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

NCT07673614 | Not Yet Recruiting DMC FDA Device

• 3 other identifiers: UMCC 2025.097NCI-2026-03995HUM00276508
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-Induced Peripheral Neuropathy; Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cold detection threshold

  at weeks 2 and 3

• Correlation between executive function and chemotherapy-induced peripheral neuropathy (CIPN) severity

  At baseline

Study Arms (2)

Arm I (active tDCS)

EXPERIMENTAL

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; Device: Transcranial Direct Current Stimulation

Arm II (sham tDCS)

SHAM COMPARATOR

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.

Procedure: Sham Intervention; Other: Survey Administration

Interventions

Sham Intervention PROCEDURE

Undergo sham tDCS

Also known as: sham (procedure), Sham Comparator

Arm II (sham tDCS)

Survey Administration OTHER

Ancillary studies

Arm I (active tDCS); Arm II (sham tDCS)

Transcranial Direct Current Stimulation DEVICE

Undergo tDCS

Also known as: tDCS

Arm I (active tDCS)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

salicylhydroxamic acid; Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

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

Study Officials

• Brendan L McNeish

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eshaka Eshwar

CONTACT

734-232-5901; eshaka@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will receive an active sham protocol in which low-level currents are circulated across electrodes for the full 20-minute session. This mimics the sensation of active stimulation without significantly affecting cortical excitability. This method will effectively blind participants and study personnel to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)