rTMS and EEG in DOC Patients
Disorder of Consciousness
About this trial
This is an interventional treatment trial for Disorder of Consciousness focused on measuring disorders of consciousness, transcranial magnetic stimulation
Eligibility Criteria
Inclusion Criteria:
- over 18 years old
- > 28 days post-injury
- patients with DOC due to acquired brain lesions classified according to international guidelines as UWS or MCS with repeated behavioural assessments with the CRS-R
- stable vital parameters
- no previous neurological deficits anterior to the brain lesions
- no pregnancy
- no contraindication for rTMS or EEG (e.g., uncontrolled epilepsy, that is, seizure within 4 weeks prior to enrollment, metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device, sensitive skin)
- no sedative drugs and drugs thought to interfere with brain stimulation such as Na or Ca channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)
- no drugs or substances which have strong potential of seizure induction (imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, phencyclidine, ketamine, gamma-hydroxybutyrate, alcohol, and theophylline).
- All etiologies (e.g., trauma, stroke, and anoxia)
Exclusion Criteria:
-
Sites / Locations
- University Hospital of Liège
- Therapiezentrum Burgau
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Sham Comparator
Active Comparator
Active Comparator
Sham Comparator
Active Comparator
Active Comparator
Sham Stimulation Group for Crossover Study (DLPFC + AG)
DLPFC Stimulation Group for Crossover Study
AG Stimulation Group for Crossover Study
Sham Stimulation Group for Parallel Study (DLPFC + AG)
DLPFC Stimulation Group for Parallel Study
AG Stimulation Group for Parallel Study
Sham stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) and on the angular cortex (AG) using a sham coil in the crossover study.
Real stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil in the crossover study.
Real stimulation will be delivered on the left angular cortex (AG) using a real coil in the crossover study.
Sham stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) or on the angular cortex (AG) using a sham coil in the parallel study.
Real stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil in the parallel study.
Real stimulation will be delivered on the left angular cortex (AG) using a real coil in the parallel study.