Closed-loop tDCS in Patients in Minimally Conscious State

Launched by UNIVERSITY OF LIEGE · Jan 17, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new method to help patients in a minimally conscious state (MCS) regain awareness. Researchers are testing a system that uses brain activity measurements to determine the best times to apply a treatment called transcranial direct current stimulation (tDCS). This treatment sends a gentle electrical current to the brain, and the study aims to find out if applying it when patients are more alert (high vigilance) is better than when they are less alert (low vigilance). They will also look at whether different brain activity patterns show up after the treatment and if certain factors like age or the cause of the injury affect the response to the treatment.

To participate in the trial, individuals must be between 16 and 75 years old, have a stable diagnosis of MCS, and be at least 28 days post-injury. They also need to have been on stable medications for at least a week. However, people with certain medical devices like pacemakers or severe health issues that might affect brain activity won't be eligible. Participants can expect to undergo assessments and receive either the active treatment or a placebo (an inactive version) while the researchers monitor their brain activity and overall response. This study is important as it could lead to new ways to support recovery in patients with MCS.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • CNS medication stable for at least a week,
• • Stable diagnosis of MCS (no diagnosis change based on 2 CRS-R performed within 1 week).
• • Adult (16 years old - 75 years old)
• • \> 28 days post injury
• Exclusion Criteria:
• • open craniotomies,
• • VPS under the stimulated area (prefrontal cortex),
• • pacemaker,
• • metallic cerebral implant, according to safety criteria for transcranial electric stimulation,
• • severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).