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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Eshaka Eshwar
- Telefonnummer: 734-232-5901
- E-Mail: eshaka@med.umich.edu
Studienorte
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48109
- University of Michigan Rogel Cancer Center
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Hauptermittler:
- Brendan L. McNeish
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Dual task gait speed cost
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Dual task cost to gait speed
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Brendan L McNeish, University of Michigan Rogel Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UMCC 2026.040
- NCI-2026-05186 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- HUM00288401 (Andere Kennung: University of Michigan Rogel Cancer Center)
- K23AG090624 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
IPD will be available 12/30/2029
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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