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Study of Experience of High-frequency Repetitive Transcranial

Primary Purpose

Chronic Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
Sponsored by
Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the study group

the control group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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).
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.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2023
Last Updated
March 30, 2023
Sponsor
Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05809882
Brief Title
Study of Experience of High-frequency Repetitive Transcranial
Official Title
High-frequency rTMS Therapy Experience
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the study group
Arm Type
Experimental
Arm Title
the control group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-experience checklist post- transcranial magnetic stimulation treatment
Description
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.
Time Frame
Half an hour
Title
positive and negative symptom scales (PANSS)
Description
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.
Time Frame
Half an hour
Title
The repeatable battery for the assessment of neuropsychological status
Description
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).
Time Frame
Half an hour
Title
The Insight and Treatment Attitudes Questionnaire (ITAQ)
Description
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.
Time Frame
Half an hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China

12. IPD Sharing Statement

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Study of Experience of High-frequency Repetitive Transcranial

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