Safety study of artificial neural connection in stroke
- Conditions
- Brain infarction, hemorrhage
- Registration Number
- JPRN-jRCTs022210049
- Lead Sponsor
- Kikuchi Naohisa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 17
(1) Age: 20-70
(2) Under the agreement with written consent form
(3) Diagnosed as stroke (brain infarction or hemorrhage) by a physician
(4) Leg Brunstrom Statge VI or worse than IV including walking disability
(5) Chronic phase after stroke onset
(1) Fit into following cases
History of harmful sides effects due to magnetic or electrical stimulation, History of seizure or epilepsy including family members, Hisotry of febrile convulsion, Disease or injury of head, brain, spinal cord including brain surgery, Medical device imlantation such as cardiac pacemaker, neurosurgical clips, battery or pumps, non-titanium metal implants in the head or the stimuls target area of trunk, Prospect of pregnancy
(2) Inappropriate patient decided by a physician, such as cardiovascular disorders
(3) Current participation in clinical trials for an approved drug or clinical device
(4) History of botulinum toxin therapy within 4 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety application of artificial neural connection for 3 months
- Secondary Outcome Measures
Name Time Method Safety application of artificial neural connection after 3 months, Objective sensation regarding the strength of transvertebral magnetic stimulation, Artificial neural connection induced walking, Voluntary walking, Motor evoked potential elicited by transcranial magnetic stimulation, Motor evoked potential elicited by transvertebral magnetic stimulation, Overground walking, Treadmill walking, Brunstrom test, Fugl-Meyer assessment, Modified Ashworth Scale, Magnetic resonance imaging