Subarachnoid Hemorrhage Clinical Trial
Official title:
Cortical Excitability in Patients With Severe Brain Injury
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.
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.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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