Neuromodulation of Central Sensory Integration to Improve Postural Control

November 10, 2025 updated by: Brendan McNeish, MD, University of Pittsburgh

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active tDCS, then Sham tDCS
Stimulation (tDCS) will be delivered in visit 2. Sham will be delivered in visit 3.
Device: transcranial 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
Device: Sham 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.
Experimental: Sham tDCS, then Active tDCS
Sham will be delivered in visit 2. Stimulation (tDCS) will be delivered in visit 3.
Device: transcranial 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
Device: Sham 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.
No Intervention: No Intervention
Participants with a history of cancer and cancer free participants who participated in a single visit without tDCS or sham.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trail Making B test
Time Frame: 2 months
To evaluate executive function and processing speed. A higher score is better cognitive function.
2 months
Digit Symbol Substitution Test
Time Frame: 2 months
Test to evaluate executive function and processing speed. A higher score is better cognitive function.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Brendan McNeish, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Actual)

June 17, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

November 12, 2025

Last Update Submitted That Met QC Criteria

November 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY24020169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The University of Pittsburgh will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, and physiologic data, from all participants.

All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.

IPD Sharing Time Frame

The investigators will make the data and associated documentation available once summary data are published or otherwise made available, starting six months after publication.

IPD Sharing Access Criteria

The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: 1) a commitment to using data only for research purposes and not to identify any particular participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed. The availability of data will be advertised over the Internet through websites maintained by University of Pittsburgh.

All investigators wishing to access the data will submit a brief proposal describing their research project, data needs, regulatory approvals, and mechanisms to assure patient confidentiality. Upon affirmative review by the Principal Investigator and co-investigators of this study, a data-sharing agreement will be signed and the requesting investigators will be given a working data file and appropriate documentation.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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