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Effect of Transcranial Direct Current Stimulation in Altered States of Consciousness

NCT06236503 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-01

No results posted yet for this study

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)

Conditions

  • Neurologic Disorder
  • Brain Injuries

Interventions

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).

Sponsors & Collaborators

  • IRCCS Centro Neurolesi Bonino Pulejo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2025-12-20
Completion
2025-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06236503 on ClinicalTrials.gov