Acquired Brain InjuryNCT01454557
The Effect of Auditory Stimuli on Heart Rate Variability (HRV) Among Patients With Acquired Brain Injury (ABI)
A study testing Auditory Stimuli in people with Acquired Brain Injury, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Auditory Stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 2-4 months from acceptance to rehabilitation medical stable
Who cannot join
- medical unstable a significant hearing deficit premorbid neurological or mental condition
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Ramat Gan
Aba Ratner, MD, 972-3-5305183, Aba.ratner@sheba.health.gov.il
Ofer Keren, MD, 972-3-5305183, ofer.keren@sheba.health.gov.il
About this study
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)
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
- Being tested
- Auditory Stimuli
- Keywords
- Acquired Brain Injury, Heart Rate Variability (HRV), Auditory Stimuli, Physical Activity
- Medical subject headings
- Brain Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory StimuliOther
Auditory Stimuli during rest and during physical activity
| Study group | Role | What they receive |
|---|---|---|
| Acquired Brain Injury | Experimental | auditory stimuli for ABI group Receives: Other: Auditory Stimuli |
| Controls | Experimental | Auditory stimuli for control group Receives: Other: Auditory Stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ofer Keren, Sheba Medical Center
- Investigators
- Ofer Keren, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454557
- Sponsor's protocol ID
- SHEBA-11-8846-OK-CTIL
- Status last verified
- Oct 2011
- First submitted
- 10 Oct 2011
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01454557
- Acronym / sponsor ID
- SHEBA-11-8846-OK-CTIL
- Conditions
- Acquired Brain Injury
- Keywords
- Acquired Brain Injury, Heart Rate Variability (HRV), Auditory Stimuli, Physical Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (estimated)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acquired Brain Injury | Experimental | Other: Auditory Stimuliauditory stimuli for ABI group |
| Controls | Experimental | Other: Auditory StimuliAuditory stimuli for control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 2-4 months from acceptance to rehabilitation medical stable
Key exclusion criteria (1 listed)
- medical unstable a significant hearing deficit premorbid neurological or mental condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory StimuliAuditory Stimuli during rest and during physical activity | Other | Acquired Brain Injury, Controls |
Primary outcome
Heart Rate Variability
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofer Keren, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Stimuli in people with Acquired Brain Injury, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofer Keren, MD (972-3-5305183, ofer.keren@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2011.