Neuromodulation of Central Sensory Integration to Improve Postural Control
Status
Conditions
Treatments
Details and patient eligibility
About
The objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
48 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Debbie Harrington, CCRP; Lauren Wilcox, CCRP
Data sourced from clinicaltrials.gov
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