Effect of Transcranial Direct Current Stimulation in Altered States of Consciousness

Brain Injuries Clinical Trial

— tDCS-GCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236503
• Other study ID #: tDCS-GCA
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Nervous System Diseases
• Neurologic Disorder

Intervention

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.
• 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).

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi Bonino Pulejo	Messina	Italia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks