Recruiting

Peripheral Neuropathy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06389721

Conditions

Chemotherapy-induced Peripheral Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electroencephalogram (EEG)

Study Details

Brief summary:

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Study ID

NCT06389721

Start date

Jul 16, 2024

Status verified date

May, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

Objective 1 Inclusion criteria

1. Participants must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements.
2. ECOG Performance Status of 0-2;
3. Willing to come to MD Anderson for the imaging sessions.
4. Are 18 years of age or above.
5. Have a diagnosis of breast cancer.
6. will receive chemotherapy including doxorubicin, cyclophosphamide, docetaxel, or paclitaxel;

Objective 2 Inclusion criteria:

1\) Inclusion criteria: Identical to Objective 1 and are willing to participate in the therapy sessions at their homes.

Exclusion Criteria

Objective 1 Exclusion criteria:

1. Participants who are taking any antipsychotic medications.
2. With active CNS disease, such as clinically evident metastases or leptomeningeal disease, dementia, or encephalopathy.
3. Have ever been diagnosed with bipolar disorder or schizophrenia.
4. Known, previously diagnosed peripheral neuropathy from any causes and
5. A history of head injury or who have known seizure activity.

Objective 2 Exclusion criteria

1\) 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.

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

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.

Interventions

Electroencephalogram (EEG)

Measure the electrical activity of your brain before you receive chemotherapy treatment and once monthly for a maximum of 6 measurements.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Lorenzo Cohen, PHD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 19, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-19.