Clinical trial NCT04910412: Effects of tDCS With Gait Training on Leg Performance in Incomplete Spinal Cord Injury
Official title: Effects of Transcranial Direct Current Stimulation With Gait Training on Lower Limb Performance in Individual With Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Keywords: Transcranial direct current stimulation
Incomplete spinal cord injury
Lower limb performance
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study aim to investigate the effects of anodal transcranial direct current stimulation combined with gait training for 5 consecutive session on gait performance, balance, sit to stand performance and quality of life in persons with incomplete SCI at post intervention, 1-month follow-up and 2-month follow up

Detailed description: The result from the previous studies of Water in 1994 regarding the ambulation status of patients with spinal cord injury (SCI) for a period of 1 year after injury. It was found that 76% of incomplete paraplegia and 46 % of incomplete tetraplegia can recovery their walking ability to become community ambulators. However, the recovery rate gradually decreased and started to hit the plateau level around 9 months post injury or in chronic phase. Therefore, it is a challenge in rehabilitation to restore their functions such as walking which is a primary goal of functional independence.

Activity-based rehabilitation therapy (ABRT) (such as locomotion training) is an intensive intervention that has the potential to promote neurological recovery and enhance walking ability in individual with incomplete SCI. Although, ABRT showed positive results in motor function recovery in incomplete SCI survivors, it may not be able to promote full recovery, especially in chronic patients. Recent studies showed that the combination of training with top-down approach may be an option that could promote motor recovery after SCI.

transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that is currently being used as an add-on treatment in neurorehabilitation. tDCS over the primary motor cortex has been shown to modulate neural activity at both cortical and spinal levels. It also produce an after-effect in modulating neuronal synaptic plasticity and increasing the expression of brain-derived neurotrophic factor (BDNF). Early tDCS studies have shown that increasing stimulation intensity or duration within certain limits enhances tDCS efficacy: while anodal stimulation increases cortical excitability, cathodal stimulation decreases it. The application of tDCS is to place the electrode in a specific montage on the decided target brain area and deliver the low-intensity current pass through that brain area for neural modulation during or after providing a rehabilitation program. Previous studies of the application of tDCS showed that applying of tDCS on primary motor cortex with intensity of 2 milliampere (mA) for 10-20 minutes combined with rehabilitation can enhance lower limb performance such as knee strength, ankle movement, and sit to stand performance in people with stroke as well as walking speed in people with Parkinson's disease. According to result from those previous studies can revealed that the combination of rehabilitation with modulation of corticospinal excitability can enhance lower limb performance in individual with neurological condition. In individuals with incomplete SCI, the excitability of the preserved corticospinal pathways is reduced which can affect the control of their motor skills and motor recovery. Several studies reported positive effect of anodal tDCS combined with training in individuals with incomplete SCI, however most of studies focused on upper limb function. Only few studies on the outcome of lower limb function and walking ability, which are required to return to their daily living and thus increase in quality of life (QOL). Moreover, most of studies in the lower limb were conducted in a small sample size and reported inconclusive results.

Therefore, the purpose of this study is to determine whether the effects of combining anodal tDCS with gait training for 5 consecutive session in people with incomplete SCI can improve lower limb performance consist of gait performance(spatiotemporal), dynamic balance(time up and go test), sit to stand performance (5 times of sit to stand test) and QOL after a prolonged period of follow-up at 1-month and 2-month compare to control group of sham tDCS with gait training.

Eligibility criteria: Inclusion Criteria:

* American Spinal Injury Association (ASIA) impairment scale C or D
* Age between 18-70 years
* Onset of injury between 1-30 months
* Ability to walk at least 15 meters with or without walking aid

Exclusion Criteria:

* Using other orthoses except the ankle-foot orthosis (AFO)
* Having musculoskeletal pain limiting their walking (pain score \> 5/ 10)
* Modified Ashworth Scale (MAS) greater than 2
* Having unstable cardiopulmonary disease
* 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 which are
* The presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
* Having an open wound or wound infection on the scalp
* Having a history of brain surgery
* Having a history of seizure

Primary outcomes:
measure: Change from baseline in gait efficacy assessed by walking speed(m/s) at 5 days
timeFrame: Baseline and 5 days
measure: Change from baseline in gait efficacy assessed by walking speed(m/s) at 1 month
timeFrame: Baseline and 1 month
measure: Change from baseline in gait efficacy assessed by walking speed (m/s) at 2 months
timeFrame: Baseline and 2 months
Secondary outcomes:
measure: Change from baseline in gait efficacy assessed by stride parameter (m) at 5 days
timeFrame: Baseline and 5 days
measure: Change from baseline in gait efficacy assessed by stride parameter (m) at 1 month
timeFrame: Baseline and 1 month
measure: Change from baseline in gait efficacy assessed by stride parameter (m) at 2 months
timeFrame: Baseline and 2 months
measure: Change from baseline in gait efficacy assessed by cadence (step/min) at 5 days
timeFrame: Baseline and 5 days
measure: Change from baseline in gait efficacy assessed by cadence (step/min) at 1 month
timeFrame: Baseline and 1 month
measure: Change from baseline in gait efficacy assessed by cadence (step/min) at 2 months
timeFrame: Baseline and 2 months
measure: Change from baseline in balance efficacy assessed by duration of timed up and go test at 5 days
timeFrame: Baseline and 5 days
measure: Change from baseline in balance efficacy assessed by duration of timed up and go test (s) at 1 month
timeFrame: Baseline and 1 month
measure: Change from baseline in balance efficacy assessed by duration of timed up and go test (s) at 2 months
timeFrame: Baseline and 2 months
measure: Change from baseline in balance efficacy assessed by duration of five time sit to stand test (s) at 5 days
timeFrame: Baseline and 5 days
measure: Change from baseline in balance efficacy assessed by duration of five time sit to stand test(s) at 1 month
timeFrame: Baseline and 1 month
measure: Change from baseline in balance efficacy assessed by duration of five time sit to stand test (s) at 2 months
timeFrame: Baseline and 2 months
measure: Change from baseline in quality of life assessed by WHOQOL-Bref Thai version (score 26-130) at 1 month
timeFrame: Baseline and 1 month
measure: Change from baseline in quality of life assessed by WHOQOL-Bref Thai version (score 26-130) at 2 months
timeFrame: Baseline and 2 month
Other outcomes:
Locations:
city: Nonthaburi
country: Thailand
facility: Sirindhorn National Medical Rehabilitation Institute
Study officials:
affiliation: Mahidol University
name: Wanalee Klomjai, PhD
role: STUDY_DIRECTOR
References: