Stroke Clinical Trial
— START-tDCSOfficial title:
A Double-blind, Sham-controlled, Randomized Clinical Trial on Stroke Treatment Using Transcranial Direct Current Stimulation
The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | July 2017 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Ischaemic acute stroke - Informed consent Exclusion Criteria: - 25 = National Institute of Health Stroke Scale = 32 - Rankim = 5 - Mini Mental State Examination = 24 - tDCS criteria: use of modulators of the Central Nervous System drugs; patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy;any other condition that might limit or interfere in the sensorimotor system CIMT criteria: inability to actively execute the movements of wrist flexion, metacarpophalangeal and interphalangeal active extension of 10º and wrist extension of 20º |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of Paraíba,Department of Psychology | João Pessoa | Paraíba |
Lead Sponsor | Collaborator |
---|---|
Federal University of Paraíba |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Independence measured by Barthel Index | Change for functional independence at 4 months | No | |
Secondary | Cognitive dysfunction (Montreal Cognitive Assessment) | Baseline (week 1) and Endpoint (week 4) | Yes | |
Secondary | Executive functions (Victoria version of the Stroop Color and Word Test) | Baseline (week 1) and Endpoint (week 4) | Yes | |
Secondary | Attention and Working Memory (Digit span subtest) | Baseline (week 1) and Endpoint (week 4) | Yes | |
Secondary | Spasticity | Baseline, Week 2 and Week 4 | No | |
Secondary | Muscle strength | Baseline, Week 2 and Week 4 | No | |
Secondary | Balance | Baseline, Week 2 and Week 4 | No | |
Secondary | Posture | Baseline, Week 2 and Week 4 | No | |
Secondary | Fear of falling during daily life activities | Baseline, Week 2 and Week 4 | No | |
Secondary | Upper limb function | Baseline, Week 2 and Week 4 | No | |
Secondary | Quality of life | Baseline, Week 2 and Week 4 | No | |
Secondary | Lower limb function | Baseline, Week 2 and Week 4 | No |
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