Exploratory study to compare AMPA receptors changes during rehabilitation with or without T-817MA

JRCT ID: jRCTs031220728

Registered date:24/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hemiparesis in upper limb after stroke
• Date of first enrollment: 21/04/2023
• Target sample size: 2
• Study type: Interventional

Intervention(s)

[11C]K-2 370MBq 333 - 403 MBq
intravenous injection, twice per participant

Outcome(s)

• Primary Outcome: AMPA receptor change (delta SUVRWM) per brain voxel measured from two [11C]K-2 PETs

Secondary Outcome

(1) Whole-brain SUV-corrected AMPA receptor change (delta SUVRWB)
(2) BPND, SURWWM, and SUVRWB in the frontal lobe, temporal lobe, occipital lobe, parietal lobe, cingulate gyrus, putamen, hippocampus, amygdala, cerebellum, and white matter in the first AMPA-PET
(3) BPND, SURWWM, and SUVRWB of the frontal lobe, temporal lobe, occipital lobe, parietal lobe, cingulate gyrus, putamen, hippocampus, amygdala, cerebellum, and white matter in the second AMPA-PET

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

(1) Males and females aged 20 to 85 at the time of informed consent
(2) Japanese living in Japan
(3) Patients diagnosed with first-onset stroke (excluding subarachnoid hemorrhage) by MRI or CT (Patients with a history of transient ischemic attack and asymptomatic cerebral infarction are eligible for inclusion)
(4)Patients who can undergo the first AMPA-PET imaging within 22 to 56 days after stroke onset as day 1.
(5) Patients with unilateral upper limb paralysis and a total FMA (upper limb motor function) score of 47 or less on the paralyzed side
(6) Patients who can be hospitalized and undergo rehabilitation after obtaining consent until the second AMPA-PET imaging
(7) Patients who can obtain written informed consent to participate in this study from themselves. It is possible to have a fair witness as a third party who agrees to participate in.

Exclude criteria

(1) Patients who cannot answer questions 1) or 2) below or respond to instructions 3) or 4)
1) Month name of the month, 2) Age, 3) Eyes open and closed, 4) Hands-off handshake on healthy side
(2) Severe higher brain dysfunction, severe sensory disturbance, depression, cognitive dysfunction such as schizophrenia, and psychiatric disorders patient
(3) Patients with pain in the upper extremities that disturbs sleep
(4) Patients unable to jointly move the upper extremities or collectively flex the fingers
(5) Patients with a baseline FMA increase of 1 point or less or 9 points or more from the screening FMA value
(6) Hepatic dysfunction (either AST, ALT, or ALP >= 2.5 times the upper limit of institutional reference) or renal dysfunction (serum Cr is 2.0 mg/dl or higher)
(7) Complications that make rehabilitation difficult for the upper extremities (severe heart disease, uncontrolled hypertension, pulmonary embolism, severe orthopedic disease)
(8) Patients with a history or complication of epilepsy
(9) Patients taking perampanel or topiramate (drugs with AMPA receptor antagonism)
(10) Patients who developed convulsions after stroke
(11) Patients who are pregnant or may be pregnant
(12) Breast-feeding patients
(13) Patients who cannot actively participate in rehabilitation
(14) Patients who are contraindicated for MRI imaging (patients with non-MRI compatible cardiac pacemakers, dental implants, patients with non-removable metal inclusions such as tattoos, patients with severe claustrophobia) )
(15) Patients participating in other clinical trials/clinical studies (excluding observational studies) during the study participation period
(16) Patients who have participated in a clinical trial of T-817MA in the past
(17) Patients with alcohol hypersensitivity
(18) Patients who are judged to be inappropriate as research subjects by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Abe Hiroki
• Source(s) of Monetary Support: Takeda Science Foundation Japan Society For The Promotion of Science