TIS for Improving Cognitive Impairment in Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorCentral South University
About this trial
This study aims to evaluate the efficacy, safety, and underlying neural mechanisms of TIS targeting the hippocampus in ameliorating cognitive impairment associated with schizophrenia (CIAS). Researchers will compare active TIS to a sham control to see if TIS works to treat CIAS. Participants will receive TIS twice a day for 2 weeks. Their clinical data, including the baseline clinical symptom scale score, cognitive function, E/I imbalance index recorded by EEG, and MRI data, will be collected at baseline, at the end of the 2-week intervention, and 4 weeks after the intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
temporal interference stimulation
DeviceTIS 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.
Sham stimulation
DeviceThe sham stimulation only includes a 15-second ramp-up at the start and ramp-down at the beginning of each stimulus, which could simulate the scalp pulsing sensation caused by the change of current at the beginning and end of the stimulus.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Active TISExperimental treatment 1 intervention
Group B: sham TISSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
changes on the MATRICS Consensus Cognitive Battery (MCCB) scores
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.
Time frame
Baseline, after 2-week intervention, 4 weeks post-treatmentSecondary outcomes
1
Changes in Positive and Negative Symptom Scale (PANSS) scores
Range from 30 to 210, higher score indicates more severe positive and negative symptoms.
Time frame
Baseline, after 2-week intervention, 4 weeks post-treatment2
Change in Scale for Assessment of Negative Symptoms (SANS) score
The score range is 0-120; the higher the score, the more severe the negative symptoms are.
Time frame
Baseline, after 2-week intervention, 4 weeks post-treatment3
Changes in Calgary Depression Scale for Schizophrenia (CDSS) score
Ranges from 0 to 27; a higher score indicates more severe affective symptoms.
Time frame
Baseline, after 2-week intervention, 4 weeks post-treatment4
Changes in brain function
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.
Time frame
Baseline, after 2-week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Central South University
Lead sponsor
Second Xiangya Hospital of Central South University
Sponsor institution
Source ClinicalTrials.gov