tDCS study for TBI

JRCT ID: jRCTs032200263

Registered date:23/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Severe traumatic brain injury
• Date of first enrollment: 23/12/2020
• Target sample size: 6
• Study type: Interventional
• Intervention(s): transcranial direct current stimulation

Outcome(s)

Primary Outcome

Proportion 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 Outcome

Neurological 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
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Higuchi Yoshinori
• Secondary Sponsor: Rehabilitation Center for Traumatic Apallics Chiba, National Agency for Automotive Safety and Victim