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A randomized controlled trial to assess the efficacy of continuous theta burst stimulation on cognitive function in post-stroke cognitive impairment

A randomized controlled trial to assess the efficacy of continuous theta burst stimulation on cognitive function in post-stroke cognitive impairment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017997
Enrollment
Unknown
Registered
2018-08-25
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-08-27

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

Conditions

post-stroke cognitive impairment

Interventions

Group 1:cTBS
Group 2:sham-cTBS

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. First stroke confirmed by computed tomography (CT) scan or magnetic resonance imaging (MRI), which occurred less than 12 months; 2. Evidence of stroke related cognitive impairment, documented by neuropsychological evaluation; 3. Aged 40-80 years; 4. Education: primary school (grade 6) or above; 5. Mini-Mental State Examination (MMSE) score of =15; Montreal Cognitive Assessment (MoCA) score less than 26; 6. The Hamilton depression rating scale (HAMD) score of <17; 7. Not on drugs for cognitive improvement; 8. Have a stable and reliable caregiver; 9. Written consent form signed by the patient.

Exclusion criteria

Exclusion criteria: 1. Bilateral or subtentorial lesions; 2. The history of nervous system diseases, including stroke, brain tumor, brain trauma, etc.; 3. Other causes of cognitive decline: AD, PD, FTD, DLB, VitB12 deficiency, hypothyroidism, etc.; 4. Severe alcoholism and drug abuse; 5. Taking medications that may negatively affect cognitive function, such as anticholinergics, antipsychotics and anticonvulsants; 6. Contraindication to MRI scanning; 7. Contraindication to TMS treatment; 8. Psychiatric patients, including schizophrenia, bipolar disorder, major depression or delirium; 9. Vision or hearing problems that lead to poor performance of cognitive tests; 10. Diagnosis of language deficits or aphasia.

Design outcomes

Primary

MeasureTime frame
the Alzheimer’s Disease Assessment Scale, cognitive subscale, ADAS-cog;

Secondary

MeasureTime frame
Montreal Cognitive Assessment, MoCA;Mini-Mental State Examination, MMSE;Digit Span Test;Stroop Test;Trail Making Test;Category Fluency Test;Clock Drawing Test;Modified Barthel Index;Quality of Life;

Countries

China

Contacts

Public ContactGuangqing Xu

Beijing Tiantan Hospital, Capital Medical University

guangchingx@163.com+86 18988991969

Outcome results

None listed

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