AMPA receptors PET imaging in stroke-aphasia patients

JRCT ID: jRCTs031200289

Registered date:08/01/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Stroke, aphasia
• Date of first enrollment: 10/05/2021
• Target sample size: 8
• Study type: Other
• Intervention(s): Single intravenous administration of [11C]K-2, which radiation dose should be aroud 370MBq ( 333MBq - 407MBq).

Outcome(s)

• Primary Outcome: Changes of WAB scores during 8 weeks-speech therapy and delta %SUV of [11C]K-2 in language related areas (LanA) and its homologous areas (HomA). In this study, LanRA reffers to precentralgyrus, supramarginal gyrus, angular gyrus, superior and middle temporal gyrus, posterior inferior temporal gyrus and inferior frontal gyrus in lesional hemisphere, while HomA reffers to those in contra-lesional hemisphere.

Secondary Outcome

1. Changes of WAB scores during 8 weeks-speech therapy and delta SUVRs (ref. : white matter) in LanRA and HomA
2. Changes of WAB scores during 8 weeks-speech therapy and %SUV in LanRA and HomA at 1st PET scan
3. Changes of WAB scores during 8 weeks-speech therapy and %SUV in LanRA and HomA at 2nd PET scan
4. Changes of WAB scores during 8 weeks-speech therapy and SUVR (ref. : white matter) in LanRA and HomA at 1st PET scan
5. Changes of WAB scores during 8 weeks-speech therapy and SUVR (ref. : white matter) in LanRA and HomA at 2nd PET scan
6. Gray matter volume of LanRA and HomA calculated from 1st MRI T1 images based on voxel based morphometry
7. Gray matter volume of LanRA and HomA calculated from 2nd MRI T1 images based on voxel based morphometry
8. Fractional anisotropy value involved in LanRA and HomA calculated from 1st MRI DTI
9. Fractional anisotropy value involved in LanRA and HomA calculated from 2nd MRI DTI
10. Changes of WAB scores during 8 weeks-speech therapy and delta %SUV in each brain region
11. Changes of WAB scores during 8 weeks-speech therapy and delta SUVR (ref. : white matter) in each brain region
12. Changes of WAB scores during 8 weeks-speech therapy and %SUV at 1st PET scan in each brain region
13. Changes of WAB scores during 8 weeks-speech therapy and %SUV at 2nd PET scan in each brain region
14. Changes of WAB scores during 8 weeks-speech therapy and SUVR (ref. : white matter) at 1st PET scan in each brain region
15. Changes of WAB scores during 8 weeks-speech therapy and SUVR (ref. : white matter) at 2nd PET scan in each brain region
Brain regions in 10-15 are defined as below; superior frontal gyrus, middle frontal gyrus, inferior frontal gyrus, straight gyrus, precentral gyrus, anterior orbital gyrus, posterior orbital gyrus, lateral orbital gyrus, medial orbital gyrus, hippocampus, amygdala, parahippocampal gyrus, fusiform gyrus, superior temporal gyrus anterior and posterior part, middle and inferior temporal gyrus, posterior temporal lobe, post central gyrus, superior parietal gyrus, inferiolateral remainder of parietal lobe, lingual gyrus, cuneus, lateral remainder of occipital lobe, insula, subgenus anterior cingulate gyrus, subcallosal are, pre-subgenual anterior cingulate gyrus, caudate nucleus, nucleus accumbens, putamen, thalamus, palladium, substantia nigra, cerebellum, brainstem, and corpus callosum .
16. Changes of WAB scores during 8 weeks-speech therapy and %SUV in each voxel
17. Changes of WAB scores during 8 weeks-speech therapy and SUVR (ref. : white matter) in each voxel

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 86age 12month 48weeks old
• Gender: Both

Include criteria

1. 20 years older and 86 years younger at the registration
2. Diagnosed as initial symptomatic stroke with aphasia
3. A Patient who can express his or her intent to participate in this research with written documents by himself or herself. When a patient is unable to write his or her sign due to their aphasia symptom, a substitute who was asked to write his or her sign by the patient can express intents to participate in this research with written documents in stead of the patient.

Exclude criteria

1. Patients with Raven's coloured porgressive Matrices's score less than 18
2. Patients with Brunstrome stage less than 4 in at least one area among fingers, upper limbs and lower limbs
3. Patients with biochemical examination below ; (a) serum Cr >=2.0 mg/dl, (b) AST >=200 IU/L, (c) ALT >=150 IU/L
4. Patients with post-stroke epilepsy
5. Patients who need an administrarion of perampanel
6. Patients with dialysis
7. Patients who can not undergo head 3T-MRI
8. Patients who desire to undergo non invasive brain stimulation therapy

Related Information

• Primary Sponsor: Abe Hiroki
• Source(s) of Monetary Support: Japan Society for the Promotion of Science,Yokohama Foundation for Advancement of Medical Science
• Secondary ID(s): Nil known