Study of Experience of High-frequency Repetitive Transcranial

NCT05809882 | Completed

• 1 other identifier: RongjunHebei001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To understand the personal experience of schizophrenia patients following repetitive transcranial magnetic stimulation (rTMS) and its connection with changes in mental symptoms, thereby enhancing the overall understanding of TMS. Method: The investigators selected eligible schizophrenia patients for fixed-parameter rTMS treatment. A self-experience checklist post-TMS treatment and positive and negative symptom scales (PANSS) were applied to evaluate the treatment.

Conditions

Chronic Schizophrenia

Outcome Measures

Primary Outcomes (4)

• Self-experience checklist post- transcranial magnetic stimulation treatment

  Self-experience checklist post- transcranial magnetic stimulation treatment: In the present study, "self-experience" refers to an evaluation of the changes in a patient's self-perception before and after TMS treatment.

  Half an hour

• positive and negative symptom scales (PANSS)

  It included 30 entries, among which seven were positive, seven were negative, and the remaining 16 entries were general psychopathology scales for assessing the overall severity of schizophrenia using a 7-level score.

  Half an hour

• The repeatable battery for the assessment of neuropsychological status

  The RBANS scale included 12 test items that were summarized into five sets of neuromental states (five factors), i.e., immediate memory (vocabulary learning and story review), visuospatial structure (graphic depiction and line positioning), language (picture-naming and semantic fluency), attention (digital breadth and symbolic numbers), and delayed memory (vocabulary recall, vocabulary ecognition, story recall, and graphic recall).

  Half an hour

• The Insight and Treatment Attitudes Questionnaire (ITAQ)

  it includes the subject's understanding of the disease and their attitude towards treatment. A higher score indicated that a patient had better self-knowledge.

  Half an hour

Study Arms (2)

the study group

EXPERIMENTAL

Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil

the control group

ACTIVE COMPARATOR

Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil

Interventions

Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil DEVICE

frequency range, 20 Hz; 90% motion threshold; 3 s of stimulation; a 57 s interval; 15 min of stimulation for each side, five times per week for a total of 20 times

the study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) were aged 18-65 years;
• \) fulfilled the diagnosis of International Classification of Diseases Edition 10 schizophrenia;
• \) had been diagnosed with schizophrenia more than five years previously;
• \) were in a stable condition;
• \) whose medication remained unchanged during treatment;
• \) who did not have a history of epilepsy (including drug-derived);
• \) had no brain trauma or surgery history;

You may not qualify if:

• \) showed contraindications to rTMS intervention;
• \) had other neuropsychiatric disorders;
• \) received non-convulsive electroshock treatment a month preceding the start of the study;
• \) indicated an impulse for attacking actions and engaged in destructive and self-harming behavior;
• \) experienced generalized or electricity-related delusionsof reference,influence, andpersecution.

Sponsors & Collaborators

• Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology: lead

Study Sites (1)

Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology

Baoding, Hebei, 071000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 12, 2023
• Study Start: March 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: February 20, 2020
• Last Updated: April 12, 2023

Record last verified: 2023-03

Locations

CN (1)