NCT06997744

TENS for Limb Function in Stroke: Design and Rationale for a Randomized Trial

Comparative Effects of 2Hz Versus 100Hz Transcutaneous Electrical Nerve Stimulation on Upper Limb Motor Function Post-Stroke: Design and Rationale for a Randomized Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: CHENGNING Song · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study tests whether slow or fast electrical nerve stimulation (TENS) works better to improve arm movement in people recovering from a stroke. Participants will receive TENS on their weak arm three times a week for eight weeks. The results will help find the best TENS setting to support stroke recovery.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Low-frequency(2HZ) TENS	Participants receive transcutaneous electrical nerve stimulation (TENS) at a frequency of 2Hz. The stimulation is delivered using surface electrodes placed on the affected upper limb. Each session lasts 30 minutes and is conducted three times per week for a total of 8 weeks. Intensity is gradually increased from 1 mA to 3 mA during each session.
DEVICE	High-frequency(100HZ) TENS	Participants receive TENS at a frequency of 100Hz using the same electrode placement and schedule as the 2Hz group. Sessions last 30 minutes, three times weekly for 8 weeks, with intensity increasing from 1 mA to 3 mA across the session. This group represents high-frequency stimulation.
DEVICE	Placebo TENS	Participants use a TENS device identical in appearance to the active treatment units. The power light is on, but no electrical stimulation is delivered due to internal circuit disconnection. Sessions follow the same schedule and duration as the active groups.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-09-30
• Completion: 2028-09-30
• First posted: 2025-05-30
• Last updated: 2025-08-28

Locations

1 site across 1 country: China