An exploratory study to examine the usefulness of the AMPA receptor / GABA receptor expression density ratio in the brain measured from PET images in the prognosis evaluation of stroke hemiplegic patients.

JRCT ID: jRCTs031220365

Registered date:06/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: stroke
• Date of first enrollment: 06/10/2022
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Single intravenous administration of [11C]K-2 and [11C] flumazenil, which radiation dose should bearoud 370MBq ( 333MBq - 407MBq).

Outcome(s)

Primary Outcome

E-I ratio :
Ratio of SUVRAMPAr and SUVRGABAr measured in each brain region

Secondary Outcome

1. E-I ratio :
Ratio of SUVRAMPAr and SUVRGABAr measured in each brain voxel
2. Basic statistics and changes of FMA (before/after PET scannning)
3. Basic statistics and changes of FIM (before/after PET scannning)
4. Basic statistics and changes of SIAS (before/after PET scannning)
5. Basic statistics and changes of WAB (before/after PET scannning)
6. Basic statistic and change amount of upper limb reach range and finger release grasp range measured by each depth sensor before and after PET

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Stroke Patients
1. 40 years older and 75 years younger at the registration
2. Diagnosed as initial symptomatic stroke within 60 days after onset
3. Those who have hemiplegia as a sequela of cerebral infarction or cerebral hemorrhage
4. Those who can start comprehensive rehabilitation for hemiplegia 30 to 90 days after the onset
5. Persons who have obtained documentary consent regarding participation in this research by their own free will.
However, if the consent explanation document cannot be read or written by the subject due to aphasia or paralysis, the witness will witness the entireprocess of informed consent, and the subject will voluntarily study this study at the time of obtainingconsent. Written in writing that you have decided to participate in. Witnesses are adults who are not unduly affected by those involved in this study and who can take a third-party position. If it is determined that aphasia is incapable of giving informed consent, written consent with the signature of the substitute person requested by the person himself / herself is also possible. A surrogate is an adult who is equivalent to a spouse, parent, sibling, child, family member living together, or a close relative, and who can represent the will and interests of the person.
Healthy volunteers
1. 40 years older and 75 years younger at the registration
2. Persons who have obtained documentary consent regarding participation in this research by their own free will.

Exclude criteria

Stroke Patients
(1) Those who have moderate or higher cognitive dysfunction [Raven color matrix test (RCPM) 18 points or less or Mini-mental state test (MMSE) 20 points or less]
(2) Persons with epileptic seizures after cerebral infarction or cerebral hemorrhage
(3) Those who require oral administration of perampanel during this study period
(4) Those who require oral administration of clonazepam or clobazam during this study period
(5) Those who cannot perform 3T-head MRI examination
(6) Those who are undergoing dialysis
(7) Persons with hemiplegia, aphasia, or higherbrain dysfunction due to causes other than cerebral infarction or cerebral hemorrhage
(8) Females suspected of becoming pregnant
(9) In addition, those who are judged to be inappropriate for participation in this study at the discretion of the investigator, etc., such as the inability to implement appropriate contraceptive methods during the study period.
Healthy volunteers
(1) Persons with clinically problematic complications or medical history
(2) Persons with an MMSE of 26 points or less
(3) Persons with a BMI of less than 18.5
(4) Females suspected of becoming pregnant
(5) In addition, those who are judged to be inappropriate for participation in this study at the discretion of the investigator, etc., such as the inability to implement appropriate contraceptive methods during the study period.

Related Information

• Primary Sponsor: Abe Hiroki
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology