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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032200263

Registered date:23/12/2020

tDCS study for TBI

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSevere traumatic brain injury
Date of first enrollment23/12/2020
Target sample size6
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)transcranial direct current stimulation

Outcome(s)

Primary OutcomeProportion of the following severe adverse events associated with the study device that occurred within the period of constant stimulation treatment will be evaluated. (number of patients occurring/number of patients) 1) Seizures. No previous seizure: new seizure History of seizures: Repeated seizures that occur despite medical treatment. 2) Skin burns Moderate to extensive necrotic tissue removal or plastic surgery is required.
Secondary OutcomeNeurological score (GCS, CRS-R) Changes in neurological scores at each time point and the percentage of cases showing an improvement of at least 1 point from baseline Incidence of adverse events/serious adverse events during the steady-stimulus and variable-stimulus treatment periods and severity

Key inclusion & exclusion criteria

Age minimum>= 16age old
Age maximum<= 80age old
GenderBoth
Include criteria1) Patients with a diagnosis of severe brain injury of 8 or less on the Glasgow Coma Scale (GCS) and requiring hospitalization follwoing 1-2 months after the injury. 2) Patients whose general condition is stable and who can be safely examined and treated. 3) Patients between the ages of 16 and 80 years old at the time of obtaining consent. 4) Patients who provide written informed consent based on free will after receiving sufficient explanation for the study. If the patients lack the capacity to consent to participate in the study, the written informed consent will be obtained freely and voluntarily from the delegate.
Exclude criteria1) Patients who are unable to remain at rest 2) Patients for whom electrodes cannot be placed. 3) Patients with internal metal or electrical devices such as pacemakers or spinal cord stimulators implanted in their bodies. 4) Patients who had a seizure within 30 days prior to use of the device. 5) Pregnant patients. 6) Patients whose examination or treatment is deemed inappropriate by the principal investigator or physician.

Related Information

Contact

Public contact
Name Yoshinori Higuchi
Address 1-8-1 Inohana, Chuo-ku, Chiba city Chiba Japan 260-8670
Telephone +81-43-226-2158
E-mail yhiguchi@faculty.chiba-u.jp
Affiliation Chiba University Hospital
Scientific contact
Name Yoshinori Higuchi
Address 1-8-1 Inohana, Chuo-ku, Chiba city Chiba Japan 260-8670
Telephone +81-43-226-2158
E-mail yhiguchi@faculty.chiba-u.jp
Affiliation Chiba University Hospital