Safety study of artificial neural connection

JRCT ID: jRCTs022200002

Registered date:08/05/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Spinal cord injury: Chronic phase
• Date of first enrollment: 05/10/2020
• Target sample size: 17
• Study type: Interventional
• Intervention(s): Closed-loop, non-invasive, transvertebral magnetic spinal cord stimulation triggered by artificial neural connection

Outcome(s)

• Primary Outcome: Safety of application of artificial neural connection
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 70age old
• Gender: Both

Include 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

Exclude 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

Related Information

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