Stroke Treatment Associate to Rehabilitation Therapy and Transcranial DC Stimulation (START-tDCS)

December 4, 2015 updated by: Suellen Marinho Andrade, Federal University of Paraíba

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58051-900
        • Federal University of Paraíba,Department of Psychology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active tdcs / CIMT
Participants in the acute post-stroke stage will receive active tDCS associate to rehabilitation (CIMT)
Device: Transcranial direct current stimulation
Behavioral: Constraint-Induced Movement Therapy
Sham Comparator: Sham stimulation / CIMT
Participants in the acute post-stroke stage will receive sham stimulation associate to rehabilitation (CIMT)
Other: Placebo
Behavioral: Constraint-Induced Movement Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional Independence measured by Barthel Index
Time Frame: Change for functional independence at 4 months
Change for functional independence at 4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Paraíba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 30, 2014

First Posted (Estimate)

June 5, 2014

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDCS 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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