NCT04908631

Safety and Feasibility of tDCS to Enhance Auditory Rehabilitation in Cochlear Implant Recipients

Safety and Feasibility of Transcranial Direct Current Stimulation to Enhance Auditory Rehabilitation in Cochlear Implant Recipients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and feasibility of transcranial direct current stimulation (tDCS) in combination with home-based auditory training therapy in cochlear implant (CI) patients. Changes in speech perception performance will also be evaluated.

Detailed description

Participants will complete a 4 week web-based auditory training program while wearing a transcranial direct current stimulation device (tDCS). The customized auditory training program will be completed at home, in 20 - 30 minute sessions at least five times a week for four weeks. A customized learning and practice plan will be provided along with instructions on use of the tDCS device. tDCS is a non-invasive brain stimulation technique that delivers low-intensity current via electrodes on the scalp to modify neuronal excitability in the underlying cortex. The tDCS system has customizable headgear with disposable, snap-in electrodes that are easy to apply at home without assistance. Speech and hearing assessments will be completed prior to the start of auditory training, at the end of the 4 week training session, and again 6 months later.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	Transcranial Direct Stimulation	Brain stimulation using low-intensity current via electrodes on scalp to modify neuronal excitability in the underlying cortex. The tDCS system has customizable head gear with disposable, snap-in electrodes wihich can be applied at home without assistance.
OTHER	Auditory Training Program	Web-based program uses consonant and vowel recognition and understanding sentences/conversations in quiet and in noise using different talkers, and other types of listening exercises.

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2021-06-01
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study