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Cortical Excitability in Patients With Severe Brain Injury

Primary Purpose

Severe Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Severe Traumatic Brain Injury focused on measuring Severe Brain Injury, Excitability, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Hammel Neurorehabilitation and Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Patients with severe brain injury, awake, but have cognitive problems

Patients with severe brain injury and disorders of consciousness ( in minimally conscious or in vegetative state)

Healthy volunteers

Outcomes

Primary Outcome Measures

Short Afferent Inhibition

Secondary Outcome Measures

Short Intracortical Inhibition
Intracortical Facilitation
Motor threshold

Full Information

First Posted
November 10, 2008
Last Updated
November 10, 2008
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00788723
Brief Title
Cortical Excitability in Patients With Severe Brain Injury
Official Title
Cortical Excitability in Patients With Severe Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury
Keywords
Severe Brain Injury, Excitability, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients with severe brain injury, awake, but have cognitive problems
Arm Title
2
Arm Type
Experimental
Arm Description
Patients with severe brain injury and disorders of consciousness ( in minimally conscious or in vegetative state)
Arm Title
3
Arm Type
Experimental
Arm Description
Healthy volunteers
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
Paired-pulse transcanial magnetic stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Short Afferent Inhibition
Time Frame
Within one week after clinical assessment
Secondary Outcome Measure Information:
Title
Short Intracortical Inhibition
Time Frame
Within one week after clinical assessment
Title
Intracortical Facilitation
Time Frame
Within one week after clinical assessment
Title
Motor threshold
Time Frame
Within one week after clinical assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natallia Lapitskaya, MD
Phone
004587623573
Email
neunla@sc.aaa.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Bjorn, secretary
Phone
0045 8762 3562
Email
neuleb@sc.aaa.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natallia Lapitskaya, MD
Organizational Affiliation
Hammel Neurorehabilitation and Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammel Neurorehabilitation and Research Centre
City
Hammel
ZIP/Postal Code
8450
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natallia Lapitskaya, MD
Phone
004587623573
Email
neunla@sc.aaa.dk
First Name & Middle Initial & Last Name & Degree
Lena Bjorn, secretary
Phone
004587623562
Email
neuleb@sc.aaa.dk
First Name & Middle Initial & Last Name & Degree
Natallia Lapitskaya, MD
First Name & Middle Initial & Last Name & Degree
Sofie Moerk, med.stud.

12. IPD Sharing Statement

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Cortical Excitability in Patients With Severe Brain Injury

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