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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-03672 | Other Identifier | NCI-CTRP Clinical Registry |
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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.
Primary Objectives:
Objective 1 (Primary Objective): to examine preliminary baseline and serial electrophysiological markers associated with the onset and development of CIPN by tracking brain activity and CIPN symptoms throughout chemotherapy treatment.
Secondary Objectives:
Objective 2 (Secondary Objective): To preliminarily evaluate whether a clBCI program can regulate changes in EEG that are associated with CIPN while participants are undergoing chemotherapy.
Exploratory Objective: Explore whether there are associations between change in brain function and subjective report of CIPN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year. |
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Inclusion criteria:
Objective 1 Inclusion criteria
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:
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.
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Participants at MD Anderson Cancer Center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lorenzo Cohen, PHD | Contact | (713) 745-4260 | lcohen@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Cohen, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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