Peripheral Neuropathy Clinical Trials

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Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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:

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

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Lorenzo Cohen, PHD
lcohen@mdanderson.org
(713) 745-4260
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 45
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov