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

NCT06522685 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: HP-00111489
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Over half of cancer patients receiving common chemotherapy treatments experience painful nerve damage called chemotherapy-induced peripheral neuropathy (CIPN). Non-Hispanic Black (NHB) patients are more likely to suffer from this condition and more often need to reduce their chemotherapy doses compared to Non-Hispanic White (NHW) patients. Currently, only one medication, duloxetine, is approved for treating CIPN, but it doesn't work for everyone. A new approach, transcranial direct current stimulation (tDCS), shows promise as a safe and effective treatment. tDCS can be done at home and reduces the need for hospital visits. Research indicates that tDCS can improve pain responses in the brain's pain control network. There are differences in pain sensitivity and brain activity related to pain between NHB and NHW individuals, which may influence the effectiveness of treatments. This research aims to conduct a study to:

1. 1.Test if tDCS is a helpful treatment for painful CIPN.
2. 2.Investigate how CIPN affects brain function in NHB and NHW patients.
3. 3.Examine the role of inflammation in CIPN and its connection to pain severity and brain function.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Chronic Pain; Neuropathy; Neuropathic Pain; Non-invasive brain stimulation; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (6)

• Number of participants able to adhere to the at home remote stimulation protocol

  Number of participants able to adhere to the at home study protocol comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups

  2 weeks

• Number of side effects reported on the transcranial direct current stimulation side effect questionnaire

  Number of side effects reported on the transcranial direct current stimulation side effect questionnaire comparing non-Hispanic blacks to non-Hispanic whites for both active and sham stimulation groups (n=20 per group; 4 groups)

  2 weeks

• Cortical thickness

  Cortical thickness comparison between non-Hispanic blacks and non-Hispanic whites

  10 minutes

• Blood oxygen level dependent (BOLD) response to sharp mechanical stimuli

  Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy

  10 minutes

• Blood oxygen level dependent (BOLD) response to painful heat stimuli

  Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy

  10 minutes

• Blood oxygen level dependent (BOLD) response to cold heat stimuli

  Comparison between non-Hispanic black and non-Hispanic white participants with and without painful chemotherapy induced peripheral neuropathy

  10 minutes

Secondary Outcomes (2)

• Brief pain inventory short form score

  2 weeks

• Brief pain inventory short form score

  At 6 week follow-up

Study Arms (2)

Left motor cortex targeted anodal transcranial direct current stimulation

EXPERIMENTAL

Active left motor cortex targeted anodal transcranial direct current stimulation at 2 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks.

Device: transcranial direct current stimulation Soterix REMOTE 1x1 miniCT

Left motor cortex targeted sham transcranial direct current stimulation

SHAM COMPARATOR

Active left motor cortex targeted anodal transcranial direct current stimulation at 0 milliamperes applied for 20 minutes once daily on Monday through Friday for two consecutive weeks. The sham consists of a ramp up to 2 mA and immediate ramp down to 0 mA at the beginning of the 20 minute period and a ramp up to 2 mA and immediate ramp down to 0 mA at the end of the 20 minute period.

Device: transcranial direct current stimulation Soterix REMOTE 1x1 miniCT

Interventions

transcranial direct current stimulation Soterix REMOTE 1x1 miniCT DEVICE

Soterix Medical REMOTE Neuromodulation is the only system with device, accessories, and software designed for deployed use. Safe transcranial Electrical Stimulation requires advanced systems designed for consistency and control. REMOTE Neuromodulation is the only system designed from the ground up to allow translation of clinical tES, including tDCS protocols, to diverse deployed environments, while maintaining medical standards.

Also known as: tDCS, Soterix REMOTE 1x1 miniCT

Left motor cortex targeted anodal transcranial direct current stimulation; Left motor cortex targeted sham transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Morgan State University: lead
• University of Maryland, Baltimore: collaborator

Study Sites (2)

Cynthia Renn

Baltimore, Maryland, 21201, United States

Location

Morgan State University

Baltimore, Maryland, 21251, United States

Location

MeSH Terms

Conditions

Chronic Pain; Neuralgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Timothy J Meeker, PhD

CONTACT

443-885-4468; timothy.meeker@morgan.edu

Cynthia Renn, PhD

CONTACT

410-706-5736; renn@umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A numerical code will be put into the device by the participant which will determine whether the device is in real or sham mode. The principal investigator, evaluator and al study staff excepting the device company and study statistician will be blinded to this code.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-Blind Sham-controlled Parallel comparing feasibility in non-Hispanic black participants to non-Hispanic white participants (2 arms, 2 groups each arm; total 4 groups with 20 participants in a group.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 26, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Study protocol and statistical analysis plan are planned to be submitted to a per-registration service or journal about December 2024. Clinical study reports and structural and functional MRI will be submitted to data repositories or peer-reviewed data journals and the Enhancing Neuro Imaging Genetics through Meta Analysis (ENIGMA) Chronic Pain Working group by about December 2030.
• Access Criteria: Any de-identified data not published will be available from the study authors upon reasonable request.

Locations

US (2)