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An intervention study on the effect of a new wearable brain rehabilitation instrument on cognitive impairment after stroke

An intervention study on the effect of a new wearable brain rehabilitation instrument on cognitive impairment after stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058991
Enrollment
Unknown
Registered
2022-04-22
Start date
2022-05-31
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

Cerebrovascular disease

Interventions

Experimental group:adjuvant therapy with wearable brain rehabilitation instrument and routine treatment
Control group:routine treatment

Sponsors

Ruian People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with cerebral apoplexy combined with poststroke cognitive impairment (PSCI) who received treatment in our hospital from January 2022 to May 2024; 2. In accordance with the diagnostic criteria of Chinese Medical Association for acute stroke, the vital signs were basically stable and confirmed by head CT or MRI examination; 3. MRS<=2 before onset, no cognitive impairment; 4. Cognitive impairment was determined this time, and the MOCA score was less than 26, which was able to cooperate with the completion of relevant assessment and detection; 5. 40 years <= age < 80 years; 6. Within 2 weeks of the onset of stroke; 7. Patients or their legal representatives sign informed consent before joining the group.

Exclusion criteria

Exclusion criteria: 1. Severe hearing or speech impairment; 2. Mental abnormalities or epilepsy caused by various reasons or unable to correctly assess cognitive function; 3. Patients with brain and heart pacemakers; 4. Patients with special constitution and allergy to multiple drugs; 5. Patients with definite causes of cognitive impairment, such as syphilis, AIDS, thyroid dysfunction, VitB12 deficiency, Notch3 gene mutation, etc.; 6. Patients with severe functional failure and critical condition of important organs and life expectancy of less than 6 months.

Design outcomes

Primary

MeasureTime frame
The score of Mini-mental State Examination;The score of Montreal Cognitive Assessment;Formaldehyde concentration in blood; Formaldehyde concentration in urine;

Secondary

MeasureTime frame
The score of Hamilton Depression Scale (HAMD);The score of Hamilton Anxiety Scale (HAMA);The score of National Institute of Health Stroke Scale (NIHSS);The score of Activities of Daily Living (ADL);

Countries

China

Contacts

Public ContactHuang Xuerong
hxr02@126.com+86 13958860081

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026