Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Keywords
transcranial direct current stimulation, stroke rehabilitation
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.
Interventions
Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA
DEVICECathodal 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
placebo stimulation
BEHAVIORALNeuromotor training
conventional neuromotor treatment
Sponsors
San Gerardo Hospital
Maggiore Bellaria Hospital, Bologna
Azienda Ospedaliero, Universitaria Pisana
Fondazione Don Carlo Gnocchi Onlus
Azienda Ospedaliera Universitaria Integrata Verona
Azienda Unita Sanitaria Locale di Piacenza
Azienda Ospedaliero Universitaria di Cagliari
Ospedale Policlinico San Martino
I.R.C.C.S. Fondazione Santa Lucia
Catholic University of the Sacred Heart
Istituti Clinici Zucchi
Ospedali Riuniti di Foggia
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Both participants and experimenters will be prevented from having knowledge of the assigned stimulation protocol. To do so, the investigator will create a series of numbers paired with real and sham interventions while the outcome assessor will be aware of the patient-number association only.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 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 |
Countries
Italy
Contacts
Primary ContactMaria Concetta Pellicciari, PhD
Outcome results
None listed