Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation
Not yet recruitingNot applicableNCT06522685
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Neural and Immune Correlates of Painful Chemotherapy-Induced Neuropathy, Feasibility and Preliminary Efficacy of a Motor Cortex Non-Invasive Brain Stimulation Intervention
- Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Interventions
- Device: transcranial direct current stimulation Soterix REMOTE 1x1 miniCT
- Sponsor
- Morgan State University
- Collaborators
- University of Maryland, Baltimore
- Start date
- 2025-03-01
- Primary completion
- 2029-01-31
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06522685