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

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04166968
• Other study ID #: ITSTUDYTDCS-45-2019
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Contact: Maria Concetta Pellicciari, PhD
• Phone: +39 030 3501597
• Email: studioitalianotdcs[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

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
• 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
• Sham stimulation (sham-tDCS)
placebo stimulation

Behavioral:
• Neuromotor training
conventional neuromotor treatment

Locations

Country	Name	City	State
Italy	IRCCS Centro San Giovanni di Dio Fatebenefratelli	Brescia	Lombardia

Sponsors (13)

Lead Sponsor

Collaborator

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Azienda Ospedaliera Universitaria Integrata Verona, Azienda Ospedaliero Universitaria di Cagliari, Azienda Ospedaliero, Universitaria Pisana, Azienda Unità Sanitaria Locale di Piacenza, Catholic University of the Sacred Heart, Fondazione Don Carlo Gnocchi Onlus, I.R.C.C.S. Fondazione Santa Lucia, Istituti Clinici Zucchi, Maggiore Bellaria Hospital, Bologna, Ospedale Policlinico San Martino, Ospedali Riuniti di Foggia, San Gerardo Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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