Transcranial Direct Current Stimulation to Improve Gait for Breast Cancer Survivor's Who Received Taxene and/or Platinum Chemotherapy
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years to 85 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether gentle brain stimulation called tDCS can help older breast cancer survivors walk better, especially while doing another task. The device sends a very mild electrical current through the scalp. The study is for women ages 60–85 who received taxane or platinum 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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women ages 60–85.
- Survivors of stage I–IV breast cancer, with no signs or suspicion that cancer has spread to the brain.
- Received taxane or platinum chemotherapy after age 60 and finished the last treatment at least 6 months ago.
- Past taxane treatment with platinum, anthracycline, or cyclophosphamide is allowed. Current anti-estrogen, anti-HER2, or CDK 4/6 treatments are allowed.
- Can walk without help for 60 seconds.
- Can use English well.
- No brain or nerve disease, except nerve damage or thinking problems caused by chemotherapy.
- No history of another cancer, except skin cancer.
Who can't join
- Hospital stay in the past 3 months for a sudden illness or a muscle, bone, or joint injury that greatly affects walking or balance.
- Any medical condition that is not stable.
- A diagnosed walking disorder, Parkinson’s, Alzheimer’s, dementia, multiple sclerosis, past stroke, or another disease that damages the brain or nerves over time.
- Long-term vertigo (a spinning feeling), or a heart attack in the past 6 months.
- Past treatment with immune checkpoint inhibitors, a type of cancer treatment.
- Any past brain or neck-spine surgery, or known hearing, vision, or inner-ear balance problems.
- Current chemotherapy that can damage nerves, such as taxane, platinum, or vinca alkaloid drugs, or current radiation treatment.
- Reasons tDCS may be unsafe: a seizure in the past 2 years; metal in the head or neck; certain implanted devices, such as brain, nerve, or spinal cord stimulators, cochlear hearing implants, pacemakers, or devices inside the heart; or an active scalp skin condition, such as eczema.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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: * 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
Study sites (1)
MI
- University of Michigan Rogel Cancer Center · Ann Arbor, MI 48109Brendan L. McNeish · Principal investigatorMore trials in Ann Arbor