Clinical trial NCT04166968: Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery
Official title: Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Keywords: transcranial direct current stimulation
stroke rehabilitation
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
Collaborators: name: San Gerardo Hospital
name: Maggiore Bellaria Hospital, Bologna
name: Azienda Ospedaliero, Universitaria Pisana
name: Fondazione Don Carlo Gnocchi Onlus
name: Azienda Ospedaliera Universitaria Integrata Verona
name: Azienda Unita Sanitaria Locale di Piacenza
name: Azienda Ospedaliero Universitaria di Cagliari
name: Ospedale Policlinico San Martino
name: I.R.C.C.S. Fondazione Santa Lucia
name: Catholic University of the Sacred Heart
name: Istituti Clinici Zucchi
name: Ospedali Riuniti di Foggia
First posted: 2019-11-18
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study will be conducted in over 15 recruiting centers with a randomized double-blind design. Post-stroke patients will be randomly assigned to 3 parallel groups: Control Group (neuromotor training and sham stimulation), Experimental Group 1 (neuromotor training and cathodal tDCS over the unaffected hemisphere), Group 2 (neuromotor training and anodal tDCS over the affected hemisphere). Participants will be further partitioned on the basis of the acute/subacute and subacute/chronic stages (7-90 and 91 days from lesion onset, respectively).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline Fugl Meyer Assessment Scale (FMA)
timeFrame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
Secondary outcomes:
measure: Changes from Baseline Box & Block Test (B&B)
timeFrame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
measure: Changes from Baseline Barthel Index (BI)
timeFrame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
measure: Changes from Baseline Trunk Control Test (TCT)
timeFrame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
measure: Changes from Baseline Berg Balance Scale ( BBS)
timeFrame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
measure: Changes from Baseline 10 Meters Walking Test
timeFrame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
measure: Changes from Baseline Functional Ambulatory Classification (FAC)
timeFrame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli
state: Lombardia
Study officials:
affiliation: IRCCS Centro San Giovanni di Dio Fatebenefratelli
name: Carlo Miniussi, PhD
role: PRINCIPAL_INVESTIGATOR
References: