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

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628561
• Other study ID #: tdcstroke
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 4, 2015
• Last updated: April 3, 2016
• Start date: January 2016
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

• Cerebral Infarction
• Cerebrovascular Disorders
• Stroke

Intervention

Device:
• Transcranial direct current stimulation

Behavioral:
• Constraint-Induced Movement Therapy

Locations

Country	Name	City	State
Brazil	Suellen Andrade	João Pessoa	PB

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 baseline and week 2	No
Secondary	Spasticity (Modified Ashworth Scale)		Baseline and Week 2	No
Secondary	Muscle strength (Medical Research Council Scale)		Baseline and Week 2	No