Stroke Treatment Associate to Rehabilitation Therapy and Transcranial DC Stimulation

Phase 2

• Conditions: Stroke; Cerebrovascular Disorders; Cerebral Infarction
• Interventions: Device: Transcranial direct current stimulation; Behavioral: Constraint-Induced Movement Therapy; Other: Placebo

• Registration Number: NCT02156635
• Lead Sponsor: Federal University of Paraíba

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2014-05-26
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-05
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-04
• Last Update Posted: 2015-12-07
• Study Start: 2016-02
• Primary Completion: 2016-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tdcs / CIMT	Constraint-Induced Movement Therapy	Participants in the acute post-stroke stage will receive active tDCS associate to rehabilitation (CIMT)
Sham stimulation / CIMT	Constraint-Induced Movement Therapy	Participants in the acute post-stroke stage will receive sham stimulation associate to rehabilitation (CIMT)
Active tdcs / CIMT	Transcranial direct current stimulation	Participants in the acute post-stroke stage will receive active tDCS associate to rehabilitation (CIMT)
Sham stimulation / CIMT	Placebo	Participants in the acute post-stroke stage will receive sham stimulation associate to rehabilitation (CIMT)

Primary Outcome Measures

Name	Time	Method
Functional Independence measured by Barthel Index	Change for functional independence at 4 months

Secondary Outcome Measures

Name	Time	Method
Muscle strength	Baseline, Week 2 and Week 4
Balance	Baseline, Week 2 and Week 4
Upper limb function	Baseline, Week 2 and Week 4
Spasticity	Baseline, Week 2 and Week 4
Quality of life	Baseline, Week 2 and Week 4
Lower limb function	Baseline, Week 2 and Week 4
Cognitive dysfunction (Montreal Cognitive Assessment)	Baseline (week 1) and Endpoint (week 4)
Attention and Working Memory (Digit span subtest)	Baseline (week 1) and Endpoint (week 4)
Executive functions (Victoria version of the Stroop Color and Word Test)	Baseline (week 1) and Endpoint (week 4)
Posture	Baseline, Week 2 and Week 4
Fear of falling during daily life activities	Baseline, Week 2 and Week 4

Trial Locations

Locations (1)

Federal University of Paraíba,Department of Psychology; 🇧🇷 João Pessoa, Paraíba, Brazil