tDCS in Patients With Disorder of Consciousness Due to Severe Acquired Brain Injury

NCT03367078 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2020-08-14

No results posted yet for this study

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 (MCS), due to a severe Acquired Brain Injury (sABI), after repeated treatments with anodal Transcranial Direct Current Stimulation (tDCS) on Left Dorsolateral Prefrontal Cortex (L-DLPFC), to stimulate recovery of consciousness. The results obtained will also be compared with those of a historical control cohort, before the introduction of tDCS, matched for demographic and clinical characteristics.

Conditions

  • Consciousness Disorders
  • Brain Injuries
  • Vegetative State
  • Minimally Conscious State
  • Cognitive Impairment

Interventions

DEVICE

Anodal tDCS

Anodal tDCS, on L-DLPFC area, is started 2 weeks after admission to the sABI Operative Unit with: one session per day (in the morning), possibly for 5 consecutive days per week (from Monday to Friday), for 2 consecutive weeks. Each tDCS session lasts 20 minutes. Current intensity is 1 mA during the first week, 2 mA in the second week

OTHER

Usual care

Usual care of DOC patients

Sponsors & Collaborators

  • Montecatone Rehabilitation Institute S.p.A.

    lead OTHER

Principal Investigators

  • Angela Morreale, MD · Montecatone Rehabilitation Institute S.p.A.

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03367078 on ClinicalTrials.gov