Cortical Excitability in Patients With Severe Brain Injury

NCT ID: NCT00788723

Last Updated: 2008-11-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-05-31

Brief 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. 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:

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.

Conditions

Severe Traumatic Brain Injury; Subarachnoid Hemorrhage; Anoxic Brain Injury

Keywords

Severe Brain Injury; Excitability; Transcranial Magnetic Stimulation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

2

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

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

3

Healthy volunteers

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Paired-pulse transcanial magnetic stimulation

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Hammel Neurorehabilitation and Research Centre

Principal Investigators

Natallia Lapitskaya, MD

Role: PRINCIPAL_INVESTIGATOR

Hammel Neurorehabilitation and Research Centre

Locations

Hammel Neurorehabilitation and Research Centre

Hammel, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Natallia Lapitskaya, MD

Role: CONTACT

Phone: 004587623573

Email: neunla@sc.aaa.dk

Lena Bjorn, secretary

Role: CONTACT

Phone: 0045 8762 3562

Email: neuleb@sc.aaa.dk

Facility Contacts

Natallia Lapitskaya, MD

Role: primary

Lena Bjorn, secretary

Role: backup

Other Identifiers

HNRC-AAU-08-1

Identifier Type: -

Identifier Source: org_study_id