Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation
NCT Number: NCT06522685
Acronym: NIBS4CIPN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Interventions: DEVICE: transcranial direct current stimulation Soterix REMOTE 1x1 miniCT
Sponsor: Morgan State University
Collaborators: University of Maryland, Baltimore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-09-01
Completion Date: 2029-06-30
Locations: Cynthia Renn, Baltimore, Maryland, 21201, United States|Morgan State University, Baltimore, Maryland, 21251, United States

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.

Primary Outcome Measures: Number of participants able to adhere to the at home remote stimulation protocol, Number of participants able to adhere to the at home study protocol comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups, 2 weeks|Number of side effects reported on the transcranial direct current stimulation side effect questionnaire, Number of side effects reported on the transcranial direct current stimulation side effect questionnaire comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups (n=20 per group; 4 groups), 2 weeks|Cortical thickness, Cortical thickness comparison between non-Hispanic blacks and non-Hispanic whites, 10 minutes|Blood oxygen level dependent (BOLD) response to sharp mechanical stimuli, Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy, 10 minutes|Blood oxygen level dependent (BOLD) response to painful heat stimuli, Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy, 10 minutes|Blood oxygen level dependent (BOLD) response to cold heat stimuli, Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy, 10 minutes
Secondary Outcome Measures: Brief pain inventory short form score, Comparing active to sham transcranial direct current stimulation in non-Hispanic black participants and non-Hispanic white participants, 2 weeks|Brief pain inventory short form score, Comparing active to sham transcranial direct current stimulation in non-Hispanic black participants and non-Hispanic white participants, At 6 week follow-up