NCT06236503

Effect of Transcranial Direct Current Stimulation in Altered States of Consciousness

Effect of Daily Transcranial Direct Current Stimulation on the Cognitive Evolution of Patients in an Altered State of Consciousness

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurologic Disorder
• Brain Injuries

Interventions

Type	Name	Description
BEHAVIORAL	Real Stimulation	Time A: Behavioral assessment using the Coma Recovery Scale-R (CRS-R). · Time B: Transcranial Direct Current Stimulation (tDCS). Frontal stimulation for 20 minutes with the anode placed on the international electrode position and the cathode on the right supraorbital region. Stimulation will be repeated once a day, 5 days a week, for 4 weeks. · Time C. Behavioral assessment using the Coma Recovery Scale-R (CRS-R). Rest Period: 2 months.
BEHAVIORAL	Placebo Stimulation	Time A: Behavioral assessment using the Coma Recovery Scale-R (CRS-R). Time B. Transcranial Direct Current Stimulation (tDCS). Frontal stimulation for 5 seconds with the anode placed on the electrode 10-20 position and the cathode on the right supraorbital region. Stimulation will be repeated once a day, 5 days a week, for 4 weeks. · Time C. Behavioral assessment using the Coma recovery Scale-R (CRS-R). Time D. Behavioral assessment using the Coma Recovery Scale-R (CRS-R).

Timeline

• Start date: 2023-01-10
• Primary completion: 2025-12-20
• Completion: 2025-12-30
• First posted: 2024-02-01
• Last updated: 2025-05-01

Locations

1 site across 1 country: Italy