Cortical Excitability in Patients With Severe Brain Injury

November 10, 2008 updated by: University of Aarhus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Natallia Lapitskaya, MD
  • Phone Number: 004587623573
  • Email: neunla@sc.aaa.dk

Study Locations

  • Denmark
      • Hammel, Denmark, 8450
        • Recruiting
        • Hammel Neurorehabilitation and Research Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Natallia Lapitskaya, MD
        • Sub-Investigator:
          • Sofie Moerk, med.stud.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Paired-pulse transcanial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short Afferent Inhibition
Time Frame: Within one week after clinical assessment
Within one week after clinical assessment

Secondary Outcome Measures

Outcome Measure
Time Frame
Short Intracortical Inhibition
Time Frame: Within one week after clinical assessment
Within one week after clinical assessment
Intracortical Facilitation
Time Frame: Within one week after clinical assessment
Within one week after clinical assessment
Motor threshold
Time Frame: Within one week after clinical assessment
Within one week after clinical assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Natallia Lapitskaya, MD, Hammel Neurorehabilitation and Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ANTICIPATED)

March 1, 2009

Study Completion (ANTICIPATED)

May 1, 2009

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (ESTIMATE)

November 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2008

Last Update Submitted That Met QC Criteria

November 10, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNRC-AAU-08-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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