Danielle Boasquevisque
São Paulo, 05652-901, Brazil
NCT Number: NCT02455427
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke.
This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
São Paulo, 05652-901, Brazil
The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment.
Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 60 minutes
In sham tDCS, no current will be delivered through the tDCS device.
Time frame: 2 weeks
frequency of adverse events in the active and sham arms
Time frame: 2 weeks and 14 weeks
Improvement post treatment
Time frame: 2 weeks and 14 weeks
Improvement post treatment
Time frame: 2 weeks and 14 weeks
Improvement post treatment
Time frame: 2 weeks and 14 weeks
Improvement post treatment
Time frame: 2 weeks and 14 weeks
Improvement post treatment
Time frame: 2 weeks and 14 weeks
Improvement post treatment
Time frame: 2 weeks and 14 weeks
No cognitive deterioration post treatment
Time frame: 2 weeks
Improvement post treatment
Time frame: 2 weeks
Improvement post treatment
Time frame: 2 week and 14 weeks
Improvement post treatment
Time frame: 14 weeks
frequency of adverse events in the active and sham arms
Time frame: 2 week and 14 weeks
Improvement post treatment
Hospital Israelita Albert Einstein
Other
Acronym: NEUROSTIM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02425345
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT05589402
Bone Diseases, Brain Diseases
Harlingen, Texas, United States
View Trial DetailsNCT06750692
Brain Diseases, Cardiovascular Diseases
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT04992195
Alzheimer Disease, Arterial Thromboembolism
Hong Kong
View Trial Details