nTMS for Negative Symptom in Schizophrenia
ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 60
SponsorCentral South University
About this trial
This research aims to test the effectiveness of Navigated transcranial magnetic stimulation (nTMS) of left Supramarginal Gyrus for negative symptoms. In this double-blind, randomized controlled trial, patients will be assigned to active iTBS experimental group or sham iTBS group. Treatment will last for 10 days, and data will be collected at baseline, 1 day and 1 month after treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1.Clinical diagnosis of schizophrenia according to ICD-11.
2.Confirmation of the diagnosis of schizophrenia using the SCID-5-RV (DSM-5 Structured Clinical Interview for DSM-5 Disorders - Research Version).
3.Score more than 4 points on either item of negative symptoms (N1-N7).
4.Aged less than 60 years.
Disqualifiers
1.Clinical diagnosis or SCID-5-RV assessment confirming neurodevelopmental disorders, bipolar and related disorders, substance use disorders (excluding alcohol and tobacco).
2.Presence of severe or acute physical illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute cardiovascular diseases, acute respiratory system diseases, acute hematological disorders, etc.
3.Presence of clearly defined genetic diseases, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47,XXY), etc.
4.Contraindication for MRI examination or rTMS, such as metal implantation in the body, epilepsy, cochlear implants, etc.
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent theta burst stimulation(iTBS)
DeviceBy using the TMS Navigation System, the iTBS will be targeted at the left Supramarginal Gyrus.iTBS will be performed using Magstim Rapid² stimulator, parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, intensity of 90% resting motor threshold(RMT), total duration of 10 minutes.
Sham stimulation
DevicePatients in sham group would receive the same intervention procedure as the active ITBS group, but the coil will be replaced with sham coil, which provides the sensation of TBS without enough magnetic energy to reach the cortex.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: experimental group: active iTBSExperimental treatment 1 intervention
Group B: control group: sham iTBSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Positive and Negative Symptom Scale (PANSS) score
The PANSS measures positive symptoms, negative symptoms and general psychopathology. It contains 30 items, each item is scored from 1 to 7, higher score indicates more severe psychopathology in the dimension. Here the investigators use the Chinese version of the PANSS to evaluate the severity of symptoms in schizophrenia in different participant and different treatment phase. The investigators mainly focus on change in the total score of the negative symptoms.
Time frame
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)2
Change in Scale for Assessment of Negative Symptoms(SANS) score
The SANS measures the severity of negative symptoms in schizophrenia. It contains 24 items, each item is scored from 0 to 5, higher score indicates more severe symptom. The SANS evaluates five dimensions of the negative symptoms, which are apathy, poverty of thought, abulia, social withdrawal and disorders of attention.
Time frame
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)Secondary outcomes
1
Change in MATRICS Consensus Cognitive Battery (MCCB) score
The MCCB measures the cognitive function in schizophrenia and other neuropsychiatric diseases. It 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. Raw scores are converted to scale scores, then to normalized T scores. T scores of seven domains and composite score are further calculated. The changes of scores at different follow up timepoint will be used for assessing the improvement of cognitive function (higher score means a better outcome).
Time frame
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)2
The data of head resting-state functional magnetic resonance imaging
All patients undergo head MRI scans in Siemens Trio 3.0T scanner. Resting functional MRI will be acquired based on Blood Oxygenation Level Dependent (BOLD) contrast. It can detect changes in blood oxygenation to analyze the change of brain function after intervention.
Time frame
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)3
Change in Personal and Social Performance Scale (PSP) score
The PSP is a 100-point single-item rating scale that assesses four important domains of patients with mental disorders : (a) socially useful activities, including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behaviors. Higher score indicates better social function.
Time frame
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)4
Change in Global Assessment Function (GAF) score
The GAF is a 100-point single-item rating scale that evaluate level of patients with schizophrenia, combining the level of social function and the severity of psychiatric symptoms to produce a single score. Higher score indicates better social function.
Time frame
Baseline, the day of the end of treatment (day 11±1), 1 month after the treatment (day40±7)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov