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Exploring Non-invasive Brain Stimulation for Chemotherapy-induced Neuropathy

This study is looking into a new way to help with painful nerve damage (chemotherapy-induced peripheral neuropathy or CIPN) that can happen after cancer treatment. Many people, especially Non-Hispanic Black patients, experience CIPN, and current treatments like duloxetine don't work for everyone. This trial is testing a device called Soterix Medical REMOTE Neuromodulation, which uses transcranial direct current stimulation (tDCS) to send gentle electrical currents to the brain. Researchers believe tDCS might help reduce pain by affecting how your brain processes pain. You might be able to join if you are 18 or older, can read English, are Non-Hispanic White or Non-Hispanic Black, and have painful CIPN that was diagnosed at least 3 months after your cancer treatment ended. The study will look at how well people can use the tDCS device at home and any side effects, as well as changes in brain structure.

Study design
This is an interventional study planning to enroll 80 participants. The study will test the Soterix Medical REMOTE Neuromodulation device.
What's involved
The study will measure your ability to use the at-home stimulation protocol and any side effects over 2 weeks. Cortical thickness will be measured at 10 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at 2 weeks and 10 minutes after certain procedures.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06522685

Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation

Not Yet Recruiting
NAAges 18+InterventionalDevice feasibility
Morgan State University
~80 participants
Updated 2025-02-06 on ClinicalTrials.gov
What's tested:transcranial direct current stimulation Soterix REMOTE 1x1 miniCT

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants able to adhere to the at home remote stimulation protocol
Measured over 2 weeks
+5 more outcomes measured

Conditions

Chemotherapy-induced Peripheral Neuropathy

Explore related trials

Chemotherapy-Induced Peripheral Neuropathy

Where it's being run

2 sites across 1 states
Maryland2

Who to contact

Timothy J Meeker, PhD
[email protected]
443-885-4468
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Able to read, write, and comprehend English
Non-Hispanic White or Non-Hispanic Black
Stable medication dosage over previous 4 weeks
Completed primary surgery or chemotherapy for cancer at least 3 months prior to signing consent form
Diagnosed with painful chemotherapy-induced neuropathy

Exclusion

Chronic pain due to another painful condition (e.g., fibromyalgia, chronic low back pain, etc.)
Any neurological deficits (e.g., lower extremity weakness or bowel/bladder dysfunction, etc.)
Deficient folate levels (\<7 nmol/ml serum)
Deficient vitamin B12 levels (\<200 pg/mL serum)
Deficient Vitamin D levels (\<50 nmol/L or \<20 ng/ml)
Comorbidities affecting sensorimotor function (e.g., multiple sclerosis, diabetes, etc.)
Unstable mental health condition (acute medical management/hospitalization in the past 6 mo.)
Elevated hemoglobin A1c levels indicative of uncontrolled diabetes (\>6.5%)
Self-reported Substance abuse (current)
Drug test positive for illicit drugs except THC
Excessive alcohol consumption defined as: 1) More than 3 glasses of wine a day; 2) More than 3 beers a day; 3) More than 60 mL of hard liquor a day
Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD).
Pregnancy, lactation (will be screened with urine pregnancy test)
Non-removable metal or tattoos around head, excepting dental appliances and fillings
Use of implantable copper birth control device
History of frequent severe headaches
Unstable coronary artery disease
Uncontrolled Seizure disorder
Uncontrolled hypertension
Stage IV cancer

What this trial measures

  • Number of participants able to adhere to the at home remote stimulation protocol2 weeks

    Number of participants able to adhere to the at home study protocol comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups

  • Number of side effects reported on the transcranial direct current stimulation side effect questionnaire2 weeks

    Number of side effects reported on the transcranial direct current stimulation side effect questionnaire comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups (n=20 per group; 4 groups)

  • Cortical thickness10 minutes

    Cortical thickness comparison between non-Hispanic blacks and non-Hispanic whites

  • Blood oxygen level dependent (BOLD) response to sharp mechanical stimuli10 minutes

    Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy

  • Blood oxygen level dependent (BOLD) response to painful heat stimuli10 minutes

    Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy

  • Blood oxygen level dependent (BOLD) response to cold heat stimuli10 minutes

    Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy