Clinical trial NCT00788723: Cortical Excitability in Patients With Severe Brain Injury
Official title: Cortical Excitability in Patients With Severe Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Traumatic Brain Injury
Subarachnoid Hemorrhage
Anoxic Brain Injury
Keywords: Severe Brain Injury
Excitability
Transcranial Magnetic Stimulation
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: Short Afferent Inhibition
timeFrame: Within one week after clinical assessment
Secondary outcomes:
measure: Short Intracortical Inhibition
timeFrame: Within one week after clinical assessment
measure: Intracortical Facilitation
timeFrame: Within one week after clinical assessment
measure: Motor threshold
timeFrame: Within one week after clinical assessment
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation and Research Centre
Study officials:
affiliation: Hammel Neurorehabilitation and Research Centre
name: Natallia Lapitskaya, MD
role: PRINCIPAL_INVESTIGATOR
References: