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
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Eshaka Eshwar
- Telefoonnummer: 734-232-5901
- E-mail: eshaka@med.umich.edu
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48109
- University of Michigan Rogel Cancer Center
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Hoofdonderzoeker:
- Brendan L. McNeish
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Arm I: tDCS first, followed by sham
Patients receive tDCS, over 20 minutes. One week later patients crossover to receive sham |
Ancillary studies Receive sham tDCS
Andere namen:
Receive tDCS
Andere namen:
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Experimenteel: 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 |
Ancillary studies Receive sham tDCS
Andere namen:
Receive tDCS
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Dual task gait speed cost
Tijdsspanne: Before and after stimulation at visit 2 and 3
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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. |
Before and after stimulation at visit 2 and 3
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Dual task cost to gait speed
Tijdsspanne: At baseline
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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. |
At baseline
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Prefrontal hemodynamic response
Tijdsspanne: At baseline
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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. |
At baseline
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Brendan L McNeish, University of Michigan Rogel Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UMCC 2026.040
- NCI-2026-05186 (Register-ID: CTRP (Clinical Trial Reporting Program))
- HUM00288401 (Andere identificatie: University of Michigan Rogel Cancer Center)
- K23AG090624 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
IPD will be available 12/30/2029
IPD-toegangscriteria voor delen
Appropriate parties with appropriate intention for use of the data, starting at the end of 2029, will have access to PHI-free data, via the National Institute on Aging data sharing repository: Aging Research Biobank.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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