An interventional study of Real Stimulation and Placebo Stimulation in Neurologic Disorder and Brain Injuries, sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Not applicable, Interventional, and Treatment
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)
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 100 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →IRCCS Centro Neurolesi Bonino Pulejo is the lead sponsor of 67 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients in coma patients with metallic brain implants, craniotomy or pacemaker
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 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). Rest Period 2 months.
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 5 seconds 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). Time D: Behavioral assessment using the coma Recovery Scale-R (CRS-R).
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 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.
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).
Coma Recovery Scale-R (CRS-R).
Behavioral assessment using the Coma Recovery Scale-R (CRS-R) for for the assessment of changes in the state of consciousness
Time frame: 4 weeks
Plan to share: No
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IRCCS Centro Neurolesi Bonino Pulejo