rTMS for Postoperative Brain Tumor Patients

Safety will be determined by the rate of adverse events that occur within one week following completion of the transcranial magnetic stimulation protocol. Adverse events (AEs) and serious adverse events (SAEs) will be reported, along with their 95% confidence intervals.

Feasibility, as assessed by initial motor recovery, will be measured by participants' British Medical Research Council (MRC) score one week after protocol completion. For the primary feasibility endpoint, mean MRC scores will be reported before and one week after protocol completion. The MRC score ranges from 0 to 5, with a higher score indicating better muscle strength. A paired t-test will be used to determine whether the mean MRC score significantly increases after the TMS treatment. A 20-point increase is anticipated in the mean MRC score one week after protocol completion compared to before TMS treatment. Assuming a pooled standard deviation of 15 points, the test has a power of 0.87 to reject the null hypothesis with 6 evaluable patients and a significance level of 0.05.

Efficacy of transcranial magnetic stimulation on motor recovery as assessed by change from baseline in the Medical Research Council (MRC) Scale for Muscle Strength. The MRC Scale ranges from Grade 0 (no visible contraction) to Grade 5 (normal muscle strength), with a higher score indicating better muscle strength. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.

Efficacy of transcranial magnetic stimulation on motor recovery as assessed by change from baseline in The 10-Meter Walk Test (10MWT). The 10MWT measures short-distance walking speed in meters/second over a distance of six meters. Higher speeds indicate better functional mobility, vestibular function, and gait. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.

Efficacy of transcranial magnetic stimulation on motor recovery as assessed by change from baseline in the Box and Block Test (BBT). The BBT measures unilateral gross manual dexterity and is scored based upon the number of blocks a participant can transfer from one compartment of a box to another compartment within 60 seconds. Higher scores indicate better motor function in gross manual dexterity. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.

Efficacy of transcranial magnetic stimulation on motor recovery as assessed by change from baseline in the Barthel Index (BI). The BI measures ability to perform activities of daily living (ADLs) and mobility on a ten-item scale: (1) feeding, (2) bathing, (3) grooming, (4) dressing, (5) bowel continence, (6) bladder continence, (7) toilet use, (8) transfers from bed to chair and back, (9) mobility on level surfaces, and (10) mobility on stairs. The total score range is 0 to 100 across all 10 domains, with lower scores indicating greater dependency or impaired functional status. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.

Efficacy of transcranial magnetic stimulation on quality of life as assessed by change from baseline in the QLQ-BN20 questionnaire. The QLQ-BN20 is a quality-of-life survey validated for use in patients with brain tumors. The QLQ-BN20 consists of four multi-item scales: (1) future uncertainty (four items), (2) visual disorder (three items), (3) motor dysfunction (three items), and (4) communication deficit (three items). All items and scale scores are linearly transformed onto a 0 to 100-point scale, with higher scores signifying more severe symptoms and lower quality of life. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.

Efficacy of transcranial magnetic stimulation on quality of life as assessed by change from baseline in the Functional Assessment of Cancer Therapy - Brain (FACT-Br). The FACT-Br consists of the core FACT-General (FACT-G) questionnaire assessing more general domains of quality-of-life in addition to the brain tumor-specific scale. A total of 50 items is included across the following subscales: (1) physical well-being, (2) social/family wellbeing, (3) emotional well-being, (4) functional well-being, and (5) disease-specific concerns. Participants indicate the presence/severity of symptoms on a 5-point Likert Scale (0 to 4), with higher scores indicating more present/severe symptoms and lower quality of life. The total score range is 0 to 200. Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.

Efficacy of transcranial magnetic stimulation on quality of life as assessed by change from baseline in the EQ-5D-5L. The EQ-5D-5L is a validated instrument that assesses quality of life using self-reported profile data and a subjective visual scale to capture participants' perceptions of their own health. The EQ-5D-5L profile data is measured across five dimensions: (1) mobility, (2) usual activities, (3) self-care, (4) pain and discomfort, and (5) anxiety and depression. Each dimension is measured on a 5-point Likert scale, with 1 indicating no issues in a particular domain and 5 indicating extreme issues. Scores across all five dimensions form a five-digit "value set," which are then converted to a single number (i.e., EQ-5D values) using a weighting system. The total score ranges from 0 (indicating death) to 1 (indicating full health). Scores will be recorded pre-intervention and then at 1 week, 1 month, 3 months, and 6 months post-intervention.