CClinicalTrials.gg
Not yet recruitingNCT07864792Updated Oct 8, 2026

Transcranial Direct Current Stimulation to Improve Gait for Breast Cancer Survivor's Who Received Taxene and/or Platinum Chemotherapy

An interventional study of Sham Intervention and Survey Administration in Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage III Breast Cancer AJCC v8, sponsored by University of Michigan Rogel Cancer Center. Not yet recruiting at 1 site in United States. Open to female participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by University of Michigan Rogel Cancer Center · Not applicable, Interventional, and Supportive care

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
Female
01

Study summary

This clinical trial tests the effect of transcranial direct current stimulation (tDCS) to improve gait in older breast cancer survivors who received taxane and/or platinum chemotherapy. Chemotherapy, especially taxane or platinum therapy, can cause damage to the to the nerves resulting in numbness, tingling and pain, which can cause difficulty walking. It can also cause cognitive dysfunction which may effect gait. TDCS is a non-invasive brain stimulation device which uses a very mild electrical current applied to the scalp to temporarily stimulate a specific area of the brain involved in thinking and movement which may improve walking, particularly while doing two things at once. TDCS may be effective in improving gait for older breast cancer survivors who received taxane and/or platinum chemotherapy.

02

Conditions studied

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
03

In context

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 317 studies on the registry; 47 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women aged 60-85 years
  • Breast cancer survivors, stages I-IV without clinical suspicion or evidence of brain metastasis
  • Completion of last taxane and/or platinum chemotherapy treatment ≥ 6 months prior, but chemotherapy was received after the age of 60. Taxane combined with a history of platinum, anthracycline and/or cyclophosphamide is permitted. Active anti-estrogen therapy, Anti-HER2, and CDK 4/6 inhibitors are permitted
  • Ability to walk unassisted for 60 seconds
  • Proficient in English
  • Without neurological disease, aside from chemotherapy induced peripheral neuropathy (CIPN) or chemotherapy related cognitive dysfunction (CRCD)
  • No history of a second cancer besides skin cancer

Exclusion criteria

Exclusion Criteria:

  • Hospitalization within the past three months due to acute illness or as the result of a musculoskeletal injury significantly affecting gait or balance
  • Any unstable medical condition
  • Diagnosis of a gait disorder, Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, previous stroke or other neurodegenerative disorder
  • Chronic vertigo
  • Myocardial infarction within the past six months
  • History of immune check point inhibitor therapy
  • Any history of brain or cervical spine surgery, known hearing, visual, or vestibular impairment
  • Active neurotoxic chemotherapy (taxane, platinum or vinca alkaloid) or radiation therapy
  • Contraindications to transcranial direct simulation (tDCS), including reported seizure within the past two years,, metal objects in head or neck, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, cochlear implant, vagus nerve stimulator, spinal cord stimulator, pacemakers, and intracardiac devices, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Arm I: tDCS first, followed by sham

    Patients receive tDCS, over 20 minutes. One week later patients crossover to receive sham

    Procedure: Sham Intervention · Other: Survey Administration · Device: Transcranial Direct Current Stimulation

  • Experimental
    Arm II (sham tDCS followed by tDCS)

    Patients receive sham tDCS, over 20 minutes. One week later patients crossover to receive treatment with actual tDCS

    Procedure: Sham Intervention · Other: Survey Administration · Device: Transcranial Direct Current Stimulation

Interventions

  • ProcedureSham Intervention

    Receive sham tDCS

    Also known as: sham (procedure), Sham Comparator

  • OtherSurvey Administration

    Ancillary studies

  • DeviceTranscranial Direct Current Stimulation

    Receive tDCS

    Also known as: tDCS

06

What researchers measure

Primary outcomes

  1. Dual task gait speed cost

    This cost will be operationalized as the absolute and percent change in gait metrics (time to walk/variability) during dual-task walking relative to walking without a secondary task. Cost will be defined as (\[speed dual task - speed single task\]/speed single task\] \*100). Will fit a series of linear mixed models with each of the dual task costs, prefrontal cortex activation, and executive function measures as the dependent variables; sequence, period, and treatment as fixed effects of interest; baseline values as fixed effect covariates; and a participant-within sequence random effect.

    Time frame: Before and after stimulation at visit 2 and 3

Secondary outcomes

  1. Dual task cost to gait speed

    Will fit a series of analyses of covariance models with each gait single task and dual-task cost measure as the dependent variable; group (older, taxane-treated female breast cancer survivors versus non-cancer historical control group) as the factor of interest; and other measures of interest (age, proprioception, grip strength, depression, and pain) or other variables different between groups as covariates.

    Time frame: At baseline

  2. Prefrontal hemodynamic response

    Assessed via functional near-infrared spectroscopy during dual task gait speed. Will fit a series of linear mixed models with each measure of prefrontal cortex activation as the dependent variable; group (older, taxane-treated female breast cancer survivors versus non-cancer historical control group), task (single/dual), and their interaction as fixed effects; covariates as additional fixed effects; and a participant random effect.

    Time frame: At baseline

07

Study locations

1 site
  • University of Michigan Rogel Cancer Center
    Ann Arbor, Michigan 48109, United States
    • Brendan L. McNeish · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data from this study will be made available after de-identification. Data will be available after the completion of the study or after publication, whichever is earlier, through the National Institute on Aging data sharing repository, Aging Research Biobank.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07864792
Lead sponsor
University of Michigan Rogel Cancer Center
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Oct 8, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Oct 8, 2026

Study contacts

Eshaka Eshwar
Contact
eshaka@med.umich.edu
734-232-5901
Brendan L McNeish
principal investigator · University of Michigan Rogel Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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