Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke

Federal University of Paraíba

Status and phase: Completed; Phase 3; Phase 2

Conditions: Stroke

Treatments: Device: Sham transcranial direct current stimulation; Device: Bilateral transcranial direct current stimulation; Device: Cathodal transcranial direct current stimulation; Device: Anodal transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02422173

tdcs002

Details and patient eligibility

About

Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.

Full description

This is a randomized sham-controlled trial reported following the 2010 CONSORT guidelines. The subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study design. Each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham stimulation at 2 mA intensity and current density equivalent to 0.05 A/m2.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of acute stroke
• Able to walk 10m independently
• High risk of falling

Exclusion criteria

• Severe functional limitations
• Cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups

Anodal tDCS

Experimental group

Description:

Participants in the acute post-stroke stage will receive anodal transcranial direct current stimulation

Treatment:

Device: Anodal transcranial direct current stimulation

Cathodal tDCS

Experimental group

Description:

Participants in the acute post-stroke stage will receive cathodal transcranial direct current stimulation

Treatment:

Device: Cathodal transcranial direct current stimulation

Bilateral tDCS

Experimental group

Description:

Participants in the acute post-stroke stage will receive bilateral transcranial direct current stimulation

Treatment:

Device: Bilateral transcranial direct current stimulation

Sham tDCS

Sham Comparator group

Description:

Participants in the acute post-stroke stage will receive sham transcranial direct current stimulation

Treatment:

Device: Sham transcranial direct current stimulation