Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery

Study Overview
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Brief Summary
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Several previous studies have used tDCS as a neuromodulation tool, showing improvements in several diseases (Lefaucheur et al., 2017). Based on these observations, it is believed that the use of tDCS in combination with specific motor training may provide the opportunity to induce behavioral improvements in patients with motor deficits. As shown in previous reports brain stimulation can, in fact, interact with the intrinsic ability of the brain to repair damaged brain functions, increasing the involvement of compensatory functional networks and thus inducing neuroplasticity. If these low-cost, easy-to-use stimulation techniques prove to be useful in improving motor deficits with long-term effects, the current study would open up new and interesting avenues in the field of neurorehabilitation. Given the potential long-lasting effects of tDCS, there is currently a growing interest in the clinical sector with the aim to reduce motor deficits in patients with brain injury. The most widely used protocols in stroke patients include the application of either anodal on the hypsilesional hemisphere or cathodal tDCS on the unaffected hemisphere (contralateral), so as to increase and decrease the excitability of the motor cortex, respectively (Nitsche and Paulus, 2001). The main objective of this study is to evaluate the effectiveness of transcranial direct current stimulation in enhancing the functional recovery of the upper limb of stroke patients after three weeks of neuromotor training and subsequent follow-up. The secondary objective is to evaluate the treatment effects on balance, gait, motor dexterity and disability, besides the functional recovery of the lower limb.

Official Title
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Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery

Conditions
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Stroke, Ischemic, Stroke Hemorrhagic

Intervention / Treatment
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* Device: Anodal transcranial direct current stimulation (A-tDCS)
* Device: Cathodal transcranial direct current stimulation (C-tDCS)
* Device: Sham stimulation (sham-tDCS)
* Behavioral: Neuromotor training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First-ever ischemic stroke Red or white stroke Barthel Index > 90 before lesion onset Exclusion Criteria: Previous inborn neurological disease Previous acquired neurological disease Previous or current major psychiatric illness Epilepsy or anticonvulsant treatment Use of calcium channel blocker drugs Treatments with other technologies (robotics, FES, etc.) Neurolytic treatments with botulinum toxin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The present study will be conducted in over 15 recruiting centers with a randomized double-blind design. Post-stroke patients will be randomly assigned to 3 parallel groups: Control Group (neuromotor training and sham stimulation), Experimental Group 1 (neuromotor training and cathodal tDCS over the unaffected hemisphere), Group 2 (neuromotor training and anodal tDCS over the affected hemisphere). Participants will be further partitioned on the basis of the acute/subacute and subacute/chronic stages (7-90 and 91 days from lesion onset, respectively).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Group<br>neuromotor training and placebo stimulation | Device: Sham stimulation (sham-tDCS)<br>* placebo stimulation<br>Behavioral: Neuromotor training<br>* conventional neuromotor treatment<br>|
| Experimental: Group 1<br>neuromotor training and cathodal stimulation over the unaffected hemisphere | Device: Cathodal transcranial direct current stimulation (C-tDCS)<br>* Cathodal tDCS will be performed for 20 minutes over the unaffected hemisphere with an intensity set to 2 mA<br>Behavioral: Neuromotor training<br>* conventional neuromotor treatment<br>|
| Experimental: Group 2<br>neuromotor training and anodal stimulation over the affected hemisphere | Device: Anodal transcranial direct current stimulation (A-tDCS)<br>* Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA<br>Behavioral: Neuromotor training<br>* conventional neuromotor treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline Fugl Meyer Assessment Scale (FMA) | Performance-based assessment of sensorimotor impairment | End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline Box & Block Test (B&B) | test for manual dexterity of upper extremity function | End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up | 
| Changes from Baseline Barthel Index (BI) | measure of daily living activities in relation to personal care and mobility of the patient | End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up | 
| Changes from Baseline Trunk Control Test (TCT) | assessment of the deteriorations in trunk control | End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up | 
| Changes from Baseline Berg Balance Scale ( BBS) | test of a person's static and dynamic balance abilities | End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up | 
| Changes from Baseline 10 Meters Walking Test | evaluation of functional mobility, gait, and vestibular function | End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up | 
| Changes from Baseline Functional Ambulatory Classification (FAC) | clinically meaningful outcome measure of mobility | End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation, stroke rehabilitation