Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke

Phase 1

Completed

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

• Registration Number: NCT02628561
• Lead Sponsor: Federal University of Paraíba

Brief Summary

The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.

Detailed Description

Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.

Study Timeline

• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Study Start: 2016-01
• Primary Completion: 2016-02
• Status Verified: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-03
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age between 18 and 65 years
• Diagnosis of unilateral, non-recurring, subacute stroke
• Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it.

Exclusion Criteria

• Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tdcs/M1	Constraint-Induced Movement Therapy	Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)
Active tdcs/Premotor	Transcranial direct current stimulation	Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)
Active tdcs/Premotor	Constraint-Induced Movement Therapy	Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)
Sham tdcs	Transcranial direct current stimulation	Sham tDCS and CIMT (constraint induced movement therapy)
Active tdcs/M1	Transcranial direct current stimulation	Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)
Sham tdcs	Constraint-Induced Movement Therapy	Sham tDCS and CIMT (constraint induced movement therapy)

Primary Outcome Measures

Name	Time	Method
Functional Independence measured by Barthel Index	Change for functional independence at baseline and week 2

Secondary Outcome Measures

Name	Time	Method
Muscle strength (Medical Research Council Scale)	Baseline and Week 2
Spasticity (Modified Ashworth Scale)	Baseline and Week 2

Trial Locations

Locations (1)

Suellen Andrade; 🇧🇷 João Pessoa, PB, Brazil