NCT05673720

Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty

Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty

Detailed description

The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	active tDCS paired with active MBM	Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session for 5 times via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session for 5 times by a recorded meditation.
DEVICE	sham tDCS paired with sham MBM	For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.

Timeline

• Start date: 2023-05-15
• Primary completion: 2024-09-25
• Completion: 2024-10-25
• First posted: 2023-01-06
• Last updated: 2025-11-24
• Results posted: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study