Text Size

Cortical Excitability in Patients With Severe Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00788723
First received: November 10, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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. Decreased intracortical inhibition correlate with the degree of impairment assessed with the clinical scores in patients with severe brain injury.

Condition Intervention
Severe Traumatic Brain Injury
Subarachnoid Hemorrhage
Anoxic Brain Injury
 Device: Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cortical Excitability in Patients With Severe Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Short Afferent Inhibition [ Time Frame: Within one week after clinical assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short Intracortical Inhibition [ Time Frame: Within one week after clinical assessment ] [ Designated as safety issue: No ]
  • Intracortical Facilitation [ Time Frame: Within one week after clinical assessment ] [ Designated as safety issue: No ]
  • Motor threshold [ Time Frame: Within one week after clinical assessment ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients with severe brain injury, awake, but have cognitive problems
 Device: Transcranial 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.
Other Name: Paired-pulse transcanial magnetic stimulation
Experimental: 2
Patients with severe brain injury and disorders of consciousness ( in minimally conscious or in vegetative state)
 Device: Transcranial 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.
Other Name: Paired-pulse transcanial magnetic stimulation
Experimental: 3
Healthy volunteers
 Device: Transcranial 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.
Other Name: Paired-pulse transcanial magnetic stimulation

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:

  1. Clinical assessment (Rancho Los Amigos Scale, Functional Independence Measure, Early Functional Abilities).
  2. Somatosensory Evoked Potentials.
  3. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. severe brain injury (Glasgow Coma Scale score (GCS) less than 8 on admission to the acute hospital);
  2. stable vital functions;
  3. age over 18 years old;
  4. informed content from patient/relatives/legal guardian.

Exclusion Criteria:

  1. other neurological diseases than brain injury;
  2. pregnancy;
  3. TMS contraindications (epilepsy, metallic implantants: pacemaker or medicine pump, ferromagnetic or electronically operated stapedial implants, haemostatic clips, metallic splinters in the orbit).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788723

Contacts
Contact: Natallia Lapitskaya, MD 004587623573 neunla@sc.aaa.dk
Contact: Lena Bjorn, secretary 0045 8762 3562 neuleb@sc.aaa.dk

Locations
Denmark
Hammel Neurorehabilitation and Research Centre Recruiting
Hammel, Denmark, 8450
Contact: Natallia Lapitskaya, MD     004587623573     neunla@sc.aaa.dk    
Contact: Lena Bjorn, secretary     004587623562     neuleb@sc.aaa.dk    
Principal Investigator: Natallia Lapitskaya, MD            
Sub-Investigator: Sofie Moerk, med.stud.            
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Natallia Lapitskaya, MD Hammel Neurorehabilitation and Research Centre
  More Information

No publications provided

Responsible Party: Natallia Lapitskaya, MD, Hammel Neurorehabilitation and Research Centre
ClinicalTrials.gov Identifier: NCT00788723     History of Changes
Other Study ID Numbers: HNRC-AAU-08-1
Study First Received: November 10, 2008
Last Updated: November 10, 2008
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by University of Aarhus:
Severe Brain Injury
Excitability
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Hypoxia, Brain
Hemorrhage
Subarachnoid Hemorrhage
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
 Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013