Status:
UNKNOWN
rTMS and EEG in DOC Patients
Lead Sponsor:
University of Liege
Collaborating Sponsors:
Therapiezentrum Burgau
Conditions:
Disorder of Consciousness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Severe brain injury could cause chronic disorders of consciousness (DOC). Treating DOC patients to improve recovery remains very challenging. A few randomized controlled studies have been...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04401319
Start Date
July 1 2024
End Date
January 1 2025
Last Update
December 12 2023
Active Locations (2)
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1
University Hospital of Liège
Liège, Belgium, 4000
2
Therapiezentrum Burgau
Burgau, Germany, 89331