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

Not Applicable

• Conditions: Stroke, Ischemic; Stroke Hemorrhagic
• Interventions: Device: Cathodal transcranial direct current stimulation (C-tDCS); Device: Anodal transcranial direct current stimulation (A-tDCS); Device: Sham stimulation (sham-tDCS); Behavioral: Neuromotor training

• Registration Number: NCT04166968
• Lead Sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-10
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-15
• Study First Posted: 2019-11-18
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Neuromotor training	neuromotor training and anodal stimulation over the affected hemisphere
Control Group	Neuromotor training	neuromotor training and placebo stimulation
Group 1	Cathodal transcranial direct current stimulation (C-tDCS)	neuromotor training and cathodal stimulation over the unaffected hemisphere
Group 2	Anodal transcranial direct current stimulation (A-tDCS)	neuromotor training and anodal stimulation over the affected hemisphere
Group 1	Neuromotor training	neuromotor training and cathodal stimulation over the unaffected hemisphere
Control Group	Sham stimulation (sham-tDCS)	neuromotor training and placebo stimulation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Centro San Giovanni di Dio Fatebenefratelli; 🇮🇹 Brescia, Lombardia, Italy