Neuromodulation of Central Sensory Integration to Improve Postural Control

NCT06610617 | Completed

• 1 other identifier: STUDY24020169
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Survivorship; Quality of Life; Cognitive Deficits, Mild

Outcome Measures

Primary Outcomes (1)

• Equilibrium Score on Sensory Organization Test

  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 Outcomes (2)

• Trail Making B test

  2 months

• Digit Symbol Substitution Test

  2 months

Study Arms (3)

Active tDCS, then Sham tDCS

EXPERIMENTAL

Stimulation (tDCS) will be delivered in visit 2. Sham will be delivered in visit 3.

Device: transcranial direct current stimulation (tDCS); Device: Sham tDCS

Sham tDCS, then Active tDCS

EXPERIMENTAL

Sham will be delivered in visit 2. Stimulation (tDCS) will be delivered in visit 3.

Device: transcranial direct current stimulation (tDCS); Device: Sham tDCS

No Intervention

NO INTERVENTION

Participants with a history of cancer and cancer free participants who participated in a single visit without tDCS or sham.

Interventions

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

Active tDCS, then Sham tDCS; Sham tDCS, then Active tDCS

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.

Active tDCS, then Sham tDCS; Sham tDCS, then Active tDCS

Eligibility Criteria

• Age: 50 Years - 85 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Women aged 50-85 years

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (9)

• McNeish BL, Richardson JK, Bell SG, Whitney DG. Chemotherapy-induced peripheral neuropathy increases nontraumatic fracture risk in breast cancer survivors. JBMR Plus. 2021 Jun 10;5(8):e10519. doi: 10.1002/jbm4.10519. eCollection 2021 Aug.

  PMID: 34368609 BACKGROUND

• Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.

  PMID: 25261162 BACKGROUND

• Janelsins MC, Heckler CE, Peppone LJ, Kamen C, Mustian KM, Mohile SG, Magnuson A, Kleckner IR, Guido JJ, Young KL, Conlin AK, Weiselberg LR, Mitchell JW, Ambrosone CA, Ahles TA, Morrow GR. Cognitive Complaints in Survivors of Breast Cancer After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, Multicenter, Prospective Longitudinal Study. J Clin Oncol. 2017 Feb 10;35(5):506-514. doi: 10.1200/JCO.2016.68.5826. Epub 2016 Dec 28.

  PMID: 28029304 BACKGROUND

• Kolb NA, Smith AG, Singleton JR, Beck SL, Stoddard GJ, Brown S, Mooney K. The Association of Chemotherapy-Induced Peripheral Neuropathy Symptoms and the Risk of Falling. JAMA Neurol. 2016 Jul 1;73(7):860-6. doi: 10.1001/jamaneurol.2016.0383.

  PMID: 27183099 BACKGROUND

• Winters-Stone KM, Horak F, Jacobs PG, Trubowitz P, Dieckmann NF, Stoyles S, Faithfull S. Falls, Functioning, and Disability Among Women With Persistent Symptoms of Chemotherapy-Induced Peripheral Neuropathy. J Clin Oncol. 2017 Aug 10;35(23):2604-2612. doi: 10.1200/JCO.2016.71.3552. Epub 2017 Jun 6.

  PMID: 28586243 BACKGROUND

• Wang AB, Housley SN, Flores AM, Kircher SM, Perreault EJ, Cope TC. A review of movement disorders in chemotherapy-induced neurotoxicity. J Neuroeng Rehabil. 2021 Jan 25;18(1):16. doi: 10.1186/s12984-021-00818-2.

  PMID: 33494755 BACKGROUND

• Mirelman A, Herman T, Brozgol M, Dorfman M, Sprecher E, Schweiger A, Giladi N, Hausdorff JM. Executive function and falls in older adults: new findings from a five-year prospective study link fall risk to cognition. PLoS One. 2012;7(6):e40297. doi: 10.1371/journal.pone.0040297. Epub 2012 Jun 29.

  PMID: 22768271 BACKGROUND

• Rosano C, Simonsick EM, Harris TB, Kritchevsky SB, Brach J, Visser M, Yaffe K, Newman AB. Association between physical and cognitive function in healthy elderly: the health, aging and body composition study. Neuroepidemiology. 2005;24(1-2):8-14. doi: 10.1159/000081043.

  PMID: 15459503 BACKGROUND

• McNeish BL, Dittus K, Mossburg J, Krant N, Steinharter JA, Feb K, Cote H, Hehir MK, Reynolds R, Redfern MS, Rosano C, Richardson JK, Kolb N. Executive function is associated with balance and falls in older cancer survivors treated with chemotherapy: A cross-sectional study. J Geriatr Oncol. 2023 Nov;14(8):101637. doi: 10.1016/j.jgo.2023.101637. Epub 2023 Sep 28.

  PMID: 37776612 BACKGROUND

Related Links

• The Effect of Chemotherapy on Balance, Gait, and Falls Among Cancer Survivors: A Scoping Review

MeSH Terms

Conditions

Cognition Disorders; Lymphoma, Follicular

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Brendan McNeish, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 24, 2024
• Study Start: October 14, 2024
• Primary Completion: June 17, 2025
• Study Completion: July 31, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)