Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Recruiting now

Conditions studied: Chemotherapy-induced Peripheral Neuropathy

In brief

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 facts

Study ID

NCT06389721

Run by

M.D. Anderson Cancer Center

People needed

45

Starts

2024-07-16

Expected to finish

2027-01-31

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Objective 1 Inclusion criteria
• Participants must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
• ECOG Performance Status of 0-2;
• Willing to come to MD Anderson for the imaging sessions.
• Are 18 years of age or above.
• Have a diagnosis of breast cancer.
• will receive chemotherapy including doxorubicin, cyclophosphamide, docetaxel, or paclitaxel;
• Objective 2 Inclusion criteria:
• Inclusion criteria: Identical to Objective 1 and are willing to participate in the therapy sessions at their homes.

You may not qualify if…

• Objective 1 Exclusion criteria:
• Participants who are taking any antipsychotic medications.
• With active CNS disease, such as clinically evident metastases or leptomeningeal disease, dementia, or encephalopathy.
• Have ever been diagnosed with bipolar disorder or schizophrenia.
• Known, previously diagnosed peripheral neuropathy from any causes and
• A history of head injury or who have known seizure activity.
• Objective 2 Exclusion criteria
• Same exclusion criteria as in Objective1. Medication usage will be tracked for patients in all groups. Once prescribed, participants must remain on a stable course of medications throughout the course of chemotherapy.

Where it is running

• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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