The goal of this study is to evaluate the change in pain scores among patients with chemotherapy-induced peripheral neuropathy after receiving treatment with repetitive transcranial magnetic stimulation (rTMS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Repetitive Transcranial Magnetic Stimulation will be administered Monday-Friday for two weeks (10 sessions total)
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States
RECRUITINGChange in Pain Numeric Rating Scale (PNRS) between screening and end of treatment in subjects who complete at least 7 rTMS treatments.
To assess the change in pain scores (0- no pain to 10-worst pain imaginable) after treatment with repetitive transcranial magnetic stimulation (rTMS) in patients with CIPN.
Time frame: 5 months
The rTMS therapy will be considered safe if the proportion of subjects reporting treatment related grade 3 adverse device effects per Common Terminology Criteria for Adverse Events (CTCAE 5.0) is less than or equal to 5%.
To evaluate the safety of open-label 10-Hz rTMS of the motor cortex in individuals with CIPN.
Time frame: 2 years
The rTMS therapy will be feasible if at least 70% of the treated subjects can complete at least 70% of the treatment sessions.
To evaluate the feasibility of 10 sessions of open-label 10-Hz rTMS of the motor cortex in individuals with CIPN.
Time frame: 2 years
Change in Pain Numeric Rating Scale (PNRS)
To evaluate the duration of pain (0- no pain to 10-worst pain imaginable) relief after treatment with rTMS.
Time frame: up to 12 weeks after initiation of study intervention
Change in Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29) v.2.1
To evaluate the change in patient-reported outcomes. Each question usually has five response options ranging in value from one to five. The raw score is the sum of the values of the response to each question. From the raw score, the T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. This outcome measure will report the mean T-scores of 8 subscales; Physical Function (Range: 22.5-57), Anxiety (40.3-81.6), Depression (41.0-79.4), Fatigue (33.7-75.8), Sleep Disturbance (32-73.3), Social Roles (27.5-64.2), Pain Interference (41.6-75.6), and Cognitive Function (29.5-61.2).
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Time frame: up to 12 weeks after initiation of the study intervention
Change in Brief Pain Inventory-Short Form (BPI-SF) Scores
To evaluate the change in patient-reported outcomes. This outcome measure will report two BPI-SF subscales. Pain Severity Score is the mean of 4 items. Scores range from 0-10, with lower scores indicating less pain and higher scores indicating more pain. Pain Interference Score is the mean of 7 items. Scores range from 0-10, with lower scores indicating less pain interference and higher scores indicating more pain interference. This outcome measure will report the mean of the Pain Severity and Pain Interference Scores.
Time frame: up to 12-week after initiation of the study intervention
Change in Patient's Global Impression of Change (PGIC) Score
To evaluate the change in patient-reported outcomes. The PGIC asks patients to rate how their pain has changed since the start of the study. This outcome measure will report the mean of the single-item, 7-point PGIC scale from 0 No change (or the condition has gotten worse) to 7 A great deal better, and considerable improvement that has made all the difference.
Time frame: up to 12-week after initiation of the study intervention
Change in EuroQol 5-Dimension, 5-Level (EQ-5D-5L)
To evaluate the change in patient-reported outcomes. The EQ-5D-5L assesses health status across five dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension is rated from Level 1 (no problems) to Level 5 (extreme problems). For analysis, each dimension will be dichotomized into two categories: No Problems (Level 1) Problems (Levels 2-5) The outcome measure will report the number of participants in each category for each health dimension.
Time frame: up to 12-week after initiation of the study intervention
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC-QLQ-CIPN-20)
To evaluate the change in patient-reported outcomes. The EORTC QLQ-CIPN20 is 20 items on a 1-4 Likert scale, where 1 is "not at all" and 4 is "very much". Items are summed to obtain the raw score, then converted to a 0-100 scale. Higher scores indicate more severe chemotherapy-induced peripheral neuropathy (CIPN), lower scores indicate less CIPN
Time frame: up to 12-week after initiation of the study intervention