Cortical Excitability in Patients With Severe Brain Injury

Not Applicable

• Conditions: Severe Traumatic Brain Injury; Subarachnoid Hemorrhage; Anoxic Brain Injury
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT00788723
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study Start: 2008-07
• Status Verified: 2008-11
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-10
• Last Update Submitted: 2008-11-10
• Study First Posted: 2008-11-11
• Last Update Posted: 2008-11-11
• Primary Completion: 2009-03
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Transcranial Magnetic Stimulation	Patients with severe brain injury, awake, but have cognitive problems
2	Transcranial Magnetic Stimulation	Patients with severe brain injury and disorders of consciousness ( in minimally conscious or in vegetative state)
3	Transcranial Magnetic Stimulation	Healthy volunteers

Primary Outcome Measures

Name	Time	Method
Short Afferent Inhibition	Within one week after clinical assessment

Secondary Outcome Measures

Name	Time	Method
Motor threshold	Within one week after clinical assessment
Short Intracortical Inhibition	Within one week after clinical assessment
Intracortical Facilitation	Within one week after clinical assessment

Trial Locations

Locations (1)

Hammel Neurorehabilitation and Research Centre; 🇩🇰 Hammel, Denmark