Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Morgan State University
Study ID
NCT06522685
Status
Not Yet Recruiting

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Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • transcranial direct current stimulation Soterix REMOTE 1x1 miniCT — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Feb 2025
Primary completion
Jan 31, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Left motor cortex targeted anodal transcranial direct current stimulation
    Active left motor cortex targeted anodal transcranial direct current stimulation at 2 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks.
  • Sham Comparator: Left motor cortex targeted sham transcranial direct current stimulation
    Active left motor cortex targeted anodal transcranial direct current stimulation at 0 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks. The sham consists of a ramp up to 2 mA and immediate ramp down to 0 mA at the beginning of the 20 minute period and a ramp up to 2 mA and immediate ramp down to 0 mA at the end of the 20 minute period.

Primary Outcome Measure

Number of participants able to adhere to the at home remote stimulation protocol [ Time Frame: 2 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cynthia RennBaltimoreMaryland21201
Cynthia Renn, PhD
[email protected]
410-706-5736
Morgan State UniversityBaltimoreMaryland21251
Timothy J Meeker, PhD
[email protected]
443-885-4468

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By research site
Cynthia Renn· Baltimore, MDMorgan State University· Baltimore, MD

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