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Safety study of artificial neural connectio

Phase 1
Conditions
Spinal cord injury: Chronic phase
Registration Number
JPRN-jRCTs022200002
Lead Sponsor
Kikuchi Naohisa
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
17
Inclusion Criteria

(1) Age: 18-70
(2) Under the agreement with written consent form
(3) (Diagnosed as spinal cord injury by a physician
(4) ASIA D or worse than D
(5) Chronic phase after injury
(6) Have upper limb motor function for the use of artificial neural connection

Exclusion Criteria

(1) Fit into following cases
History of harmful sides effects due to magnetic or electrical stimulation, History of seizure or epilepsy, Disease or injury of head, brain, peripheral nerves including brain surgery, Medical device implantation such as cardiac pacemaker, neurosurgical clips, battery or pumps, non-titanium metal implants in the head or the stimulus target area of trunk, Chronic severe migraine, Suspicion of pregnancy, history of seizure or epilepsy in family members
(2) Inappropriate patient decided by a physician
(3) Current participation in clinical trials for an unapproved drug or clinical device

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety of application of artificial neural connection
Secondary Outcome Measures
NameTimeMethod
Artificial neural connection induced walking, Voluntary walking, ASIA scale, Modified Ashworth scale, Motor evoked potential elicited by transcranial magnetic stimulation, Motor evoked potential elicited by transcvertebral magnetic stimulation, Leg movements produced by transvertebral magnetic stimulation, Overground walking, Magnetic resonance imaging
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