Neural and Immune Correlates of Painful Chemotherapy-Induced Neuropathy, Feasibility and Preliminary Efficacy of a Motor Cortex Non-Invasive Brain Stimulation Intervention
Morgan State University
Summary
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.
Description
More than half of patients treated with commonly used platinum- and taxane-based anti-cancer agents suffer painful chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients have a greater risk (risk ratio=1.6-2.4) of experiencing clinically relevant CIPN and consequent chemotherapy dose reductions compared to non-Hispanic Whites (NHWs). Despite the greater risk of painful CIPN in NHB cancer patients, clinical trials in patients suffering with CIPN have historically included homogeneous patient populations of NHWs. Only duloxetine is approved to treat painful CIPN and…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- Devicetranscranial direct current stimulation Soterix REMOTE 1x1 miniCT
Soterix Medical REMOTE Neuromodulation is the only system with device, accessories, and software designed for deployed use. Safe transcranial Electrical Stimulation requires advanced systems designed for consistency and control. REMOTE Neuromodulation is the only system designed from the ground up to allow translation of clinical tES, including tDCS protocols, to diverse deployed environments, while maintaining medical standards.
Locations (2)
- Cynthia RennBaltimore, Maryland
- Morgan State UniversityBaltimore, Maryland