Klinische Studien Radar

Mean Change in Primary Motor Cortex (M1) Connectopy Profile

Resting-state fMRI will be used to derive connectopy embeddings of the primary motor cortex (M1). Connectopy embeddings from the stimulated side will be extracted from significant baseline-defined clusters. A single value per participant is derived by averaging the embedding values within this cluster. Higher scores indicate increased similarity to healthy reference profiles (improved functional connectivity), while lower scores indicate deviation from healthy reference patterns (reduced functional connectivity).

Baseline and post-treatment (after 10 sessions of rTMS over 2 weeks).

Mean Change in Pain Intensity (Numeric Rating Scale, NRS)

Self-reported average pain over 7 days using the Numeric Rating Scale (0 = "no pain at all" to 10 = "worst pain possible"). A single number is derived as the mean of daily ratings over 7 days. Lower scores indicate reduced pain intensity, while higher scores indicate worse pain intensity.

Baseline and post-treatment (following 10 rTMS sessions, within 7 days of completing rTMS sessions ).

Mean Change in Pressure Pain Threshold (PPT)

Pressure pain threshold (PPT) will be measured using a pressure algometer (Wagner Inc.). Pressure will be applied at a constant rate until participants indicate pain perception. The threshold (kg/cm²) will be recorded. A single value is derived by averaging three threshold readings from the target site. Higher thresholds indicate reduced pain sensitivity (improvement), while lower thresholds indicate increased pain sensitivity (worsening).

Baseline and post-treatment (within 7 days of completing rTMS sessions )

Mean Change in Fatigue (Patient-Reported Outcomes Measurement Information System-PROMIS Fatigue 13a Subscale)

Fatigue will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue 13a subscale, which ranges from 13 to 65. Higher scores indicate greater fatigue severity (worsening), whereas lower scores indicate less fatigue (improvement).

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in Sleep Disturbance (Patient-Reported Outcomes Measurement Information System - PROMIS Sleep Disturbance 8a Subscale)

Sleep disturbance will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance 8a subscale, which ranges from 8 to 40. Higher scores indicate greater sleep disturbance (worsening), whereas lower scores indicate improved sleep.

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in the Short-Form McGill Pain Questionnaire

The Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) has 22 items assessing continuous, intermittent, neuropathic, and affective pain. Items are rated 0-10, with total scores ranging 0-220, where higher scores indicate greater pain severity.

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in Central Sensitization Index

Central Sensitization Index (CSI) is a 25-item self-reported measure that determines whether the symptoms of patients are associated with central sensitization. Item responses are on a 4-point scale and can be answered as follows: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, and 4 = Always. The total score will be used to estimate the severity of the central sensitization symptoms.

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in Pain Catastrophizing Scale

The Pain Catastrophizing Scale (PCS) has 13 items measuring rumination, magnification, and helplessness related to pain. Items are rated 0-4, with total scores ranging 0-52; higher scores indicate greater catastrophizing.

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in the Pain Self-repot Survey for the Assessment of Fibromyalgia

The Patient Self-Report Survey for the Assessment of Fibromyalgia has 9 items measuring widespread pain and symptom severity. Scores range 0-31, with higher scores indicating greater fibromyalgia symptom burden.

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in Revised Fibromyalgia Impact Questionnaire

The Revised Fibromyalgia Impact Questionnaire (FIQR) is a 21-item, three-domain, self-reported measure of the impact of fibromyalgia on life. All questions include a 0-10 scale, and different domains have different calculations (function domain divided by 3, overall impact domain divided by 1, symptom domain divided by 2) before summing all scores. The total score will be used to estimate the changes in quality of life with interventions.

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in Pittsburgh Sleep Quality Index (PSQI)

The Pittsburgh Sleep Quality Index (PSQI) measures sleep quality over the past month and consists of seven components assessing various aspects of sleep quality and sleep-related daytime functioning. The index will be used to estimate the overall sleep quality of participants, with total scores ranging from 0 to 21, where higher scores indicate worse sleep quality.

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in Chronic Overlapping Pain Conditions Screener

Chronic Overlapping Pain Conditions Screener (COPCS) is a self-report tool that uses a body map and trigger questions to screen for 10 chronic overlapping pain conditions and outputs the number of conditions present (0-10).

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in Hospital Anxiety and Depression Scale

The Hospital Anxiety and Depression Scale (HADS) has 14 items, 7 each for anxiety and depression. Each item is rated 0-3, with subscale scores ranging 0-21; higher scores indicate greater symptom severity.

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in Beck Depression Inventory

The Beck Depression Inventory (BDI) has 21 items assessing depressive symptoms. Each item is rated 0-3, with total scores ranging 0-63; higher scores indicate greater depression severity.

Baseline and post-treatment (within 7 days of completing rTMS sessions).

Mean Change in Beck Anxiety Inventory

The Beck Anxiety Inventory (BAI) has 21 items assessing anxiety symptoms. Each item is rated 0-3, with total scores ranging 0-63; higher scores indicate greater anxiety severity.

Baseline and post-treatment (within 7 days of completing rTMS sessions).