Phase 2 N=62 Randomized Triple-blind Treatment

Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

Vegetative State · Minimally Conscious State · Disorders of Consciousness

Bottom Line

View on ClinicalTrials.gov: NCT01673126 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Change in CRS-R Total Scores — 12.17; 10.60 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Anodal tDCS (Device); sham tDCS (Device)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: University of Liege
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in CRS-R Total Scores	12.17; 10.60	—
SECONDARY Influence of Diagnosis on the Results	—	—
SECONDARY Influence of Etiology on the Results	—	—
SECONDARY Influence of Time Since Insult on the Results	—	—

Summary

Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a double-blind sham-controlled experimental design.

Eligibility Criteria

Inclusion Criteria

post-comatose patients
patients in vegetative/unresponsive or minimally conscious state
patients with stable cardiorespiratory parameters
patients free of sedative drugs and Na+ or Ca++ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)

Exclusion Criteria

premorbit neurology antecedent
patients in coma or <1week after the acute brain insult
patients with a metallic cerebral implant or a pacemaker (in line with the safety criteria for tDCS in humans)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01673126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.