitation medical stable

You may not qualify if:

• medical unstable a significant hearing deficit premorbid neurological or mental condition

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Brain Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Ofer Keren, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ofer Keren, MD

CONTACT

972-3-5305183; ofer.keren@sheba.health.gov.il

Aba Ratner, MD

CONTACT

972-3-5305183; Aba.Ratner@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The head of the TBI rehabilitation department

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 19, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Last Updated: November 1, 2011

Record last verified: 2011-10

Locations

IL (1)