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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Chemotherapy-induced Peripheral Neuropathy

In brief

Over half of cancer patients receiving common chemotherapy treatments experience painful nerve damage called chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients are more likely to suffer from this condition and more often need to reduce their chemotherapy doses compared to Non-Hispanic White (NHW) patients. Currently, only one medication, duloxetine, is approved for treating CIPN, but it doesn't work for everyone. A new approach, transcranial direct current stimulation (tDCS), shows promise as a safe and effective treatment. tDCS can be done at home and reduces the need for hospital visits. Research indicates that tDCS can improve pain responses in the brain's pain control network. There are differences in pain sensitivity and brain activity related to pain between NHB and NHW individuals, which may influence the effectiveness of treatments. This research aims to conduct a study to: 1. Test if tDCS is a helpful treatment for painful CIPN. 2. Investigate how CIPN affects brain function in NHB and NHW patients. 3. Examine the role of inflammation in CIPN and its connection to pain severity and brain function. The investigators expect that NHB patients will benefit more from tDCS due to differences in their brain's pain response system. This project aims to address health disparities and improve outcomes for urban communities, particularly in Baltimore.

Key facts

Study ID: NCT06522685
Run by: Morgan State University
People needed: 80
Starts: 2025-03-01
Expected to finish: 2029-06-30
Last updated by the study team: 2025-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Cynthia Renn — Baltimore, Maryland, United States
Morgan State University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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