Clinical trial NCT06610617: Neuromodulation of Central Sensory Integration to Improve Postural Control
Official title: Neuromodulation of Central Sensory Integration to Improve Postural Control: a Pilot Study in Older Women with Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Survivorship
Quality of Life
Cognitive Deficits, Mild
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The interventional study model is a randomized, double-blinded, crossover trial in older taxane treated breast cancer survivors comparing effects of balance between active and sham treatments of a single exposure of transcranial direct current stimulation to the left dorsolateral prefrontal cortex.
Primary purpose: BASIC_SCIENCE

Brief summary: The objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS.

Detailed description: Sensory integration required for balance will be measured using the sensory organization test which includes six conditions in which visual and proprioceptive sensory cues are sequentially referenced (i.e. reduced) to stress available sensory information and sensory integration for postural control. Performance on the sensory organization test has been correlated with falls and successful response to balance perturbation.Balance performance will be evaluated by postural sway. Cognitive function will be assessed using the NIH toolbox with a focus on executive function. tDCS will be used to modify PFC excitability and measure its immediate after-effect on balance performance while performing the sensory organization test in OTTBCS. CIPN severity will be evaluated using measurements of distal proprioception.The study sample will be older breast cancer survivors (n=20) diagnosed and treated with taxane chemotherapy after the age of 60 years to avoid heterogeneity due to multiple cancer types, treatments, and sexes.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for breast cancer survivors:

* Women aged 60-85 years
* Breast cancer survivors, stages I-IIIc
* Completion of taxane chemotherapy treatment. Taxane combined with a history of anthracycline and/or cyclophosphamide is permitted. Active anti-estrogen therapy is permitted. Receiving platin based agents is permitted.
* Ability to walk without an assistive device
* Ability to speak and read English
* Without neurological disease, aside from chemotherapy induced peripheral neuropathy (CIPN) or chemotherapy related cognitive dysfunction (CRCD)
* No history of a second cancer
* Own a device with capability to sync the Fitbit

Exclusion criteria for cancer survivors:

* Inability to stand or walk unassisted for 60 seconds
* 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. Cognitive status assessed via the Telephone Interview of Cognitive Status (mTICS). We will exclude those with marked dementia (score below 31).
* Chronic vertigo
* Myocardial infarction within the past six months
* History of platin chemotherapy
* History of immunotherapy
* Any history of brain or spine surgery, known hearing, visual, or vestibular impairment
* Active chemotherapy, radiation, or immunotherapy
* Contraindications to transcranial direct simulation (tDCS), including reported seizure within the past five years, active use of neuro-active drugs, metal objects anywhere in the body, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp.
* Currently taking anti-epileptic medication

Primary outcomes:
measure: Equilibrium Score on Sensory Organization Test
timeFrame: 8 months
Secondary outcomes:
measure: Dual Task Cost to Balance
timeFrame: 2 months
measure: Trail Making B test
timeFrame: 2 months
measure: Digit Symbol Substitution Test
timeFrame: 2 months
measure: Reaction Accuracy by the reacstick
timeFrame: 2 months
measure: Fluid Compositive (from the NIH toolbox)
timeFrame: 2 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brendan McNeish, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McNeish BL, Richardson JK, Bell SG, Whitney DG. Chemotherapy-induced peripheral neuropathy increases nontraumatic fracture risk in breast cancer survivors. JBMR Plus. 2021 Jun 10;5(8):e10519. doi: 10.1002/jbm4.10519. eCollection 2021 Aug.
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citation: Janelsins MC, Heckler CE, Peppone LJ, Kamen C, Mustian KM, Mohile SG, Magnuson A, Kleckner IR, Guido JJ, Young KL, Conlin AK, Weiselberg LR, Mitchell JW, Ambrosone CA, Ahles TA, Morrow GR. Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. J Clin Oncol. 2017 Feb 10;35(5):506-514. doi: 10.1200/JCO.2016.68.5826. Epub 2016 Dec 28.
citation: Kolb NA, Smith AG, Singleton JR, Beck SL, Stoddard GJ, Brown S, Mooney K. The Association of Chemotherapy-Induced Peripheral Neuropathy Symptoms and the Risk of Falling. JAMA Neurol. 2016 Jul 1;73(7):860-6. doi: 10.1001/jamaneurol.2016.0383.
citation: Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.
citation: Wang AB, Housley SN, Flores AM, Kircher SM, Perreault EJ, Cope TC. A review of movement disorders in chemotherapy-induced neurotoxicity. J Neuroeng Rehabil. 2021 Jan 25;18(1):16. doi: 10.1186/s12984-021-00818-2.
citation: Mirelman A, Herman T, Brozgol M, Dorfman M, Sprecher E, Schweiger A, Giladi N, Hausdorff JM. Executive function and falls in older adults: new findings from a five-year prospective study link fall risk to cognition. PLoS One. 2012;7(6):e40297. doi: 10.1371/journal.pone.0040297. Epub 2012 Jun 29.
citation: Rosano C, Simonsick EM, Harris TB, Kritchevsky SB, Brach J, Visser M, Yaffe K, Newman AB. Association between physical and cognitive function in healthy elderly: the health, aging and body composition study. Neuroepidemiology. 2005;24(1-2):8-14. doi: 10.1159/000081043.
citation: McNeish BL, Dittus K, Mossburg J, Krant N, Steinharter JA, Feb K, Cote H, Hehir MK, Reynolds R, Redfern MS, Rosano C, Richardson JK, Kolb N. Executive function is associated with balance and falls in older cancer survivors treated with chemotherapy: A cross-sectional study. J Geriatr Oncol. 2023 Nov;14(8):101637. doi: 10.1016/j.jgo.2023.101637. Epub 2023 Sep 28.