Clinical trial · Interventional
Neuromodulation of Central Sensory Integration to Improve Postural Control
Neuromodulation of Central Sensory Integration to Improve Postural Control: A Pilot Study in Older Women With Breast Cancer
NCT06610617CI-TRIAL-00097159completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective is to evaluate if neuromodulation of the PFC can acutely improve sensory integration for balance performance in OTTBCS.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Deficits, Mild | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham tDCS | Device | — | UNRESOLVED |
| transcranial direct current stimulation (tDCS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Active tDCS, then Sham tDCS
- description
- Stimulation (tDCS) will be delivered in visit 2. Sham will be delivered in visit 3.
- interventionNames
- Device: transcranial direct current stimulation (tDCS)
- Device: Sham tDCS
- type
- EXPERIMENTAL
- label
- Sham tDCS, then Active tDCS
- description
- Sham will be delivered in visit 2. Stimulation (tDCS) will be delivered in visit 3.
- interventionNames
- Device: transcranial direct current stimulation (tDCS)
- Device: Sham tDCS
- type
- NO_INTERVENTION
- label
- No Intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDMcNeish 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
- BACKGROUNDSeretny 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
- BACKGROUNDJanelsins 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
- BACKGROUNDKolb 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
- BACKGROUNDWinters-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
- BACKGROUNDWang 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