Severe Traumatic Brain InjuryNCT00788723
Cortical Excitability in Patients With Severe Brain Injury
A study testing Transcranial Magnetic Stimulation in people with Severe Traumatic Brain Injury and Subarachnoid Hemorrhage, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the study is to evaluate the cortical excitability in the severe brain injured patients. We hypothesize that: 1. There is a continuous decrease in intracortical inhibition from healthy subjects to awake patients with severe brain injury, and to patients with impaired consciousness. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2008to May 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- severe brain injury (Glasgow Coma Scale score (GCS) less than 8 on admission to the acute hospital);
- stable vital functions;
- age over 18 years old;
- informed content from patient/relatives/legal guardian.
Who cannot join
- other neurological diseases than brain injury;
- pregnancy;
- TMS contraindications (epilepsy, metallic implantants: pacemaker or medicine pump, ferromagnetic or electronically operated stapedial implants, haemostatic clips, metallic splinters in the orbit).
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hammel Neurorehabilitation and Research Centre
Hammel, 8450
Natallia Lapitskaya, MD, 004587623573, neunla@sc.aaa.dk
Lena Bjorn, secretary, 004587623562, neuleb@sc.aaa.dk
About this study
The aim of the study is to evaluate the cortical excitability in the severe brain injured patients. We hypothesize that:
- There is a continuous decrease in intracortical inhibition from healthy subjects to awake patients with severe brain injury, and to patients with impaired consciousness.
- Decreased intracortical inhibition correlate with the degree of impairment assessed with the clinical scores in patients with severe brain injury.
Read the detailed description
Design: Prospective controlled non-randomized study. Materials and methods: 30 patients with severe brain injury and 15 healthy volunteers will be included in this study.
The study design is illustrated below:
- Clinical assessment (Rancho Los Amigos Scale, Functional Independence Measure, Early Functional Abilities).
- Somatosensory Evoked Potentials.
- Transcranial Magnetic Stimulation: single and paired stimulation protocols.
Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (awake patients vs patients with disorders of consciousness vs control persons) and intra-individually factors as 1) interstimulus intervals for transcranial magnetic stimulation and clinical scores (RLAS vs FIM vs EFA).
Significance level is set to 0.05 for all effect parameters.
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Severe Brain Injury, Excitability, Transcranial Magnetic Stimulation
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Hypoxia-Ischemia, Brain, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called Paired-pulse transcanial magnetic stimulation
Transcranial magnetic stimulation (TMS) using paired-pulse technique at different interstimulus intervals (ISIs) allows the study of the excitatory and inhibitory system of human motor cortex non-invasively. Motor evoked potentials (MEP) will be recorded, and stored on a VikingSelect (Viasys Healthcare, USA). Two magnetic stimulators (Magstim 200, The Magstim Company Ltd, U.K.) connected through a Bistim and a Magstim figure-of-eight coil will be used for TMS.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with severe brain injury, awake, but have cognitive problems Receives: Device: Transcranial Magnetic Stimulation |
| 2 | Experimental | Patients with severe brain injury and disorders of consciousness ( in minimally conscious or in vegetative state) Receives: Device: Transcranial Magnetic Stimulation |
| 3 | Experimental | Healthy volunteers Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Afferent Inhibition
Measured: Within one week after clinical assessment
Secondary outcomes (3)
Short Intracortical Inhibition
Measured: Within one week after clinical assessment
Intracortical Facilitation
Measured: Within one week after clinical assessment
Motor threshold
Measured: Within one week after clinical assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2009 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Natallia Lapitskaya, MD, Principal investigator, Hammel Neurorehabilitation and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788723
- Sponsor's protocol ID
- HNRC-AAU-08-1
- Status last verified
- Nov 2008
- First submitted
- 10 Nov 2008
- Last updated
- 11 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability in Patients With Severe Brain Injury
- ClinicalTrials.gov ID
- NCT00788723
- Acronym / sponsor ID
- HNRC-AAU-08-1
- Keywords
- Severe Brain Injury, Excitability, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 11 Nov 2008 (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.
The aim of the study is to evaluate the cortical excitability in the severe brain injured patients. We hypothesize that:
- There is a continuous decrease in intracortical inhibition from healthy subjects to awake patients with severe brain injury, and to patients with impaired consciousness.
- Decreased intracortical inhibition correlate with the degree of impairment assessed with the clinical scores in patients with severe brain injury.
Detailed description
Design: Prospective controlled non-randomized study. Materials and methods: 30 patients with severe brain injury and 15 healthy volunteers will be included in this study.
The study design is illustrated below:
- Clinical assessment (Rancho Los Amigos Scale, Functional Independence Measure, Early Functional Abilities).
- Somatosensory Evoked Potentials.
- Transcranial Magnetic Stimulation: single and paired stimulation protocols.
Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (awake patients vs patients with disorders of consciousness vs control persons) and intra-individually factors as 1) interstimulus intervals for transcranial magnetic stimulation and clinical scores (RLAS vs FIM vs EFA).
Significance level is set to 0.05 for all effect parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Transcranial Magnetic StimulationPatients with severe brain injury, awake, but have cognitive problems |
| 2 | Experimental | Device: Transcranial Magnetic StimulationPatients with severe brain injury and disorders of consciousness ( in minimally conscious or in vegetative state) |
| 3 | Experimental | Device: Transcranial Magnetic StimulationHealthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- severe brain injury (Glasgow Coma Scale score (GCS) less than 8 on admission to the acute hospital);
- stable vital functions;
- age over 18 years old;
- informed content from patient/relatives/legal guardian.
Key exclusion criteria (3 listed)
- other neurological diseases than brain injury;
- pregnancy;
- TMS contraindications (epilepsy, metallic implantants: pacemaker or medicine pump, ferromagnetic or electronically operated stapedial implants, haemostatic clips, metallic splinters in the orbit).
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: Paired-pulse transcanial magnetic stimulationTranscranial magnetic stimulation (TMS) using paired-pulse technique at different interstimulus intervals (ISIs) allows the study of the excitatory and inhibitory system of human motor cortex non-invasively. Motor evoked potentials (MEP) will be recorded, and stored on a VikingSelect (Viasys Healthcare, USA). Two magnetic stimulators (Magstim 200, The Magstim Company Ltd, U.K.) connected through a Bistim and a Magstim figure-of-eight coil will be used for TMS. | Device | 1, 2, 3 |
Primary outcome
Short Afferent Inhibition
Time frame: Within one week after clinical assessment
3 secondary outcomes
Short Intracortical Inhibition
Time frame: Within one week after clinical assessment
Intracortical Facilitation
Time frame: Within one week after clinical assessment
Motor threshold
Time frame: Within one week after clinical assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2008.
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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.
Natallia Lapitskaya, MD principal investigator
Hammel Neurorehabilitation and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Severe Traumatic Brain Injury and Subarachnoid Hemorrhage, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 3 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 11 Nov 2008. 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 Denmark. 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 Natallia Lapitskaya, MD (004587623573, neunla@sc.aaa.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Afferent Inhibition (time frame: Within one week after clinical assessment). 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 11 Nov 2008.