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rTMS for Neuropathy in Cancer Patients

N/A

Waitlist Available

Led By Sarah Prinsloo

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No plans to change the type of pain medication (if a patient is on pain medication)

Grade 2 or higher neuropathic symptoms according to the National Cancer Institute's 4 point grading scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 1 month

Awards & highlights

Study Summary

This trial studies the use of rTMS to improve neuropathy caused by oxaliplatin chemotherapy. rTMS is a noninvasive procedure that uses magnetic impulses to stimulate the brain and change its activity.

Who is the study for?

This trial is for English-speaking stage I-IV cancer patients who've had oxaliplatin chemotherapy and suffer from moderate to severe neuropathy. They must be stable on pain meds, able to visit MD Anderson for sessions, have an ECOG status of 0-2, and their neuropathy should be at least 3 months old. Excluded are those with bipolar disorder or schizophrenia, brain implants or pacemakers not MRI safe, antipsychotic use, brain metastases or CNS disease, head injury history, known seizures, or drug withdrawal.Check my eligibility

What is being tested?

The study tests if rTMS can improve chemotherapy-induced neuropathy in cancer patients. It involves small magnetic pulses applied to the scalp aimed at altering brain activity. Participants will either receive this intervention or a sham (fake) treatment as part of the control group while continuing their usual care routines.See study design

What are the potential side effects?

rTMS may cause discomfort at the site of stimulation on the scalp, headache during initial treatments which usually diminishes over time; rare risks include seizure induction especially in predisposed individuals but overall it's considered a low-risk procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not planning to change my current pain medication.

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I experience moderate to severe nerve pain or tingling.

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I have had nerve pain symptoms for at least 3 months.

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I have received oxaliplatin chemotherapy for my stage I-IV cancer.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in perceptions of chemotherapy-induced peripheral neuropathy (CIPN)

Secondary outcome measures

Change in cortical activity

Change in perception of improvement in CIPN as assessed by Brief Pain Inventory-short form (BPI) questionnaire

Change in perception of improvement in CIPN as assessed by Edmonton Symptom Assessment System (ESAS) questionnaire

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Group I (rTMS)Experimental Treatment3 Interventions

Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.

Group II: Group III (standard of care)Active Control3 Interventions

Patients receive standard of care.

Group III: Group II (sham rTMS)Placebo Group3 Interventions

Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Repetitive Transcranial Magnetic Stimulation

2013

Completed Phase 3

~1170

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,746 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,611 Total Patients Enrolled

Sarah PrinslooPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

794 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots to join this medical research?

"According to the data hosted on clinicaltrials.gov, this trial is not presently seeking volunteers; since its first posting in July of 2017 and most recent update on June 29th 2022, no new participants have been recruited. However, 2550 other medical studies across various disciplines are actively enrolling patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "rTMS in Improving Neuropathy in Patients With Stage I-IV Cancer Who Have Received Oxaliplatin Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03219502.

All > Neuropathy