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Clinical Trials/JPRN-jRCTs032200263
JPRN-jRCTs032200263
Recruiting
Phase 1

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

Higuchi Yoshinori0 sites6 target enrollmentDecember 23, 2020
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ConditionsSevere traumatic brain injurytraumatic brain injury, subdural hematoma, diffuse brain injuryD000070642, D006408, D000070625

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Severe traumatic brain injury
Sponsor
Higuchi Yoshinori
Enrollment
6
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 23, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Higuchi Yoshinori

Eligibility Criteria

Inclusion 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.

Exclusion 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.

Outcomes

Primary Outcomes

Not specified

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