Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06389721
Status
Recruiting
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Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electroencephalogram (EEG) — DIAGNOSTIC_TEST
    Measure the electrical activity of your brain before you receive chemotherapy treatment and once monthly for a maximum of 6 measurements.

Study Details

Cohort 1: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN). Cohort 2: To track the onset and progression of a condition called chemotherapy-induced peripheral neuropathy (CIPN) and to test a certain type of experimental neuromodulation (stimulation of the brain) with a device called a closed-loop brain-computer interface (clBCI) to see if can help to prevent pain due to CIPN.

Key Dates

Start date
Jul 16, 2024
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
45 participants (estimated)

Arms

  • Arm: Cohort 1 - First 30 Participants
    The first 30 participants make up Cohort 1. You will have an EEG and complete one questionnaire prior to your first dose of chemotherapy and once monthly until the end of your chemotherapy (for a maximum of 6 measurements).
  • Arm: Cohort 2 - Participants 31-45
    Participants 31-45 make up Cohort 2. You will have an EEG,and complete a questionnaire before and after your chemotherapy regimen. Participants will also have a treatment called closed-loop brain-computer interface (clBCI) training twice a week for the 2 weeks leading up to starting chemotherapy, and then twice a week during chemotherapy, for a maximum of 32 sessions, which you will be able to do at home.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Sarah Prinsloo, PHD
[email protected]
713-745-4260
Lorenzo Cohen, PHD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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