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

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Status: Unknown

Conditions: Stroke Hemorrhagic; Stroke, Ischemic

Treatments: Device: Cathodal transcranial direct current stimulation (C-tDCS); Device: Anodal transcranial direct current stimulation (A-tDCS); Device: Sham stimulation (sham-tDCS); Behavioral: Neuromotor training

Study type: Interventional

Funder types: Other

Identifiers

NCT04166968

ITSTUDYTDCS-45-2019

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 3 patient groups

Control Group

Sham Comparator group

Description:

neuromotor training and placebo stimulation

Treatment:

Device: Sham stimulation (sham-tDCS)

Behavioral: Neuromotor training

Group 1

Experimental group

Description:

neuromotor training and cathodal stimulation over the unaffected hemisphere

Treatment:

Device: Cathodal transcranial direct current stimulation (C-tDCS)

Behavioral: Neuromotor training

Group 2

Experimental group

Description:

neuromotor training and anodal stimulation over the affected hemisphere

Treatment:

Device: Anodal transcranial direct current stimulation (A-tDCS)

Behavioral: Neuromotor training