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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
162
Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA
Cathodal tDCS will be performed for 20 minutes over the unaffected hemisphere with an intensity set to 2 mA
placebo stimulation
conventional neuromotor treatment
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, Lombardy, Italy
RECRUITINGChanges from Baseline Fugl Meyer Assessment Scale (FMA)
Performance-based assessment of sensorimotor impairment
Time frame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
Changes from Baseline Box & Block Test (B&B)
test for manual dexterity of upper extremity function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.