Transcranial Direct Current Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors

Improving Sensorimotor Function in CIPN: A Randomized, Sham Controlled, Double Blinded, Crossover Mechanistic Trial of Transcranial Direct Current to the Sensorimotor Cortex

This clinical trial tests how well a type of non-invasive brain stimulation called transcranial direct current stimulation (tDCS) works to treat chemotherapy induced peripheral neuropathy (CIPN) in cancer survivors. CIPN is numbness, tingling, pain, and movement problems that can develop after chemotherapy as a result of changes to the nerves. A non-invasive form of brain stimulation called tDCS, applied to the area of the brain involved in sensation and movement, can temporarily improve the ability to detect vibration and temperature, as well as balance and walking, which may improve sensation and reduce pain in cancer survivors with CIPN.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm; Chemotherapy-Induced Peripheral Neuropathy; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Device: Transcranial Direct Current Stimulation; Procedure: Sham Intervention

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eshaka Eshwar; Phone Number: 734-232-5901; Email: eshaka@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center
      • Principal Investigator: Brendan L. McNeish
      • Contact: Eshaka Eshwar; Phone Number: 734-232-5901; Email: eshaka@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 to 85 years of age
• Diagnosis of cancer, stages I-IV
• Cancer survivor (not currently receiving chemotherapy, radiation, or immunotherapy)
• Presence of CIPN defined as new, length-dependent numbness, tingling, and/or pain that developed with neurotoxic chemotherapy
• CIPN20 score ≥ 20
• Able to walk unassisted
• Proficient in English

Exclusion Criteria:

• Known brain metastases
• Known neurological conditions aside from chemotherapy-induced peripheral neuropathy (CIPN)
• History of brain or spinal surgery
• Neuropathy other than CIPN
• Significant hearing or vision deficits
• Vestibulopathy
• Currently receiving chemotherapy, radiation therapy, or immunotherapy
• Contraindications to transcranial direct current stimulation (tDCS), including recent seizures
• Presence of metallic objects in the head
• Presence of specific implanted medical devices (e.g., deep brain stimulator, cochlear implant, vagus nerve stimulator, spinal cord stimulator, pacemakers, and intracardiac devices)
• Active scalp dermatological conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (active tDCS); Patients undergo tDCS to the sensorimotor cortex, using the Starstim-8™ system, for 20 minutes. One week later, patients cross-over to Arm II.	Other: Survey Administration; Ancillary studies; Device: Transcranial Direct Current Stimulation; Undergo tDCS; Other Names: tDCS
Sham Comparator: Arm II (sham tDCS); Patients undergo sham tDCS to the sensorimotor cortex, using the Starstim-8™ system, for 20 minutes. One week later, patients cross-over to Arm I.	Other: Survey Administration; Ancillary studies; Procedure: Sham Intervention; Undergo sham tDCS; Other Names: Sham Comparator; sham (procedure)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vibration detection threshold	Assessed via Vibration Detection Threshold (CASE IV): Quantitative sensory testing (QTS) for large fiber function. Will conduct a series of two-way analysis of variance (ANOVAs) with each of the vibratory thresholds, cold thresholds, and physical function measures as the dependent variables. Group (active transcranial direct current stimulation [tDCS] versus sham tDCS) and time (baseline, immediate post) will be included as fixed factors of interest along with their interaction to assess treatment effects over time.	at weeks 2 and 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cold detection threshold	Assessed via Cold Detection Threshold (CASE IV): QST for small fiber function. Will conduct a series of two-way ANOVAs with each of the vibratory thresholds, cold thresholds, and physical function measures as the dependent variables. Group (active tDCS versus sham tDCS) and time (baseline, immediate post) will be included as fixed factors of interest along with their interaction to assess treatment effects over time.	at weeks 2 and 3
Correlation between executive function and chemotherapy-induced peripheral neuropathy (CIPN) severity	Assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN20. Will use multivariable models with CIPN20 as the dependent variable, executive function as the primary predictor, and sural amplitude as a covariate. Additional covariates will include age, sex, depression, and pain.	At baseline

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Brendan L McNeish, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 24, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; salicylhydroxamic acid; Transcranial Direct Current Stimulation
• Other Study ID Numbers: UMCC 2025.097; NCI-2026-03995 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); HUM00276508 (Other Identifier: University of Michigan Rogel Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No