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The exploratory clinical trial to evaluate the efficacy of [11C]K-2 in stroke patients under rehabilitation.

The exploratory clinical trial to evaluate the efficacy of [11C]K-2 in stroke patients under rehabilitation. - The evaluation of [11C]K-2 in rehabilitation process.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029952
Enrollment
20
Registered
2018-01-04
Start date
2018-01-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral infarction sequela

Interventions

Rehabilitation for 28 days

Sponsors

Yokohama City University
Lead Sponsor
Yokohama Brain and Spine Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) All patients aged between 20 and 80 years old at the onset of cerebral infarction 2) All patients transferred to the rehabilitation hospital between 7 and 60 days after the onset of cerebral infarction 3) All patients with paralysis in upper and lower limbs at the onset 4) All patients with mRS 0 or 1 before the onset of cerebral infarction 5) All patients who had the initial cerebral infarction (Regardless of asymptomatic cerebral infarction revealed by the history and MRI) 6) All patients with the Infarction at least one in corona radiata, internal capusule, and brainstem and without the concurrence infarction outside the pyramidal tract 7) All patients with necessity to admitted to rehabilitation hospital over 30 days. 8) All patients with the ability to express their participation to this trial by their own will and by their own sign. When without the ability due to their functional loss, their proxies can sign consent form

Exclusion criteria

Exclusion criteria: 1) All patients with the psychiatric disorders which demand the administration of anti depressants such as tricyclic, tetracyclic, SSRI, SNRI and NaSSa 2) All patients with cognitive disorders; the score of Mini-Mental State Examination under 23 3) All patients who had other neurologic and spinal diseases which affect motor and sensory function in upper and lower limb. 4) All patients who participated to other clinical trial (excluded observational study) in 6 months before their consent to this trial. 5) All patients who had contraindication to MRI and/or had the specific lesion other than cerebral infarction 6) All patients with the hemodialysis treatment 7) All patients with liver dysfunction (AST over 150 IU/ml and/or ALT over 150 IU/m) in screening phase 8) All patients with renal dysfunction (eGFR over 60) in screening phase 9) All patients with current or past epilepsy 10) All patients with the administration of anti epileptic drugs 11) All patients planned to under take the constraint-induced movement therapy and rTMS therapy in their admission 12) All patients who were breast-feeding, pregnant or suspected pregnant 13) All patients who desire to be pregnant and can not contraception between the inclusion and the 2nd PET study 14) All patients judged to be unsuitable to this trial by the chief and/or other doctors in the team

Design outcomes

Primary

MeasureTime frame
The difference of AMPA receptor distributions after one month rehabilitation in each brain region in stroke patients.

Countries

Japan

Contacts

Public ContactAkane Sano

Yokohama City University Graduate School of Medicine Department of Physiology

akane@yokohama-cu.ac.jp045-787-2579

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026