Clinical trial NCT05809882: Study of Experience of High-frequency Repetitive Transcranial
Official title: High-frequency rTMS Therapy Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Schizophrenia
Lead sponsor: Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Self-experience checklist post- transcranial magnetic stimulation treatment
timeFrame: Half an hour
measure: positive and negative symptom scales (PANSS)
timeFrame: Half an hour
measure: The repeatable battery for the assessment of neuropsychological status
timeFrame: Half an hour
measure: The Insight and Treatment Attitudes Questionnaire (ITAQ)
timeFrame: Half an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Baoding
country: China
facility: Rongjun Hospital of Hebei Province Affiliated to North China University of Science and Technology
state: Hebei
Study officials:
References: