Chemotherapy-Induced Peripheral NeuropathyNCT07673614
Transcranial Direct Current Stimulation for the Treatment of Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors
A study testing Survey Administration and Transcranial Direct Current Stimulation in people with Chemotherapy-Induced Peripheral Neuropathy and Hematopoietic and Lymphatic System Neoplasm, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Survey Administration and Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Eshaka Eshwar, 734-232-5901, eshaka@med.umich.edu
Brendan L. McNeish
About this study
Official title: 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.
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Sham Intervention, Survey Administration, Transcranial Direct Current Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham InterventionProcedure or surgery
Also called sham (procedure), Sham Comparator
Undergo sham tDCS
Survey AdministrationOther
Ancillary studies
Transcranial Direct Current StimulationDevice
Also called tDCS
Undergo tDCS
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at weeks 2 and 3
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start10 Sep 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brendan L McNeish, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673614
- Sponsor's protocol ID
- UMCC 2025.097
- Other IDs
- NCI-2026-03995, HUM00276508
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No