Actively Recruiting
Effect of Daily Transcranial Direct Current Stimulation on the Cognitive Evolution of Patients in an Altered State of Consciousness
Led by IRCCS Centro Neurolesi Bonino Pulejo · Updated on 2025-05-01
100
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of Transcranial Direct Current Stimulation (tDCS), a painless, non-invasive brain stimulation technique that uses low-intensity electrical currents to target specific brain areas. This method aims to promote brain plasticity and improve function in people with chronic neurological conditions and those with impaired consciousness after severe brain injury. The study focuses on whether long-term tDCS can have lasting benefits for patients in altered states of consciousness, building on prior findings that a single session can temporarily improve signs of consciousness in minimally conscious patients. The study compares two groups: one receiving real tDCS and the other receiving placebo stimulation. Real stimulation involves 20 minutes of frontal brain stimulation daily, five days a week for four weeks, with electrodes placed on specific scalp locations. The placebo group receives brief five-second stimulation under the same schedule. Both groups undergo behavioral assessments using the Coma Recovery Scale-R (CRS-R) before and after the stimulation period. Following the treatment phase, a two-month rest period is included for the real stimulation group. Participants will be assessed regularly using the CRS-R to evaluate changes in consciousness levels over the four weeks of stimulation and after the rest period. The study will collect behavioral data to measure cognitive evolution and monitor safety. Throughout the trial, patients' responses to stimulation and any changes in their state of consciousness will be carefully recorded to determine the persistence of tDCS effects. Overall participation spans several months, including treatment and follow-up phases.
CONDITIONS
Brief Title
Effect of Transcranial Direct Current Stimulation in Altered States of Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with a minimally conscious state
- Age between 18 and 75 years
- Written informed consent obtained from a family member
You will not qualify if you...
- Patients in coma
- Patients with metallic brain implants
- Patients who have had craniotomy
- Patients with a pacemaker
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive daily transcranial direct current stimulation (tDCS) to stimulate specific brain areas. Stimulation is applied once a day, 5 days a week, for 4 weeks, along with behavioral assessments using the Coma Recovery Scale-R.
Daily visits, 5 days a week, for 4 weeks
Duration - 2 months
Participants undergo a rest period to assess the lasting effects of tDCS on cognitive function, with behavioral assessments performed during this time.
At least 1 follow-up visit during rest period
Trial Site Locations
Total: 1 location
1
IRCCS Centro Neurolesi Bonino Pulejo
Messina, Italia, Italy, 98124
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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