Neuromodulation of Central Sensory Integration to Improve Postural Control

Trial Title: Neuromodulation of Central Sensory Integration to Improve Postural Control

NCT ID: NCT06610617

Condition: Survivorship
Quality of Life
Cognitive Deficits, Mild

Conditions: Official terms:
Cognition Disorders
Cognitive Dysfunction

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Intervention model description: 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.

Primary purpose: Basic Science

Masking: Triple (Participant, Care Provider, Investigator)

Masking description: 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.

Intervention:

Intervention type: Device
Intervention name: transcranial direct current stimulation (tDCS)
Description: 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
Arm group label: Active tDCS, then Sham tDCS
Arm group label: Sham tDCS, then Active tDCS

Intervention type: Device
Intervention name: Sham tDCS
Description: 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.
Arm group label: Active tDCS, then Sham tDCS
Arm group label: Sham tDCS, then Active tDCS

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

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Inclusion criteria for breast cancer survivors: - Women aged 60-85 years - Breast cancer survivors, stages I-IIIc - 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 second cancer - Own a device with capability to sync the Fitbit Exclusion criteria for cancer survivors: - 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 below 31). - Chronic vertigo - Myocardial infarction within the past six months - History of platin chemotherapy - History of immunotherapy - Any history of brain or spine surgery, known hearing, visual, or vestibular impairment - Active chemotherapy, radiation, or immunotherapy - Contraindications to transcranial direct simulation (tDCS), including reported seizure within the past five years, active use of neuro-active drugs, metal objects anywhere in the body, 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. - Currently taking anti-epileptic medication

Gender: Female

Gender based: Yes

Gender description: female

Minimum age: 60 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Pittsburgh

Address:
City: Pittsburgh
Zip: 15213
Country: United States

Status: Recruiting

Contact:
Last name: Debbie Harrington

Phone: 412-383-1355
Email: debbie.harrington@pitt.edu

Contact backup:
Last name: Brendan McNeish, MD
Email: mcneishbl@upmc.edu

Start date: October 14, 2024

Completion date: December 2026

Lead sponsor:
Agency: University of Pittsburgh
Agency class: Other

Source: University of Pittsburgh

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06610617
https://www.semanticscholar.org/paper/The-Effect-of-Chemotherapy-on-Balance%2C-Gait%2C-and-A-Wechsler-Wood/dbe4e46d46cc2ba3b3049df77273c0a07a455e53