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The objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS, then Sham tDCS | Experimental | Stimulation (tDCS) will be delivered in visit 2. Sham will be delivered in visit 3. |
|
| Sham tDCS, then Active tDCS | Experimental | Sham will be delivered in visit 2. Stimulation (tDCS) will be delivered in visit 3. |
|
| No Intervention | No Intervention | Participants with a history of cancer and cancer free participants who participated in a single visit without tDCS or sham. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Trail Making B test | To evaluate executive function and processing speed. A higher score is better cognitive function. | 2 months |
| Digit Symbol Substitution Test | Test to evaluate executive function and processing speed. A higher score is better cognitive function. |
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Inclusion criteria for breast, ovarian and endometrial cancer survivors:
Inclusion criteria for older cancer-free women:
Inclusion for older, taxane-treated breast, ovarian, and endometrial cancer survivors (OTTBCS) performing a single visit:
Exclusion criteria for cancer survivors and older women:
Exclusion for older, taxane-treated breast, ovarian, and endometrial cancer survivors (OTTBCS) performing a single visit:
Additional Criteria for cancer survivors:
female
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| Name | Affiliation | Role |
|---|---|---|
| Brendan McNeish, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34368609 | Background | 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. | |
| 25261162 | 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. |
| Label | URL |
|---|---|
| The Effect of Chemotherapy on Balance, Gait, and Falls Among Cancer Survivors: A Scoping Review | View source |
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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.
The investigators will make the data and associated documentation available once summary data are published or otherwise made available, starting six months after publication.
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.
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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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.
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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.
|
| 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. |
|
| 2 months |
| 28029304 | 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. |
| 27183099 | 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. |
| 28586243 | 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. |
| 33494755 | 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. |
| 22768271 | 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. |
| 15459503 | 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. |
| 37776612 | 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. |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |