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

6. november 2026 oppdatert av: University of Michigan Rogel Cancer Center

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Rogel Cancer Center
        • Hovedetterforsker:
          • Brendan L. McNeish

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm I: tDCS first, followed by sham

Patients receive tDCS, over 20 minutes. One week later patients crossover to receive sham
Annen: Survey Administration

Ancillary studies

Fremgangsmåte: Sham Intervention

Receive sham tDCS

Andre navn:
  • Sham-komparator
  • sham (procedure)
Enhet: Transcranial Direct Current Stimulation

Receive tDCS

Andre navn:
  • tDCS
Eksperimentell: 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
Annen: Survey Administration

Ancillary studies

Fremgangsmåte: Sham Intervention

Receive sham tDCS

Andre navn:
  • Sham-komparator
  • sham (procedure)
Enhet: Transcranial Direct Current Stimulation

Receive tDCS

Andre navn:
  • tDCS

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dual task gait speed cost
Tidsramme: Before and after stimulation at visit 2 and 3

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Dual task cost to gait speed
Tidsramme: At baseline

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
Prefrontal hemodynamic response
Tidsramme: At baseline

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Michigan Rogel Cancer Center

Samarbeidspartnere

National Institute on Aging (NIA)

Etterforskere

  • Hovedetterforsker: Brendan L McNeish, University of Michigan Rogel Cancer Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. desember 2026

Primær fullføring (Antatt)

1. desember 2029

Studiet fullført (Antatt)

1. desember 2029

Datoer for studieregistrering

Først innsendt

2. oktober 2026

Først innsendt som oppfylte QC-kriteriene

2. oktober 2026

Først lagt ut (Faktiske)

8. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • UMCC 2026.040
  • NCI-2026-05186 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • HUM00288401 (Annen identifikator: University of Michigan Rogel Cancer Center)
  • K23AG090624 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

IPD will be available 12/30/2029

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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