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Completed

NCT Number: NCT05809882

Study of Experience of High-frequency Repetitive Transcranial

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.

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Key information

Conditions

Chronic Schizophrenia

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Baoding, Hebei, 071000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Self-experience checklist post- transcranial magnetic stimulation treatment

    Time frame: Half an hour

    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.

  2. positive and negative symptom scales (PANSS)

    Time frame: Half an hour

    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.

  3. The repeatable battery for the assessment of neuropsychological status

    Time frame: Half an hour

    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).

  4. The Insight and Treatment Attitudes Questionnaire (ITAQ)

    Time frame: Half an hour

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

High-frequency rTMS Therapy Experience

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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