NCT06610617

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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. Outcome measure were removed. Remaining outcome measures were ones that were assessed both before and after tDCS.

Conditions

• Survivorship
• Quality of Life
• Cognitive Deficits, Mild

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-06-17
• Completion: 2025-07-31
• First posted: 2024-09-24
• Last updated: 2025-11-12

Locations

1 site across 1 country: United States