PSCI
Conditions
Interventions
Intervention group 1:Digital therapeutics for post-stroke cognitive impairment (AMD201)
Intervention group 2:Healthe ducation videos
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 18 years old 2. Ischemic or hemorrhagic stroke confirmed by clinical and radiological evidence 3. 3-9 months after first stroke 4. MoCA-B=24(education of > 12 years),MoCA-B=22(education of 7-12 years)or MoCA-B=19(education of 1-6 years) 5. mRS = 3 (Moderate disability) 6. Subjects taking Acetylcholinesterase Inhibitors, NMDA Receptor Antagonists or Sodium Oligomannate capsules should be on stable doses more than 30 days before randomization. 7. Able to complete screening game 8. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Cognitive decline before stroke (IQCODE average =3.19 or total score =51 ) 2. HAMD-17 > 17 3. Have other diseases affecting cognition 4. Received cognitive training within one month prior to enrollment. 5. Unstable conditions or concomitant epilepsy or psychiatric symptoms 6. Impairment of color sensation, vision, hearing, language or extremity movement, not able to complete the study as judged by investigator 7. Use of prohibited medication within 30 days prior to enrollment 8. lliterate 9. Other situations not suitable for study by investigator’s judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-Cog14 (week12); | — |
Secondary
| Measure | Time frame |
|---|---|
| ADAS-Cog14 (week6);VADAS-Cog14 (week6 week12);MoCA-B (week6 week12);TMT-A (week12);HAMD-17 (week12);IADL (week12); | — |
Countries
China
Contacts
Public ContactQidong Chen
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed