Status:
TERMINATED
tDCS in Patients With Disorder of Consciousness Due to Severe Acquired Brain Injury
Lead Sponsor:
Montecatone Rehabilitation Institute S.p.A.
Conditions:
Consciousness Disorders
Brain Injuries
Eligibility:
All Genders
16+ years
Brief Summary
The present observational study is aimed at reporting the short-, mid- and long-term outcomes of patients with Disorder of Consciousness (DOC), in Vegetative State (VS) or Minimally Conscious State (M...
Detailed Description
Patients surviving sABI resulting in a coma state, thanks to improvements in early intervention and intensive care technologies, in some cases begin to regain vigilance and consciousness within few we...
Eligibility Criteria
Inclusion
- patients with Disorder of Consciousness, VS (= LCF 2) or MCS (= LCF 3), due to sABI;
- any etiology, with the exception of extensive haemorrhagic lesions;
- stable clinical conditions.
Exclusion
- presence of implanted devices (e.g. pacemakers, intrathecal infusers);
- presence of metallic brain implants (clips) or intracranial implants;
- presence of extensive craniotomy involving the area of application of tDCS;
- history of epileptic seizure;
- mechanical ventilation in place;
- history of psychotic disorders;
- severe neurodegenerative pathology;
- pharmacotherapy with Na+ or Ca++ channel blockers (e.g. Carbamazepine) or with N-Methyl-D-aspartate (NMDA) receptor antagonists (e.g. Dextromethorphan);
- pregnancy in progress.
Key Trial Info
Start Date :
June 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03367078
Start Date
June 18 2018
End Date
June 30 2020
Last Update
August 14 2020
Active Locations (1)
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1
Montecatone Rehabilitation Institute S.p.A.
Imola, BO, Italy, 40026