NCT03219502

rTMS in Improving Neuropathy in Patients With Stage I-IV Cancer Who Have Received Oxaliplatin Chemotherapy

Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat Oxaliplatin-Induced Neuropathy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well repetitive transcranial magnetic stimulation (rTMS) works in improving neuropathy due to oxaliplatin chemotherapy in patients with stage I-IV cancer. rTMS is designed to change brain activity by introducing small magnetic impulses to the scalp that encourage the brain to change its activity.

Detailed description

PRIMARY OBJECTIVES: I. Examine the effects of the repetitive transcranial magnetic stimulation (rTMS) training program on perceptions of chemotherapy-induced peripheral neuropathy (CIPN) versus placebo (PC) and wait-list control groups (WLC). SECONDARY OBJECTIVES: I. Explore changes in cortical activity: Electroencephalography (EEG) brain maps (low resolution electromagnetic tomography) will be assessed over time and compared between groups. II. Determine if rTMS improves other aspects of CIPN, quality of life (QOL), and mental health (MH) compared to PC and WLC. III. Explore moderators/mediators of the intervention by examining the extent to which changes in EEG patterns mediate the effects of the intervention and the extent to which there are interaction effects of the intervention and each of the baseline brain regions. OUTLINE: Patients are randomized to 1 of 3 groups. GROUP I: Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days. GROUP II: Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days. GROUP III: Patients receive standard of care. After completion of study, patients are followed up within 1 week and at 1 month.

Conditions

• Malignant Neoplasm
• Neuropathy

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Repetitive Transcranial Magnetic Stimulation	Undergo rTMS
PROCEDURE	Sham Intervention	Undergo sham rTMS

Timeline

• Start date: 2017-07-10
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2017-07-17
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States