Status:
NOT_YET_RECRUITING
Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation
Lead Sponsor:
Morgan State University
Collaborating Sponsors:
University of Maryland, Baltimore
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 mo...
Detailed 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 ...
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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06522685
Start Date
March 1 2025
End Date
June 30 2029
Last Update
February 6 2025
Active Locations (2)
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1
Cynthia Renn
Baltimore, Maryland, United States, 21201
2
Morgan State University
Baltimore, Maryland, United States, 21251