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

Sponsors

Lead sponsor: Federal University of Paraíba

Source 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.

Overall Status Completed
Start Date January 2016
Completion Date April 2016
Primary Completion Date February 2016
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Functional Independence measured by Barthel Index Change for functional independence at baseline and week 2
Secondary Outcome
Measure Time Frame
Spasticity (Modified Ashworth Scale) Baseline and Week 2
Muscle strength (Medical Research Council Scale) Baseline and Week 2
Enrollment 60
Condition
Intervention

Intervention type: Device

Intervention name: Transcranial direct current stimulation

Intervention type: Behavioral

Intervention name: Constraint-Induced Movement Therapy

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Location
facility
Suellen Andrade
Location Countries

Brazil

Verification Date

April 2016

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Federal University of Paraíba

Investigator full name: Suellen Marinho Andrade

Investigator title: PhD

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Active tdcs/M1

Arm group type: Active Comparator

Description: Anodal tDCS on primary motor cortex and CIMT (constraint induced movement therapy)

Arm group label: Active tdcs/Premotor

Arm group type: Experimental

Description: Anodal tDCS on premotor cortex and CIMT (constraint induced movement therapy)

Arm group label: Sham tdcs

Arm group type: Sham Comparator

Description: Sham tDCS and CIMT (constraint induced movement therapy)

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov