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Study of Experience of High-frequency Repetitive Transcranial

R

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

Status

Completed

Conditions

Chronic Schizophrenia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05809882
RongjunHebei001

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

33 participants in 2 patient groups

the study group
Experimental group
Treatment:
Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
the control group
Active Comparator group
Treatment:
Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil
Device: Magstim RAPID2 neuromagnetic stimulator (Magstim) with an "8"-type coil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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