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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02156635
Other study ID # TDCS 001
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received May 26, 2014
Last updated December 4, 2015
Start date February 2016
Est. completion date July 2017

Study information

Verified date December 2015
Source Federal University of Paraíba
Contact Suellen Andrade
Email suellenandrade@gmail.com
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

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


Description:

Stroke is defined as an acute neurological dysfunction of vascular origin, with subtle development of clinical signs of cerebral function disturbs, lasting more than 24h. The traditional therapy includes drugs and physical rehabilitation, without systematization, with complicates its replication. The transcranial direct current (DC) stimulation might promote an increase in the motor function of the hands, when compared with placebo stimulation.

In fact, some clinical trials point positive effects of transcranial DC stimulation (tDCS) as a post-stroke intervention, however, in general, they only include patients in the chronic stage, with cerebral damage in different areas and diverse disabilities, most being assisted by non-standardized physical therapy treatments. tDCS combined with a standardized physiotherapy program, noted as constraint-induced movement therapy (CIMT), could be able to modulate the cortical excitability and promote better functional recovery.

However, no relate of longitudinal studies assessing patients in the acute stage submitted to tDCS and physiotherapy for more than 6 months have been found. Studies like this would help us elucidate the action mechanisms of this treatment in the early stages of stroke.

With this in mind, START - tDCS, a phase II/III clinical trial, will be developed to assess the therapeutic effects of the tDCS in early stage enrolling 40 post-stroke patients. They will be allocated in 2 groups at random to receive active tDCS or sham, associate to CIMT. The protocol will be applied in a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be followed for 1 month. By the end of the study, the participants that receive tDCS and show better clinical condition will be invited to participate in bimonthly stimulation for 12 months, as part of a longitudinal study regarding tDCS for stroke. An increase in the clinical condition will be considered as a final score higher than 10 points in the Barthel Index, our primary outcome, when compared with baseline, before the treatment protocol.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Transcranial direct current stimulation

Behavioral:
Constraint-Induced Movement Therapy

Other:
Placebo


Locations

Country Name City State
Brazil Federal University of Paraíba,Department of Psychology João Pessoa Paraíba

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

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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