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

Federal University of Paraíba

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cerebral Infarction; Stroke; Cerebrovascular Disorders

Treatments: Behavioral: Constraint-Induced Movement Therapy; Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02628561

tdcstroke

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Active tdcs/M1

Active Comparator group

Description:

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

Treatment:

Device: Transcranial direct current stimulation

Behavioral: Constraint-Induced Movement Therapy

Active tdcs/Premotor

Experimental group

Description:

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

Treatment:

Device: Transcranial direct current stimulation

Behavioral: Constraint-Induced Movement Therapy

Sham tdcs

Sham Comparator group

Description:

Sham tDCS and CIMT (constraint induced movement therapy)

Treatment:

Device: Transcranial direct current stimulation

Behavioral: Constraint-Induced Movement Therapy