Cognitive Impairment Associated With Schizophrenia (CIAS)
Conditions
Keywords
schizophrenia, cognitive impairments, temporal interference stimulation
Brief summary
This study aims to evaluate the efficacy and safety of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, and MRI data, will be collected at baseline and at the end of the 2-week intervention.
Detailed description
Cognitive impairment associated with schizophrenia (CIAS) remains a therapeutic challenge, as conventional antipsychotics and depth-limited neurostimulation (NIBS) fail to address the subcortical dysregulation that drives cognitive dysfunction. Temporal Interference Stimulation (TIS) overcomes these biophysical limitations by using intersecting high-frequency electric fields to non-invasively target deep structures such as the hippocampus with great spatial accuracy. Due to its potential to enhance the synchronization between the hippocampus and the prefrontal cortex, TIS offers a new prospect for treating CIAS. This single-arm, open-label trial will evaluate the efficacy of hippocampal-targeted TIS in patients with schizophrenia. Participants will undergo a 10-day intervention (twice daily) and will be assessed using clinical, cognitive (MCCB), and neuroimaging (rs-fMRI) tests at baseline and post-intervention.
Interventions
DEVICEtemporal interference stimulation
TIS will use 2 pairs of electrodes placed according to a 10-10 EEG system and fixed with conductive paste to produce a theta burst stimulation pattern. Electric field modeling will be performed utilizing MRI T1 images to optimize the individualized electrode configuration to generate electric field intensities above 0.6 V/m in the hippocampus of each patient. Each session of stimulation lasts 30 minutes.
Sponsors
Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-50 years old; * meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5) diagnostic criteria; * the diagnosis of schizophrenia is confirmed by the Structured Clinical Interview for DSM-5 (SCID-5); * the disease duration does not exceed 8 years; * 1-2 antipsychotic drugs are taken, and the treatment dose of antipsychotic drugs was stable for at least 1 week before enrollment. Mood stabilizers, antidepressants, and excessive benzodiazepines (lorazepam when 2 doses exceeded 2 mg/d) are not allowed; * The type of antipsychotic drugs remains unchanged during treatment, and the dose is adjusted by no more than 25%; * Impaired functioning in daily activities; * The Global Deficit Score (GDS) for the MATRICS Consensus Cognitive Battery (MCCB) reaches 0.5 or above; * Agree to participate in this study and provide written informed consent
Exclusion criteria
* Presence of other psychiatric comorbidities, intellectual disability, obvious mood symptoms, or substance use disorders (other than caffeine and/or tobacco); * with clear drug-induced extrapyramidal reaction; * A history of seizures, meningitis, or encephalitis; * with contraindications to transcranial electrical stimulation; * History of intracranial tumors or surgery; * history of severe head trauma; * have received other regimens of electrical or magnetic therapy in 1 month before enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes on MCCB scores | Baseline, after 2-week intervention | The MATRICS Consensus Cognitive Battery (MCCB) can be used for cognitive assessment of schizophrenia, bipolar disorder, and other neuropsychiatric diseases. The MCCB covers nine cognitive domains, including attention, information processing speed, verbal learning and memory, visual learning and memory, spatial working memory, reasoning, problem solving, social cognition, executive function, and fine motor skills. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Positive and Negative Symptom Scale (PANSS) scores | Baseline, after 2-week intervention | Range from 30 to 210, higher score indicates more severe positive and negative symptoms. |
| Change in Scale for Assessment of Negative Symptoms (SANS) score | Baseline, after 2-week intervention | The score range is 0-120; the higher the score, the more severe the negative symptoms are. |
| Changes in Psychotic symptom rating scales (PSYRATS) score | Baseline, after 2-week intervention | The Psychotic Symptom Rating Scales (PSYRATS) is a clinician-rated instrument that assesses the multidimensional severity of auditory hallucinations and delusions. It consists of two subscales: an 11-item Hallucinations subscale (total score range 0-44) and a 6-item Delusions subscale (total score range 0-24), with each item rated from 0 to 4. A higher score indicates more severe auditory hallucinations and delusions. |
| Changes in brain function | Baseline, after 2-week intervention | Functional MRI (fMRI) is based on the blood oxygen level dependent (BOLD) contrast that can detect changes in blood oxygenation to analyze the change of brain function after intervention. |
| changes on behavioral performance | Baseline, after 2-week intervention | Behavioral performance will be evaluated by memory task, including Sternberg Item-Recognition Paradigm and mnemonic similarity task. |
| changes of global function. | Baseline, after 2-week intervention | Global function will be measured by the Global Assessment of Functioning (GAF). GAF is a 0-100 numerical scale used by clinicians to subjectively rate a person's overall psychological, social, and occupational functioning. Higher scores (91-100) indicate superior functioning, while lower scores (1-10) indicate severe danger or impairment. |
| adverse event incidences | Day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10. | The adverse event recording form (AERF) includes common adverse reactions induced by TIS. Each item is between 1 (absent) and 4 (severe). A higher score indicates a more severe adverse event. |
Countries
China
Contacts
CONTACTRenrong Wu
CONTACTYue Qin
Outcome results
None listed