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Confirmation of safety for patients with traumatic brain injury by transcranial direct current stimulation (TDCSTBI)

tDCS study for TBI (TDCSTBI)

6

Between February 2021 and December 2022, 6 patients (3 male and 3 female) were enrolled in the prospective study. Five of the patients were in a MCS and 1 was classified as having a SD following a severe brain injury. The average age of injury was 43.7 years. The mean time from injury to tDCS was 778.3 days. All patients were evaluated during hospitalization.

In cases 1 to 6, anodal stimulation was performed on the left dorsolateral frontal region at 2 mA for 20 minutes for 5 consecutive days, and no particular adverse effects were observed. In the variable stimulation period, in cases 1 to 5, anodal stimulation was applied to the right frontal region at 2 mA for 20 minutes once a week in the first course, the left frontal region at 2.5 mA for 20 minutes once a week in the second course, the left frontal region at 2 mA for 20 minutes once a week in the third course, and the left frontal region at 2.5 mA for 20 minutes once a week in the fourth course. In case 6, stimulation was applied over the left frontal region at 2 mA for 20 minutes for 5 consecutive days in the first and second courses, the left frontal region at 3 mA for 20 minutes for 5 consecutive days in the third course, and the left frontal region at 4 mA for 20 minutes for 5 consecutive days in the fourth course.

tDCS stimulation was well tolerated for all 6 subjects in terms of the safety endpoint during the constant stimulus period, with no significant adverse effects including scalp burn and clinical seizure. Although one subject (case 4) underwent 3 days of antibiotics for aspiration pneumonia between courses 3 and 4 of the variable stimulus period, no modification of the treatment regimen was required. Furthermore, no new central nervous system-acting drugs were used during the treatment period in all cases. The incidence of serious adverse events was zero. No significant changes were observed in blood characteristics or head CT scan data between the screening phase, safety check phase, and after the end of the variable stimulation phase.

The CRS-R scores showed an improvement of more than 1 point in 4 out of the 6 cases (66.7%). Three of the patients showed continuous neurological improvement during the observation period (Figure 2). In case 4, a transient improvement in neurological symptoms was observed after the second variable stimulus period. GCS scores improved by more than 1 point in 2 cases (33.3%) (Figure 3). One of these improvements was persistent and one was transient. Specifically, the level of consciousness improved from MCS without language to MCS with language in 2 patients (33.3%), 1 who had a permanent improvement and 1 who had a transient improvement.

A phase I trial investigated the safety of transcranial direct current stimulation (tDCS) in patients with severe traumatic brain injury. They applied constant left frontal anodal stimulation at 2 mA for 20 minutes for 5 consecutive days, with additional variable stimuli to explore different parameters. The trial, following a traditional 3 + 3 study design, found no significant adverse events during both constant and variable stimulation periods. Patients showed improvement in neurological symptoms, with 4

Mar. 31, 2024

Feb. 23, 2024

https://doi.org/10.1016/j.dscb.2024.100123

No

There is no plan to share the data.

https://jrct.niph.go.jp/latest-detail/jRCTs032200263

Higuchi Yoshinori

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba city

yhiguchi@faculty.chiba-u.jp

Higuchi Yoshinori

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba city

+81-43-226-2158

yhiguchi@faculty.chiba-u.jp

Complete

Dec. 23, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Severe traumatic brain injury

transcranial direct current stimulation

traumatic brain injury, subdural hematoma, diffuse brain injury

transcranial direct current stimulation

D000070642, D006408, D000070625

D004599

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.

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

+81-43-226-2616

Sept. 30, 2020

none