NCT06838013

Effect of Combining Central and Peripheral Cutaneous Electrical Stimulation on Lower Limb Motor Function in People With Stroke

A Randomized Controlled Trial of Anodal Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation for Improving Lower Limb Function in Stroke Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. It is hypothesize that lower limb motor function can be best improved by combining anodal tDCS with TENS, when compared with sham-tDCS with TENS, anodal tDCS with placebo-TENS, or control training at improving ankle muscle strength, motor control of lower limbs, walking performance, functional mobility and community integration in people with stroke.

Detailed description

The application of transcutaneous electrical nerve stimulation (TENS) over a paretic lower limb could augment the effects of task-oriented exercise therapy on lower limb motor function in people with stroke, possibly through increased excitability of sensorimotor cortex. In transcranial direct current stimulation (tDCS), a weak electrical current is applied through electrodes placed on the scalp to modulate cortical excitability and neural activity in targeted brain regions. Anodal tDCS, specifically, involves positioning the positively charged electrode over the targeted cortical area, which facilitates neuronal depolarization and increases cortical excitability in the underlying brain tissue. The enhanced neural excitability induced by anodal tDCS could promote neuroplasticity and optimize motor learning processes, potentially through the modulation of N-methyl-D-aspartic acid (NMDA) receptor -dependent mechanisms and alterations in GABAergic activity, leading to improved motor function and rehabilitation outcomes in various neurological conditions. The next question concerns whether anodal tDCS could be combined with TENS and whether their synergetic effects could maximise the motor output of paretic limbs in people with stroke.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation (tDCS)	tDCS will be delivered by a constant-current electrical stimulator (DC-stimulator; Eldith, Ilmenau, Germany). Rectangular electrodes covered with a saline-soaked sponge will be used for the anode and cathode. The anode will be placed over the leg area of the motor cortex, on the lesioned side, with the medial border of the electrode placed laterally to Cz on the international electroencephalogram 10-20 system. The cathode will be placed above the contralateral orbit. The stimulation intensity will be set at 2 mA for 30 minutes.
DEVICE	Sham transcranial direct current stimulation (Sham-tDCS)	Sham tDCS will be delivered by a constant-current electrical stimulator (DC-stimulator; Eldith, Ilmenau, Germany). Rectangular electrodes covered with a saline-soaked sponge will be used for the anode and cathode. The anode will be placed over the leg area of the motor cortex, on the lesioned side, with the medial border of the electrode placed laterally to Cz on the international electroencephalogram 10-20 system. The cathode will be placed above the contralateral orbit. The stimulation intensity will The stimulator will only be applied for the first and last 30 seconds.
DEVICE	Bilateral Transcutaneous electrical nerve stimulation (Bi-TENS)	TENS will be delivered to the common peroneal nerve of both intact and paretic leg for 30 minutes using a 120z Dual-Channel TENS Unit (ITO Physiotherapy \& Rehabilittaion, Co, Ltd, Tokyo, Japan). The TENS stimulation will be at 100 Hz, with 0.2 ms square pulses at an intensity of twice the sensory threshold (defined as the minimum intensity at which subject reported feeling a tingling sensation and below the motor threshold as indicated by the absence of muscle twitching.
DEVICE	Placebo transcutaneous electrical nerve stimulation (Placebo-TENS)	Placebo-TENS will be applied to identical-looking TENS devices, with the electrical circuit disconnected inside the devices. Placebo-TENS will be delivered to the common peroneal nerve of both intact and paretic leg for 30 minutes that set at 100 Hz, with 0.2 ms square pulses.
BEHAVIORAL	Lower-limb task-oriented training	The lower-limb task-oriented training comprises 5 exercises for 30 minutes, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, gait re-education and transition training.

Timeline

• Start date: 2024-06-17
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2025-02-20
• Last updated: 2025-07-09

Locations

1 site across 1 country: Hong Kong