Safety study of artificial neural connection in stroke

JRCT ID: jRCTs022210049

Registered date:19/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Brain infarction, hemorrhage
• Date of first enrollment: 09/12/2022
• Target sample size: 17
• Study type: Interventional
• Intervention(s): Closed-loop, non-invasive, transvertebral magnetic stimulation triggered by an artificial neural connection

Outcome(s)

• Primary Outcome: Safety application of artificial neural connection for 3 months
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Kikuchi Naohisa
• Secondary Sponsor: Nishimura Yukio,Japan Society for the Promotion of Science,Tokyo Metropolitan Government