Status:
COMPLETED
Neuromodulation of Central Sensory Integration to Improve Postural Control
Lead Sponsor:
University of Pittsburgh
Conditions:
Survivorship
Quality of Life
Eligibility:
FEMALE
50-85 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06610617
Start Date
October 14 2024
End Date
July 31 2025
Last Update
November 12 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213