iTBS on Negative Symptoms and Cognitive Function in Schizophrenia

NCT05137158 | Completed

• 1 other identifier: WU202110TBS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The negative symptoms and cognitive deficits are common in patients with schizophrenia, and do not respond well to antipsychotics. The effective treatments for negative symptoms and cognitive impairment are still to be explored. rTMS is a safe and non-invasive physical treatment, some studies has been indicated that the high frequency rTMS could increase the excitability of cortex, and has potentials to improve negative symptoms and cognitive function in schizophrenia. In this study, we explore the effects of iTBS on negative symptoms and cognitive function based on identifying the brain network connection of schizophrenia symptoms.

Conditions

Schizophrenia

Keywords

Schizophrenia; iTBS; Negative Symptom; Cognitive function

Outcome Measures

Primary Outcomes (5)

• Change in MCCB

  The MATRICS Consensus Cognitive Battery,It 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. The working memory domain does not include verbal working memory because the Chinese language would not make feasible the inclusion of the LNS test.

  From baseline to 11days and the 30th day after the end of stimulation

• Change in Positive and Negative Symptm Scale(PANSS) score

  The scale to assess the severity of symptoms in schizophrenia.It is an evaluation scale of 30 disparate items scored from 1 to 7 for psychopathological symptoms observed in patients presenting psychotic syndromes, especially schizophrenic states.Three scores obtained with this scale are generally calculated for evaluating three dimensions of the syndrome: positive, negative and general psychopathology, as part of a categorial or dimensional perspective.The minimum value is 30 points, and the maximum value is 210 points.The higher the score, the more severe the relevant symptom is.

  From baseline to 11days and the 30th day after the end of stimulation

• Change in Scale for Assessment of Positive Symptoms(SAPS) score

  This scale is used to assess the severity of positive symptoms in schizophrenia. Evaluating four dimensions of the positive symptoms including hallucination, delusion, strange behavior and disorders of the positive thinking form.There are 34 items in the scale, which are divided into four subscales and graded on a six-point scale. The total score of the scale is the sum of 34 individual items, reflecting the severity of positive symptoms. The score range is 0-170, the higher the score, the more severe the symptoms are. The total score of the comprehensive evaluation is the sum of the individual score of the overall evaluation item of the four subscales, which also reflects the severity of positive symptoms, the score range is 0-20. The comprehensive evaluation score of the subscale is the single score of the overall evaluation item of the four subscales, specifically reflecting the severity of the four dimensions of the positive symptoms, the score range is 0-5.

  From baseline to 11days and the 30th day after the end of stimulation

• Change in Scale for Assessment of Negative Symptoms(SANS) score

  This scale is used to assess the severity of negative symptoms in schizophrenia. Evaluating five dimensions of the negative symptoms including apathy, poverty of thought, abulia, social withdrawal and disorders of attention.There are 24 items in the scale, which are divided into five subscales and graded on a six-point scale. The total score of the scale is the sum of 24 individual items, reflecting the severity of positive symptoms. The score range is 0-120, the higher the score, the more severe the negative symptoms are. The total score of the comprehensive evaluation is the sum of the individual score of the overall evaluation item of the five subscales, which also reflects the severity of negative symptoms, the score range is 0-25. The comprehensive evaluation score of the subscale is the single score of the overall evaluation item of the five subscales, specifically reflecting the severity of the five dimensions of the negative symptoms, the score range is 0-5.

  From baseline to 11days and the 30th day after the end of stimulation

• The data of resting-state functional magnetic resonance imaging

  All patients undergo head MRI scans in Philips Achieva 3.0 T scanner and SIEMENS Prisma 3.0 T scanner.

  From baseline to 11days and the 30th day after the end of stimulation

Secondary Outcomes (2)

• Change in Treatment Emergent Symptom Scale(TESS) score

  From baseline to 11days and the 30th day after the end of stimulation

• The blood sample

  From baseline to 11days and the 30th day after the end of stimulation

Study Arms (2)

iTBS stimulation

EXPERIMENTAL

The patients in iTBS stimulation group will receive iTBS stimulation on the target of the left dorsolateral prefrontal cortex for 10 consecutive days and 3 times per day.There will have at least 30 minutes interval between each intervention.

Device: Intermittent theta burst stimulation

Sham stimulation

SHAM COMPARATOR

The participants in sham stimulation will receive sham stimulation, as the coil vertical to the brain surface, for 10 consecutive days and 3 times per day.There will have at least 30 minutes interval between each intervention.

Device: Sham stimulation

Interventions

Intermittent theta burst stimulation DEVICE

Intermittent theta burst stimulation(iTBS) on the left DLPFC, the left DLPFC will be targeted utilizing the localite neuronavigation system. The stimulation intensity is set at 80% of resting motor threshold(RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 600 pulses per session, total duration of 3 minutes and 20 seconds.

iTBS stimulation

Sham stimulation DEVICE

The same procedure will be performed in sham group including the RMT assessment and the neuronavigation system for target localization, but the sham coil will vertical to the brain surface and deliver a very slight magnetic field, which have the same appearance and sound, and provide the same tactile sensations as the active coils.

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with schizophrenia in accordance with DSM-5
• The disease duration ≤8 years
• Received a steady dose of antipsychotic medication for least 4 weeks
• The Global Deficit Score of MCCB ≥0.5 or the PANSS negative subscore ≥20
• No obvious extrapyramidal side effects caused by antipsychotic drugs
• Informed Consent

You may not qualify if:

• Diagnosed with other mental disease in accordance with DSM-5
• Combined with other severe physiological disease
• Used antidepressants, mood stabilizer, or other psychoactive substances before
• Drug or alcohol abuse
• Pregnant or lactating
• Contraindication to rTMS
• Received rTMS or electroconvulsive therapy in the past 1 month

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Second Xiangya Hospital

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Renrong Wu, Prof

  The Second Xiangya Hospital of Central South University Psychiatry Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Sixty participants are randomly and equally divided into intervention group or sham stimulation group according to the predetermined random number list.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 30, 2021
• Study Start: October 15, 2022
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)