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

Stroke Clinical Trial

Official title:

Effects of Different Montages of Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02422173
• Other study ID #: tdcs002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 14, 2015
• Last updated: April 16, 2015
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of acute stroke

• Able to walk 10m independently

• High risk of falling

Exclusion Criteria:

• Severe functional limitations

• Cognitive impairment

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

• Stroke

Intervention

Device:
• Anodal transcranial direct current stimulation
The active electrode is placed on the affected hemisphere
• Cathodal transcranial direct current stimulation
The active electrode is placed on the unaffected hemisphere
• Bilateral transcranial direct current stimulation
The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.
• Sham transcranial direct current stimulation
Placebo stimulation, with emission current by only 30 seconds

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Four Square Step Test		Change from Baseline in Risk of Falls at 3 months	No
Secondary	Occurrence of Falling Index		Baseline, Week 2, Week 4 and Week 12	No
Secondary	Overall Stability Index		Baseline, Week 2, Week 4 and Week 12	No
Secondary	Falls Efficacy Scale - International		Baseline, Week 2, Week 4 and Week 12	No
Secondary	Berg Balance Scale		Baseline, Week 2, Week 4 and Week 12	No
Secondary	Six-minute walk test		Baseline, Week 2, Week 4 and Week 12	No
Secondary	Sit to Stand Test		Baseline, Week 2, Week 4 and Week 12	No