임상시험 레이더

Visual analogue scale

It typically consists of a 10-centimeter straight line, with two endpoints representing extreme states of the measured experience. For example, when assessing pain, one end is labeled "0 (no pain at all)" and the other end "10 (worst pain imaginable, unbearable)". The individual being evaluated marks a point on the line that corresponds to their current experience. The score is determined by measuring the distance from this mark to the "0" end, converted into a numerical value ranging from 0 to 10 (where each centimeter equals 1 point). Higher scores indicate a stronger intensity of the experience.

Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention

short-form McGill Pain Questionnaire (SF-MPQ)

The Short-Form McGill Pain Questionnaire (SF-MPQ) is a concise, widely used tool designed to assess the nature and intensity of pain in a efficient manner. Key Components: * Sensory pain descriptors (11 items): These words capture the physical qualities of pain, such as "throbbing," "burning," "aching," and "sharp." Respondents rate each on a scale of 0 (none) to 3 (severe). * Affective pain descriptors (4 items): These reflect the emotional aspects of pain, including "tiring," "fearful," "punishing/cruel," and "worrying." They are also rated 0-3. * Visual Analog Scale (VAS): A 10-centimeter line with endpoints labeled "no pain" and "worst imaginable pain." Patients mark a point along the line to indicate their pain intensity. * Present Pain Intensity (PPI): A 6-point scale (0-5) ranging from "no pain" (0) to "excruciating" (5), used to rate the current level of pain.

Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention

7-item pain interference scale of the Brief Pain Inventory (BPI)

* Items assessed: The 7 items evaluate how pain interferes with: * General activity * Mood * Walking ability * Normal work (including both work outside the home and housework) * Relationships with others * Sleep * Enjoyment of life * Rating scale: Each item is rated on an 11-point numerical scale (0 = "does not interfere" to 10 = "interferes completely"), based on the past 24 hours.

Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention

The Patient Global Impression of Change (PGIC)

* Single-item structure: It consists of a single question that asks patients to rate how much their condition has changed since a specified baseline (e.g., "Since starting treatment, how would you rate your overall change in pain?"). * 7-point response scale: Responses range from "very much improved" (score 1) to "very much worse" (score 7), with intermediate options including "much improved," "minimally improved," "no change," "minimally worse," and "much worse." * Subjective and holistic: It captures the patient's personal, global judgment rather than focusing on specific symptoms, reflecting their integrated experience of change.

Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention

The 17-item Hamilton Depression Rating Scale (HAMD-17)

It includes 17 items covering core depressive symptoms and related manifestations, mainly involving the following dimensions: * Emotional symptoms: Such as depressed mood, feelings of guilt, suicidal ideation, etc. * Somatic symptoms: Including difficulty falling asleep, difficulty maintaining sleep, early awakening, reduced work and interests, retardation (psychomotor), agitation (psychomotor), somatic anxiety, gastrointestinal symptoms, general symptoms, sexual symptoms, etc. * Other related symptoms: Such as weight loss, insight, delusional or obsessive symptoms, depersonalization or derealization, paranoid symptoms, compulsive symptoms, etc. (Some items vary slightly according to versions, with the core being emotional and somatic manifestations related to depression).

Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention

The Beck Depression Inventory-II (BDI-II)

The Beck Depression Inventory-II (BDI-II) is a widely used self-report questionnaire designed to assess the severity of depressive symptoms in adults and adolescents. It consists of 21 items, each describing a specific depressive symptom (e.g., sadness, loss of interest, guilt, fatigue, sleep disturbances, appetite changes).

Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention

TMS-EEG

TMS-EEG (Transcranial Magnetic Stimulation-Electroencephalography) is a combined neuroimaging technique that synchronously uses TMS to non-invasively stimulate specific brain regions and EEG to record the brain's electrical activity responses to this stimulation.

Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group