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Study of Experience of High-frequency Repetitive Transcranial

High-frequency rTMS Therapy Experience

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05809882
Enrollment
33
Registered
2023-04-12
Start date
2019-03-01
Completion date
2020-02-20
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Schizophrenia

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.

Interventions

DEVICEMagstim 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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Self-experience checklist post- transcranial magnetic stimulation treatmentHalf an hourSelf-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)Half an hourIt 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 statusHalf an hourThe 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)Half an hourit includes the subject's understanding of the disease and their attitude towards treatment. A higher score indicated that a patient had better self-knowledge.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026