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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02628561

Enrollment

Registered

2015-12-11

Start date

2016-01-31

Completion date

2016-04-30

Last updated

2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Cerebrovascular Disorders, Cerebral Infarction

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.

Interventions

DEVICETranscranial direct current stimulation

BEHAVIORALConstraint-Induced Movement Therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026