Clinical trial NCT06236503: Effect of Transcranial Direct Current Stimulation in Altered States of Consciousness
Official title: Effect of Daily Transcranial Direct Current Stimulation on the Cognitive Evolution of Patients in an Altered State of Consciousness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurologic Disorder
Brain Injuries
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Transcranial Direct Current Stimulation (tDCS) is a non-invasive, painless brain stimulation treatment that uses low-intensity direct electrical currents to stimulate specific parts of the brain. Transcranial Direct Current Stimulation (tDCS) can both facilitate anodic stimulation and inhibit cathodic stimulation specific brain areas since many neurological and psychiatric disorders are connected to hypoactivity or hyperactivity in specific areas of the nervous system. This phenomenon is based on two processes: the reorganization of functional neural circuits and their reconstruction. In light of the studies mentioned above, it is presumed that Transcranial Direct Current Stimulation (tDCS) can be a valuable tool to facilitate the process of neuroplasticity in individuals with chronic neurological diseases and in patients with impaired consciousness following severe brain injury. A previous study demonstrated that a single session of transcranial direct current electrical stimulation could temporarily improve signs of consciousness in patients in a minimally conscious state (MCS)

Detailed description: Transcranial Direct Current Stimulation (tDCS) is a non-invasive, painless brain stimulation treatment that uses low-intensity direct electrical currents to stimulate specific parts of the brain. Transcranial Direct Current Stimulation (tDCS) can both facilitate anodic stimulation and inhibit cathodic stimulation specific brain areas since many neurological and psychiatric disorders are connected to hypoactivity or hyperactivity in specific areas of the nervous system. This phenomenon is based on two processes: the reorganization of functional neural circuits and their reconstruction. In light of the studies mentioned above, it is presumed that Transcranial Direct Current Stimulation can be a valuable tool to facilitate the process of neuroplasticity in individuals with chronic neurological diseases and in patients with impaired consciousness following severe brain injury. A previous study demonstrated that a single session of transcranial direct current electrical stimulation could temporarily improve signs of consciousness in patients in a minimally conscious state (MCS).

The application of weak currents can interact with neural processing, modify plasticity and entrain brain networks, and that this in turn can modify behaviour. The technique is now widely employed in basic and translational research, and increasingly is also used privately in sport, the military and recreation. The proposed capacity to augment recovery of brain function, by promoting learning and facilitating plasticity, has motivated a burgeoning number of clinical trials in a wide range of disorders of the nervous system. In this experimental study, cortical brain areas will be stimulated using transcranial direct current stimulation (tDCS) in patients with impaired consciousness following severe brain injury.

The main aim of this study is to determine whether the long-term effects of Transcranial Direct Current Stimulation (tDCS) stimulation can persist over time and whether this technique could be applied in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with a minimally conscious state will be evaluated and stimulated, provided that written informed consent is obtained from a family member.

Exclusion Criteria:

patients in coma patients with metallic brain implants, craniotomy or pacemaker

Primary outcomes:
measure: Coma Recovery Scale-R (CRS-R).
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
state: Italia
Study officials:
References: