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Neural and Immune Correlates of CIPN and Possible Analgesic Effect of Non-invasive Motor Cortex Stimulation

NCT ID: NCT06522685
Registry status: Not yet recruiting
Study type: Interventional
Phase: Not applicable
Sponsor: Morgan State University
Conditions: Chemotherapy-induced Peripheral Neuropathy

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: Neural and Immune Correlates of Painful Chemotherapy-Induced Neuropathy, Feasibility and Preliminary Efficacy of a Motor Cortex Non-Invasive Brain Stimulation Intervention

Enrollment: 80 participants (Estimated).

What is being studied

Intervention: Behavioral Disciplines and Activities
Intervention: Convulsive Therapy
Intervention: Electric Stimulation Therapy
Intervention: Electroshock
Intervention: Psychiatric Somatic Therapies
Intervention: Psychological Techniques
Intervention: Therapeutics
Intervention: Transcranial Direct Current Stimulation
Device: transcranial direct current stimulation Soterix REMOTE 1x1 miniCT

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: Yes

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Able to read, write, and comprehend English * Non-Hispanic White or Non-Hispanic Black * Stable medication dosage over previous 4 weeks * Completed primary surgery or chemotherapy for cancer at least 3 months prior to signing consent form * Diagnosed with painful chemotherapy-induced neuropathy Exclusion Criteria: * Chronic pain due to another painful condition (e.g., fibromyalgia, chronic low back pain, etc.) * Any neurological deficits (e.g., lower extremity weakness or bowel/bladder dysfunction, etc.) * Deficient folate levels (\<7 nmol/ml serum) * Deficient vitamin B12 levels (\<200 pg/mL serum) * Deficient Vitamin D levels (\<50 nmol/L or \<20 ng/ml) * Comorbidities affecting sensorimotor function (e.g., multiple sclerosis, diabetes, etc.) * Unstable mental health condition (acute medical management/hospitalization in the past 6 mo.) * Elevated hemoglobin A1c levels indicative of uncontrolled diabetes (\>6.5%) * Self-reported Substance abuse (current) * Drug test positive for illicit drugs except THC * Excessive alcohol consumption defined as: 1) More than 3 glasses of wine a day; 2) More than 3 beers a day; 3) More than 60 mL of hard liquor a day * Presence of cardiac pacemaker or automatic implantable cardioverter-defibrillator (AICD). * Pregnancy, lactation (will be screened with urine pregnancy test) * Non-removable metal or tattoos around head, excepting dental appliances and fillings * Use of implantable copper birth control device * History of frequent severe headaches * Unstable coronary artery disease * Uncontrolled Seizure disorder * Uncontrolled hypertension * Stage IV cancer

Study locations

2 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

Maryland, United States: 2

Sample of listed locations

Cynthia Renn — Baltimore, Maryland, 21201, United States — Site recruitment status not specified in the registry data
Morgan State University — Baltimore, Maryland, 21251, United States — Site recruitment status not specified in the registry data

Study details

Start date: March 1, 2025
Primary completion date: January 31, 2029
Completion date: June 30, 2029
First posted: July 26, 2024
Collaborators: University of Maryland, Baltimore

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06522685
Registry last updated: February 6, 2025
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT06522685 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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