Transcranial Magnetic Stimulation in Patients With Disorders of Consciousness

Study Overview
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Brief Summary
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Transcranial magnetic stimulation involves the use of alternating magnetic fields to stimulate neurons in the brain.To date, several studies have focused on the use of TMS in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of rTMS with cross-over design.

Detailed Description
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Background:Repetitive transcranial magnetic stimulation (rTMS) was supposed as an experimental approach to disorders of consciousness treatment. Its therapeutic effects have been variously documented. Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and the clinical response of patients with disorders of consciousness and explore the neuromodulatory effects of high-frequency rTMS in DOC. Method:In this randomised,sham-controlled study,real or sham 20 Hz rTMS were applied to the left primary motor cortex (M1) of participants with disorders of consciousness for 5 consecutive days . Evaluations were blindly performed at baseline, immediately after the end of the 5-days treatment and 1 week later with the JFK Coma Recovery Scale-Revised (CRS-R) scale and EEG. Hypothesis:Real rTMS can be an effective awakening method.

Official Title
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Effects of Repetitive Transcranial Magnetic Stimulation on the Disorders of Consciousness

Conditions
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Disorder of Consciousness

Intervention / Treatment
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* Other: rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ages 14 to 65 years old; no centrally acting drugs; no neuromuscular function blockers and no sedation within the prior 24 hours; 4.periods of eye opening (indicating preserved sleep-wake cycles); 5.DOC patients, including vegetative state and minimally consciousness state. Exclusion Criteria: History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems; with a contraindication for rTMS

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This study was designed and performed as a randomized, controlled cross-over trial. All patients were randomly received active 20-Hz rTMS and sham stimulation for 5 consecutive days, in separate sessions spaced one week.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real-sham<br>the group first received real rTMS,then sham one. | Other: rTMS<br>* 20HZ Repetitive Transcranial Magnetic Stimulation<br>|
| Experimental: sham-real<br>the group first received sham rTMS,then real one. | Other: rTMS<br>* 20HZ Repetitive Transcranial Magnetic Stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the JFK Coma Recovery Scale-Revised (CRS-R) scale | The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors. | at baseline (T0), immediately after the end of the 5-day treatment (T1), 1 week later (T2).Investigators observed the changes from baseline to the end of stimulation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG data ( electrophysiological parameters) | delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz) and beta (12-30 Hz).an increase of delta and theta activity usually reflects encephalopathy and/or structural lesions, interpreted as poor outcome predictor of DOC .The power of α and β is related to the chance of recovery. | at baseline (T0), immediately after the end of the 5-day treatment (T1), 1 week later (T2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS;DOC