Traumatic Brain InjuryNCT01628003
Study of Reserves After Traumatic Brain Injury
A study testing Brain MRI and MRI in people with Traumatic Brain Injury, run by Sheba Medical Center at 1 site in Israel.
Trial summary
It is hypothesized that the long-term results of rehabilitation and subsequent aging after Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive, emotional) reserves. The purpose of this study are: 1. to determine whether such reserves exist. 2. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Brain MRI and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Jan 2014
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate-Severe Traumatic Brain Injury according to at least 1 the following:
- Duration of loss of consciousness (LOC) - more then 1/2 hour
- Glasgow Coma Scale (GCS) - less then 13
- Post Traumatic Amnesia (PTA) - more then 24 hours.
- At least 1 year after the injury.
Who cannot join
- Mild Traumatic Brain Injury
- the present state of Post Traumatic Amnesia
- dementia
- the age less than 18 years on the moment of injury
- less than 1 year since the injury
- incapacity of the patient to cooperate in the study (incapacity of any source including physical, mental, and language problems)
- premorbid diagnosis of Mental Retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury
It is hypothesized that the long-term results of rehabilitation and subsequent aging after Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive, emotional) reserves.
The purpose of this study are:
- to determine whether such reserves exist.
- to study their convergent and discriminant validity.
- to study their characteristics.
- Conditions
- Traumatic Brain Injury
- Being tested
- Brain MRI, MRI
- Keywords
- Traumatic Brain Injury, long-term outcome, Brain Reserves, Cognitive Reserves, Emotional Reserves, Patients 1 year or more after Moderate or Severe Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIDevice
Brain MRI
MRIDevice
Physical examination Neuropsychological testing Questionnaires
| Study group | Role | What they receive |
|---|---|---|
| healthy persons | Active comparator | Not described Receives: Device: Brain MRI; Device: MRI |
| patients after moderate-severe TBI | Experimental | Not described Receives: Device: Brain MRI; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological battery
Measured: neuropsychological baterry for every participant will be performed during 3-4 meetings. An expected average for complete neuropsychological assessment is about 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startAug 2009
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628003
- Sponsor's protocol ID
- SHEBA-09-7297-AS-CTIL
- Status last verified
- Jun 2012
- First submitted
- 19 Jun 2012
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01628003
- Acronym / sponsor ID
- SHEBA-09-7297-AS-CTIL
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, long-term outcome, Brain Reserves, Cognitive Reserves, Emotional Reserves, Patients 1 year or more after Moderate or Severe Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2009
- Primary completion
- Jan 2014 (estimated)
- First posted
- 26 Jun 2012 (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.
It is hypothesized that the long-term results of rehabilitation and subsequent aging after Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive, emotional) reserves.
The purpose of this study are:
- to determine whether such reserves exist.
- to study their convergent and discriminant validity.
- to study their characteristics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy persons | Active comparator | Device: Brain MRI, Device: MRI |
| patients after moderate-severe TBI | Experimental | Device: Brain MRI, Device: MRI |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate-Severe Traumatic Brain Injury according to at least 1 the following:
- At least 1 year after the injury.
Key exclusion criteria (7 listed)
- Mild Traumatic Brain Injury
- the present state of Post Traumatic Amnesia
- dementia
- the age less than 18 years on the moment of injury
- less than 1 year since the injury
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 |
|---|---|---|
| Brain MRIBrain MRI | Device | healthy persons, patients after moderate-severe TBI |
| MRIPhysical examination Neuropsychological testing Questionnaires | Device | healthy persons, patients after moderate-severe TBI |
Primary outcome
Neuropsychological battery
Time frame: neuropsychological baterry for every participant will be performed during 3-4 meetings. An expected average for complete neuropsychological assessment is about 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain MRI and MRI in people with Traumatic 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 5 inclusion and 7 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 26 Jun 2012. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological battery (time frame: neuropsychological baterry for every participant will be performed during 3-4 meetings. An expected average for complete neuropsychological assessment is about 8 weeks). 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 26 Jun 2012.