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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-85
SponsorUniversity of Michigan Rogel Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Sham Intervention

    Procedure/Surgery

    Receive sham tDCS

  • Survey Administration

    Other intervention

    Ancillary studies

  • Transcranial Direct Current Stimulation

    Device

    Receive tDCS

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm I: tDCS first, followed by shamExperimental treatment 3 interventions
Group B: Arm II (sham tDCS followed by tDCS)Experimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

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University of Michigan Rogel Cancer Center

Lead sponsor

National Institute on Aging (NIA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: