Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex S… (NCT06522685) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation
United States80 participantsStarted 2025-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Histor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants able to adhere to the at home remote stimulation protocol
Timeframe: 2 weeks
2
Number of side effects reported on the transcranial direct current stimulation side effect questionnaire
Timeframe: 2 weeks
3
Cortical thickness
Timeframe: 10 minutes
4
Blood oxygen level dependent (BOLD) response to sharp mechanical stimuli
Timeframe: 10 minutes
5
Blood oxygen level dependent (BOLD) response to painful heat stimuli
Timeframe: 10 minutes
6
Blood oxygen level dependent (BOLD) response to cold heat stimuli