NCT04515121

High-definition Transcranial Electrical Stimulation for Lower Limb Stroke Rehabilitation

Effects of High-definition Transcranial Electrical Stimulation on the Lower Extremity in Patients With Stroke

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Taipei Medical University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However, the existing tCES products effect on the whole brain networks and lack special waveforms. We developed a wearable high-definition tCES (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, we will preliminarily examine the effects and safety of the HD-tCES on lower extremity in patients with stroke. We expect that the HD-tCES combined with the lower extremity rehabilitation can shorten the duration of rehabilitative periods, improve stroke patients' activity of daily living, reduce the care burden of patients' family, and subsequently decrease the cost of health care insurance.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	HD-tCES	The high definition transcranial electrical stimulation was applied using a 1\*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). HD-tCES will be applied for 20 minutes at an intensity of 1.0 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 4 weeks.
DEVICE	Sham HD-tCES	The high definition transcranial electrical stimulation was applied using a 1\*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). Sham HD-tCES will consist of a 5-second ramp up to 1.0 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
OTHER	Lower limb rehabilitation	Lower limb rehabilitation programs will be selected and graded in accordance with each patient's lower limb function and specific aims of activities of daily living. Lower limb rehabilitation will be provided for 30 minutes each time, 3 times a week, lasting for 4 weeks.

Timeline

• Start date: 2020-08-20
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2020-08-17
• Last updated: 2023-01-31

Locations

3 sites across 1 country: Taiwan