Study of Experience of High-frequency Repetitive Transcranial

High-frequency rTMS Therapy Experience

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.

Study Overview

• Status: Completed
• Conditions: Chronic Schizophrenia
• Intervention / Treatment: Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil; Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil

Detailed Description

The investigators recruited male subjects admitted to who met the criteria. They were divided into a control and a treatment group. A double-blind approach was adopted. The subjects were unaware of whether real/pseudo stimulation was applied, and the evaluators did not know the grouping specifics. All of the enrolled cases were tested for stimulation thresholds in the bilateral prefrontal cortex. The TMS treatment device was a Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil. The study group was administered real stimulation. The treatment parameters were as follows: 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. For the control group, a 60% motion threshold was set; the remaining parameters were consistent with the study group but with no stimulating energy output. The therapeutic instrument model, appearance, operation process, and sounds when effecting treatment were the same for both groups. A self-experience checklist post-TMS treatment and positive and negative symptom scales (PANSS) were applied to evaluate the treatment.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Baoding, Hebei, China, 071000
      • Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1) were aged 18-65 years;
• 2) fulfilled the diagnosis of International Classification of Diseases Edition 10 schizophrenia;
• 3) had been diagnosed with schizophrenia more than five years previously;
• 4) were in a stable condition;
• 5) whose medication remained unchanged during treatment;
• 6) who did not have a history of epilepsy (including drug-derived);
• 7) had no brain trauma or surgery history;
• 8) who accepted treatment voluntarily and provided signed informed consent for inclusion in the study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the control group	Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil; 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; Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil; frequency range, 20 Hz，60% 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. But with no stimulating energy output.
Experimental: the study group	Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil; 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; Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil; frequency range, 20 Hz，60% 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. But with no stimulating energy output.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: RongjunHebei001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No