Understanding and Preventing Cortical Mechanisms of Chemotherapy-induced Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Participants at MD Anderson Cancer Center
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Electroencephalogram (EEG)
Diagnostic testMeasure the electrical activity of your brain before you receive chemotherapy treatment and once monthly for a maximum of 6 measurements.
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Cohort 1 - First 30 Participants1 intervention
Group B: Cohort 2 - Participants 31-451 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov