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

Primary Purpose

Acquired Brain Injury

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Auditory Stimuli

About this trial

This is an interventional treatment trial for Acquired Brain Injury focused on measuring Acquired Brain Injury, Heart Rate Variability (HRV), Auditory Stimuli, Physical Activity

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

2-4 months from acceptance to rehabilitation medical stable

Exclusion Criteria:

medical unstable a significant hearing deficit premorbid neurological or mental condition

Sites / Locations

Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Acquired Brain Injury

Controls

Arm Description

auditory stimuli for ABI group

Auditory stimuli for control group

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01454557

First Posted

October 10, 2011

Last Updated

October 31, 2011

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01454557

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

November 2011 (undefined)

Primary Completion Date

November 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Brain Injury

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acquired Brain Injury

Arm Type

Experimental

Arm Description

auditory stimuli for ABI group

Arm Title

Controls

Arm Type

Experimental

Arm Description

Auditory stimuli for control group

Intervention Type

Other

Intervention Name(s)

Auditory Stimuli

Intervention Description

Auditory Stimuli during rest and during physical activity

Primary Outcome Measure Information:

Title

Heart Rate Variability

Description

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).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ofer Keren, MD

Phone

972-3-5305183

ofer.keren@sheba.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Aba Ratner, MD

Phone

972-3-5305183

Aba.Ratner@sheba.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ofer Keren, MD

Organizational Affiliation

Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Medical Center

City

Ramat Gan

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aba Ratner, MD

Phone

972-3-5305183

Aba.ratner@sheba.health.gov.il

First Name & Middle Initial & Last Name & Degree

Ofer Keren, MD

Phone

972-3-5305183

ofer.keren@sheba.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

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

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