Cognitive Deficits, Mild, Quality of Life, Survivorship
Conditions
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. Outcome measure were removed. Remaining outcome measures were ones that were assessed both before and after tDCS.
Interventions
DEVICEtranscranial direct current stimulation (tDCS)
tDCS designed to facilitate the excitability of the left dlPFC or sham stimulation on separate visits separated by at least one week in random order, using a double-blinded, within-subject crossover design. Electrode placement and current parameters will be optimized to each participant with the goal of generating an average electric field of 0.25 V/m within the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA using the Stimweaver algorithm. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort
DEVICESham tDCS
Active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention delivers currents and mimics the sensations induced by tDCS, but does not significantly influence cortical tissue.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Those who receive tDCS on Visit 1 will receive sham stimulation on Visit 2, and those who receive sham on Visit 21and will receive tDCS stimulation on Visit 2. The order of tDCS and sham stimulation is randomized so half of the participants will receive active tDCS first and half will receive tDCS sham. The study member will also be blinded to delivering active or sham tDCS to the participant.
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. On 4/2/25, after enrollment of the first 4 cancer survivor participants in the randomized trial, the design was modified to allow cancer survivor participants to opt in or out of the tDCS intervention to compare to the cancer free group.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
for breast, ovarian and endometrial cancer survivors: * Women aged 50-85 years * Breast, ovarian and/or endometrial cancer survivors, stages I-IV * 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 other cancer, with the exception that non-melanoma skin cancers are permitted * Own a device with capability to sync the Fitbit Inclusion criteria for older cancer-free women: * Women aged 50-85 years * Ability to walk without an assistive device * Ability to speak and read English * Without neurological disease * No history of cancer * Own a device with capability to sync the Fitbit Inclusion for older, taxane-treated breast, ovarian, and endometrial cancer survivors (OTTBCS) performing a single visit: * Women aged 50-85 years * Breast, ovarian and/or endometrial cancer survivors, stages I-IV * 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 other cancer, with the exception that non-melanoma skin cancers are permitted * Own a device with capability to sync the Fitbit
Exclusion criteria
for cancer survivors and older women: * 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\<31) * Chronic vertigo * Myocardial infarction within the past six months * Any history of brain or spine surgery, known hearing, visual, or vestibular impairment * Active chemotherapy, radiation (see below) * Currently taking anti-epileptic medication * Known Brain Metastasis Exclusion for older, taxane-treated breast, ovarian, and endometrial cancer survivors (OTTBCS) performing a single visit: * 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\<31) * Chronic vertigo * Myocardial infarction within the past six months * Known hearing, visual, or vestibular impairment * Active chemotherapy, radiation (see below) * Known Brain Metastasis Additional Criteria for cancer survivors: * The following criteria is only exclusionary if participant will receive tDCS. Contraindications to transcranial direct simulation (tDCS), including reported seizure within the past 2 years, Currently taking anti-epileptic medication, active use of neuro-active drugs, metal objects anywhere in the head or the neck, 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. Any history of brain or spine surgery * Active chemotherapy after the first line of 6 cycles is completed will be eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equilibrium Score on Sensory Organization Test | 8 months | The primary outcome measure of Aim 2 will be the change in composite equilibrium score from before and immediately after a single exposure of tDCS or sham stimulation. Briefly, equilibrium score is assessment of postural sway, which can range from 0 to 100, where a lower score indicates more sway and a zero indicates a fall. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Trail Making B test | 2 months | To evaluate executive function and processing speed. A higher score is better cognitive function. |
| Digit Symbol Substitution Test | 2 months | Test to evaluate executive function and processing speed. A higher score is better cognitive function. |
Countries
United States
Outcome results
None listed