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pBFS-Guided Intermittent Theta Burst Stimulation for Cognitive Impairments Associated with Schizophrenia: A Randomized, Placebo-Controlled, Parallel Trial

pBFS-Guided Intermittent Theta Burst Stimulation for Cognitive Impairments Associated with Schizophrenia: A Randomized, Placebo-Controlled, Parallel Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079624
Enrollment
Unknown
Registered
2024-01-08
Start date
2024-01-09
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Schizophrenia

Interventions

Sponsors

Peking University Sixth Hospital, Peking University Institute of Mental Health
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Participants were recruited who met the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition DSM-5 determined through the Structured Clinical Interview for DSM Disorders SCID Both first-episode and chronic patients were included 2. Aged between 18 and 60 years 3. On a stable medication regimen for at least 4 weeks. 4. Score = 10 on the Calgary Depression Scale for Schizophrenia (CDSS-C). 5. A minimum educational attainment of five years. 6. A score below 26 on the Mini-Mental State Examination (MMSE) and a T-score under 40 on the Chinese MATRICS Consensus Cognitive Battery (MCCB) indicated significant cognitive impairment. 7. Adequate visual, auditory, motor, and comprehension abilities to complete the necessary tests for the study. 8. Understanding of the trial and provision of informed consent.

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria included individuals diagnosed with schizoaffective disorder, mood disorders, intellectual developmental disorder, pervasive developmental disorders, delirium, dementia, memory disorders, or other cognitive impairments according to the DSM-5 criteria. 2. Individuals with pacemakers, cochlear implants, metallic foreign bodies, electronic body devices, MRI contraindications (e.g., claustrophobia), or rTMS treatment contraindications. 3. History of epilepsy, defined as having at least two unprovoked seizures more than 24 hours apart, diagnosed epilepsy syndromes, or seizures in the past 12 months. 4. Recent electroconvulsive therapy (ECT), rTMS, or light therapy within the past three months. 5. Concurrent organic brain diseases, including ischemic stroke, cerebral hemorrhage, brain tumors, or severe traumatic brain injury. 6. Severe cardiac, liver, kidney diseases, diabetes, or other serious physical health conditions. 7. Pregnant or breastfeeding women, and those of childbearing age who plan to or might become pregnant during the study. 8. History of drug or alcohol abuse within the past year. 9. Current risk of self-harm, suicide, or harm to others. 10. Communication difficulties preventing normal interaction, understanding or following instructions, or inability to cooperate with treatment or assessment. 11. Use of cognition-impairing medications like anticholinergics and benzodiazepines; short/intermediate-acting benzodiazepines (e.g., alprazolam, lorazepam) allowed but must be discontinued 48 hours before cognitive testing. 12. Participation in other clinical trials involving medications or physical therapies (e.g., Deep Brain Stimulation, DBS; Electroconvulsive Therapy, ECT; rTMS). 13. Researchers deem the individual unsuitable for study participation.

Design outcomes

Primary

MeasureTime frame
MATRICS Consensus Cognitive Battery;

Secondary

MeasureTime frame
Positive and Negative Syndrome Scale;Clinical Global Impression- Improvement;Treatment Emergent Symptom Scale;Vital Signs;

Countries

China

Contacts

Public ContactYue Weihua

Peking University Sixth Hospital, Peking University Institute of Mental Health

dryue@bjmu.edu.cn+86 188 1089 8027

Outcome results

None listed

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