NCT06079138

Tele-rehabilitation Using TDCS Combined with Exercise in People with Spinal Cord Injury

Tele-rehabilitation Using Transcranial Direct Current Stimulation Combined with Exercise in People with Spinal Cord Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Months – 70 Months
• Healthy volunteers: Not accepted

Summary

This study aims to explore the effect of trans cranial direct current stimulation (tDCS) combined with self-exercise at home for 1 month training (3 sessions/week, for 4 weeks). The outcome assessment including motor function, functional activity, spasticity through neurological assessment (H reflex latency and H/M amplitude ratio) and quality of life will be assessed before, after the intervention and at 1- month follow-up. Participant will communicate with physical therapist via video online platform for every sessions (12 sessions).

Detailed description

Spinal cord injury (SCI) can cause paralysis and functional disability, resulting in changes in strength and sensation. Rehabilitation is important for regaining independence, but short hospital stays and limited access to specialized clinics pose challenges. Telerehabilitation offers a solution by providing remote rehabilitation services. Physical exercise and functional training are important for improving functional activity and endurance after SCI. Telerehabilitation has shown significant improvements in functional activity. However, the most effective gains occur within the first year after the injury, and rehabilitation training alone may not achieve full recovery. Impairments below the injury level can lead to changes in brain organization. Combining training with a top-down approach may promote motor recovery after SCI. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique used in neurorehabilitation. It can modulate neural activity in the primary motor cortex at both cortical and spinal levels and induce synaptic plasticity. Studies have shown that adjusting the intensity or duration of tDCS can enhance its effectiveness, with anodal stimulation increasing cortical excitability and cathodal stimulation decreasing it. Home-based tDCS is a safe, accessible, and convenient alternative to hospital-based tDCS. Previous research has suggested a positive trend for combining anodal tDCS with rehabilitation training in individuals with incomplete spinal cord injury. Strong arm endurance is crucial for individuals with complete SCI who require independent transfers and wheelchair use. Studies in healthy adults have demonstrated that tDCS combined with exercise can improve upper arm endurance. However, there is currently no research on the effects of tDCS combined with rehabilitation in improving functional skills for individuals with complete SCI, especially when applied through home-based tDCS with telerehabilitation. In the early stages of spinal shock following a severe spinal cord injury (SCI), the H-reflex, a reflex measure of spinal cord excitability, is typically absent or significantly reduced below the injury site. The degree and duration of this reflex suppression indicate the severity of the injury. This loss of reflex activity is thought to result from decreased excitability of motoneurons due to the sudden loss of input from the brain. However, the H-reflex gradually starts to recover after the initial spinal shock phase. In patients with chronic complete spinal cord lesions, an increased H-reflex amplitude in the soleus muscle suggests heightened central synaptic excitability, which may contribute to the development of hyperreflexia after SCI. Recent research has shown that anodal tDCS can decrease the H/M ratio (the ratio of H-reflex to M-response) and H-reflex latency, leading to improved spasticity in patients with neurological conditions. This study aims to investigate the impact of combining tDCS with self-exercise at home over a one-month training period. The training will involve three sessions per week for four weeks. The assessment will include measures of motor function, functional activity, spasticity (evaluated through neurological assessment of H-reflex latency and H/M amplitude ratio), and quality of life. The participants will interact with a physical therapist through a video online platform for each of the 12 sessions. Assessments will be conducted before and after the intervention, as well as at a one-month follow-up.

Conditions

• Spinal Cord Injury
• Incomplete Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation (Active)	Participants will sit comfortably during the stimulation, and the scalp will be cleaned with alcohol beforehand. The Ybrain MINDD STIM current stimulator will be used with saline-soaked sponge-pad electrodes (35 cm2 in size). Electrode placement will follow the 10-20 EEG system, with the active (anodal) electrode (A) positioned at the vertex (Cz) on the more affected side and the reference (cathodal) electrode (C) placed over the supraorbital region on the less affected side. The electrodes will be attached to a cap before application. In the experimental group, participants will receive real tDCS at 2.0 mA for 20 minutes, with a 30-second ramp-up and ramp-down period.
DEVICE	Transcranial direct current stimulation (Sham)	Participants will sit comfortably during the stimulation, and the scalp will be cleaned with alcohol beforehand. The Ybrain MINDD STIM current stimulator will be used with saline-soaked sponge-pad electrodes (35 cm2 in size). Electrode placement will follow the 10-20 EEG system, with the active (anodal) electrode (A) positioned at the vertex (Cz) on the more affected side and the reference (cathodal) electrode (C) placed over the supraorbital region on the less affected side. The electrodes will be attached to a cap before application. The sham group will receive sham tDCS, where the current will only be delivered for the first 30 seconds and automatically stopped, while the electrodes remain in place for 20 minutes.
OTHER	Telerehabilitation exercise	Telerehabilitation exercise will be provided via tele-conference meeting program. The program will consist of 3 parts. First part, there will be a limb exercise program for 20 minutes to prepare the joint range of motion and muscles. Second part, participants will receive functional balance training for 15 minutes to promote their postural balance during changing positions and static positions. Each exercise will perform 10 repetitions for each set and perform 3 sets. After 2-week of intervention, the set will be progressed to 4 sets. Final part, participants will receive 20 minutes of functional training of wheelchair/bed transferring exercise. Each wheelchair and bed transfer exercise will perform 10 repetitions for each completely transfer and perform 3 sets. After 2-week of intervention, the set will be progressed to 4 sets. After finishing all the programs, they will be asked to cool down by doing breathing exercises with torso stretching for 5 minutes.

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-03-30
• Completion: 2024-08-22
• First posted: 2023-10-12
• Last updated: 2024-09-19

Locations

1 site across 1 country: Thailand