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

Summary

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.

Conditions

• Stroke, Ischemic
• Stroke Hemorrhagic

Interventions

DEVICE

Anodal transcranial direct current stimulation (A-tDCS)

Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA

DEVICE

Cathodal transcranial direct current stimulation (C-tDCS)

Cathodal tDCS will be performed for 20 minutes over the unaffected hemisphere with an intensity set to 2 mA

DEVICE

Sham stimulation (sham-tDCS)

placebo stimulation

BEHAVIORAL

Neuromotor training

conventional neuromotor treatment

Sponsors & Collaborators

• San Gerardo Hospital

  collaborator OTHER

• Maggiore Bellaria Hospital, Bologna

  collaborator OTHER

• Azienda Ospedaliero, Universitaria Pisana

  collaborator OTHER

• Fondazione Don Carlo Gnocchi Onlus

  collaborator OTHER

• Azienda Ospedaliera Universitaria Integrata Verona

  collaborator OTHER

• Azienda Unita Sanitaria Locale di Piacenza

  collaborator OTHER

• Azienda Ospedaliero Universitaria di Cagliari

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• I.R.C.C.S. Fondazione Santa Lucia

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• Istituti Clinici Zucchi

  collaborator OTHER

• Ospedali Riuniti di Foggia

  collaborator OTHER

• IRCCS Centro San Giovanni di Dio Fatebenefratelli

  lead OTHER

Principal Investigators

• Carlo Miniussi, PhD · IRCCS Centro San Giovanni di Dio Fatebenefratelli

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-10

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Italy

Study Locations