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Completed

NCT Number: NCT06610617

Neuromodulation of Central Sensory Integration to Improve Postural Control

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

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Key information

Age range

50 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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

Sham tDCS

Device

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.

Primary outcomes

  1. Equilibrium Score on Sensory Organization Test

    Time frame: 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 outcomes

  1. Trail Making B test

    Time frame: 2 months

    To evaluate executive function and processing speed. A higher score is better cognitive function.

  2. Digit Symbol Substitution Test

    Time frame: 2 months

    Test to evaluate executive function and processing speed. A higher score is better cognitive function.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Neuromodulation of Central Sensory Integration to Improve Postural Control: A Pilot Study in Older Women With Breast Cancer

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2024
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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