Multicenter Study on the Efficacy of Transcranial Direct Current Stimulation (tDCS) in Post-stroke Motor Recovery
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lombardia
-
Brescia, Lombardia, Italy, 25125
- Recruiting
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
-
Contact:
- Carlo Miniussi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Control Group
neuromotor training and placebo stimulation
|
placebo stimulation
conventional neuromotor treatment
|
|
Experimental: Group 1
neuromotor training and cathodal stimulation over the unaffected hemisphere
|
conventional neuromotor treatment
Cathodal tDCS will be performed for 20 minutes over the unaffected hemisphere with an intensity set to 2 mA
|
|
Experimental: Group 2
neuromotor training and anodal stimulation over the affected hemisphere
|
conventional neuromotor treatment
Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from Baseline Fugl Meyer Assessment Scale (FMA)
Time Frame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
Performance-based assessment of sensorimotor impairment
|
End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes from Baseline Box & Block Test (B&B)
Time Frame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
test for manual dexterity of upper extremity function
|
End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
|
Changes from Baseline Barthel Index (BI)
Time Frame: 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
|
End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
|
Changes from Baseline Trunk Control Test (TCT)
Time Frame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
assessment of the deteriorations in trunk control
|
End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
|
Changes from Baseline Berg Balance Scale ( BBS)
Time Frame: 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
|
End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
|
Changes from Baseline 10 Meters Walking Test
Time Frame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
evaluation of functional mobility, gait, and vestibular function
|
End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
|
Changes from Baseline Functional Ambulatory Classification (FAC)
Time Frame: End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
clinically meaningful outcome measure of mobility
|
End of 1st week; End of 2nd week; End of 3rd week; 90 days follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Carlo Miniussi, PhD, IRCCS Centro San Giovanni di Dio Fatebenefratelli
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITSTUDYTDCS-45-2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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