Anatomic Stage I Breast Cancer AJCC v8NCT07864792
Transcranial Direct Current Stimulation to Improve Gait for Breast Cancer Survivor's Who Received Taxene and/or Platinum Chemotherapy
A study testing Survey Administration and Transcranial Direct Current Stimulation in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years, women only
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2029
- 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 60 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
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
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Brendan L. McNeish
About this study
Official title: A Randomized, Sham Controlled, Double Blinded, Crossover Mechanistic Trial of the Impact of Transcranial Direct Current to the Left Dorsolateral Prefrontal Cortex on Gait in Older Breast Cancer Survivor's Post-Taxane Chemotherapy
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.
- Conditions
- 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
- 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
Receive sham tDCS
Survey AdministrationOther
Ancillary studies
Transcranial Direct Current StimulationDevice
Also called tDCS
Receive tDCS
| Study group | Role | What they receive |
|---|---|---|
| Arm I: tDCS first, followed by sham | Experimental | Patients receive tDCS, over 20 minutes. One week later patients crossover to receive sham Receives: Procedure: Sham Intervention; Other: Survey Administration; Device: Transcranial Direct Current Stimulation |
| Arm II (sham tDCS followed by tDCS) | Experimental | Patients receive sham tDCS, over 20 minutes. One week later patients crossover to receive treatment with actual tDCS Receives: Procedure: Sham Intervention; Other: Survey Administration; Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after stimulation at visit 2 and 3
Secondary outcomes (2)
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.
Measured: At baseline
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.
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 posted8 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies 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
- Model description
- Patients are randomized to 1 of 2 arms. After completing the intervention from their original arm they cross over to the remaining arm.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Brendan L McNeish, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864792
- Sponsor's protocol ID
- UMCC 2026.040
- Other IDs
- NCI-2026-05186, HUM00288401, K23AG090624
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.