Study of Experience of High-frequency Repetitive Transcranial

NCT ID: NCT05809882

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-02-20

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.

Conditions

Chronic Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the study group

Group Type: EXPERIMENTAL

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

Intervention Type: 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

the control group

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

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.

Interventions

Magstim 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

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Xinfu Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Baoding, Hebei, China

Countries

China

Other Identifiers

RongjunHebei001

Identifier Type: -

Identifier Source: org_study_id