Clinical trial NCT06079138: Tele-rehabilitation Using TDCS Combined with Exercise in People with Spinal Cord Injury
Official title: Tele-rehabilitation Using Transcranial Direct Current Stimulation Combined with Exercise in People with Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Incomplete Spinal Cord Injury
Keywords: rehabilitation
home-based exercise
tDCS
SCI
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The participants will be divided into 2 groups. Intervention group will receive active tDCS with intensity 2 mA and control group will receive sham tDCS.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Individuals with any level of SCI with age between 18-70 years.
* Onset of injury between 1-30 month.
* Must have electronic devices such as mobile phones or tablets or computers that can connect to the internet.

Exclusion Criteria:

* Receiving other NIBS and alternative medicine e.g. TMS, acupuncture.
* Having unstable cardiopulmonary disease e.g. unstable angina, uncontrolled atrial or ventricular arrythmias.
* Having uncontrolled conditions e.g. uncontrolled hypertension, uncontrolled diabetes.
* Having a history of other neurological diseases e.g. stroke.
* Having contra-indication to use tDCS (30) which are

  1. Having intracranial metal implantation, cochlear implant, or cardiac pacemaker.
  2. Having an open wound or wound infection on the scalp.
  3. Having a history of brain surgery.
  4. Having a history of epilepsy.

Primary outcomes:
measure: Change from baseline: ASIA impairment scale
timeFrame: Baseline, post-intervention day 30, and 1-month after post-intervention
Secondary outcomes:
measure: Change from baseline: the soleus H-reflex
timeFrame: Baseline, post-intervention day 30, and 1-month after post-intervention
measure: Change from baseline: Modified Ashworth scale
timeFrame: Baseline, post-intervention day 30, and 1-month after post-intervention
measure: Change from baseline: Upper limb muscle strength
timeFrame: Baseline, post-intervention day 30, 1-month after post-intervention
measure: Change from baseline: Spinal cord independence measure III (SCIM III)
timeFrame: Baseline, post-intervention day 30, 1-month after post-intervention
measure: Change from baseline: Transfer assessment instrument (TAI)
timeFrame: Baseline, post-intervention day 30, 1-month after post-intervention
measure: Change from baseline: Quality of life measure
timeFrame: Baseline, post-intervention day 30, 1-month after intervention
Other outcomes:
Locations:
city: Salaya
country: Thailand
facility: Mahidol University
state: Nakhon Pathom
Study officials:
References: