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

NCT ID: NCT01454557

Last Updated: 2011-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Brief Summary

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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

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Conditions

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Acquired Brain Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acquired Brain Injury

auditory stimuli for ABI group

Group Type EXPERIMENTAL

Auditory Stimuli

Intervention Type OTHER

Auditory Stimuli during rest and during physical activity

Controls

Auditory stimuli for control group

Group Type EXPERIMENTAL

Auditory Stimuli

Intervention Type OTHER

Auditory Stimuli during rest and during physical activity

Interventions

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Auditory Stimuli

Auditory Stimuli during rest and during physical activity

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 2-4 months from acceptance to rehabilitation medical stable

Exclusion Criteria

* medical unstable a significant hearing deficit premorbid neurological or mental condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Ofer Keren

The head of the TBI rehabilitation department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ofer Keren, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ofer Keren, MD

Role: CONTACT

[email protected]
972-3-5305183

Aba Ratner, MD

Role: CONTACT

[email protected]
972-3-5305183

Facility Contacts

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Aba Ratner, MD

Role: primary

[email protected]
972-3-5305183

Ofer Keren, MD

Role: backup

[email protected]
972-3-5305183

Other Identifiers

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SHEBA-11-8846-OK-CTIL

Identifier Type: -

Identifier Source: org_study_id